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Image-Guided Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Shoulder, Arm, Hip, or Leg

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00589121
Recruitment Status : Completed
First Posted : January 9, 2008
Results First Posted : July 17, 2017
Last Update Posted : June 12, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Lymphedema
Musculoskeletal Complications
Radiation Fibrosis
Radiation Toxicity
Sarcoma
Interventions Drug: Chemotherapy
Radiation: Radiation therapy
Procedure: Surgery
Enrollment 98
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort A - Chemotherapy Cohort B - No Chemotherapy
Hide Arm/Group Description Radiation therapy with neoadjuvant or adjuvant or concurrent or interdigitated chemotherapy followed by surgery followed by, for patients with positive margins, radiation therapy boost Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
Period Title: Overall Study
Started 12 86
Completed 10 [1] 79 [1]
Not Completed 2 7
Reason Not Completed
Protocol Violation             2             6
No protocol treatment received             0             1
[1]
Subjects with data available for the analysis are considered to have completed the study.
Arm/Group Title Cohort A - Chemotherapy Cohort B - No Chemotherapy Total
Hide Arm/Group Description Radiation therapy with neoadjuvant or adjuvant or concurrent or interdigitated chemotherapy followed by surgery followed by, for patients with positive margins, radiation therapy boost Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost Total of all reporting groups
Overall Number of Baseline Participants 10 79 89
Hide Baseline Analysis Population Description
All eligible patients who started protocol treatment.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants 79 participants 89 participants
52
(30 to 71)
61
(24 to 88)
61
(24 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 79 participants 89 participants
Female
5
  50.0%
37
  46.8%
42
  47.2%
Male
5
  50.0%
42
  53.2%
47
  52.8%
1.Primary Outcome
Title Rate of Late Radiation Morbidity (≥ Grade 2 Lymphedema, Subcutaneous Fibrosis, or Joint Stiffness) at 2 Years From the Start of Radiotherapy as Measured by EORTC/RTOG Criteria
Hide Description The rate of patients with late radiation morbidity (≥ grade 2 lymphedema, subcutaneous fibrosis, or joint stiffness) at 2 years from the start of radiotherapy as measured by EORTC(European Organisation for Research and Treatment of Cancer)/RTOG (Radiation Therapy Oncology Group) criteria. Grade refers to the severity of the morbidity. The RTOG/EORTC Late Radiation Morbidity Scoring Schema assigns Grades 1 through 5 with unique clinical descriptions of severity for each morbidity based on this general guideline: Grade 1 Mild , Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to morbidity.
Time Frame 2 years after start of treatment (+/- 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients on Cohort B who started study treatment and had an assessment of toxicity at 2 years. (See limitations and caveats, Cohort A is not included.)
Arm/Group Title Cohort B - No Chemotherapy
Hide Arm/Group Description:
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
Overall Number of Participants Analyzed 57
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
10.5
(2.6 to 18.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort B - No Chemotherapy
Comments Initially designed to test for a 20% absolute improvement from 37% (fixed rate) to 17% using Fisher's exact test, requiring 41 patients per cohort (51 with 20% ineligibility) with 5% type I error and 90% statistical power. During accrual, the sample size for cohort B was increased to 66 (83 with 20% ineligibility) to test for a 15% improvement with 5% type I error and 85% power.
Type of Statistical Test Superiority or Other
Comments The fixed rate of 37% comes from the published National Cancer Institute of Canada trial SR2 (CAN-NCIC-SR2: Phase III Randomized Study of Pre- vs Postoperative Radiotherapy in Curable Extremity Soft Tissue Sarcoma) receiving preoperative radiation therapy without image-guided radiation therapy (IGRT).
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Local Failure Rate at Two Years
Hide Description Local failure is defined as the time from registration to date of failure (local progression) or death or last follow-up. Two year rate and 95% confidence interval were estimated by the cumulative incidence method.
Time Frame From registration to date of failure (local progression) or death or last follow-up. Report at time of primary outcome measure analysis.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)
Arm/Group Title Cohort B - No Chemotherapy
Hide Arm/Group Description:
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
Overall Number of Participants Analyzed 79
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
11.4
(5.6 to 19.6)
3.Secondary Outcome
Title Regional Failure Rate at Two Years
Hide Description Regional failure is defined as the time from registration to date of failure (regional progression) or death or last follow-up. Two year rate and 95% confidence interval were estimated by the cumulative incidence method.
Time Frame From registration to date of failure (regional progression) or death or last follow-up. Report at time of primary outcome measure analysis.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)
Arm/Group Title Cohort B - No Chemotherapy
Hide Arm/Group Description:
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
Overall Number of Participants Analyzed 79
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 0)
4.Secondary Outcome
Title Distant Failure Rate at Two Years
Hide Description Distant failure is defined as the time from registration to date of failure (distant progression) or death or last follow-up. Two year rate and 95% confidence interval were estimated by the cumulative incidence method.
Time Frame From registration to date of failure (distant progression) or death or last follow-up. Report at time of primary outcome measure analysis.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)
Arm/Group Title Cohort B - No Chemotherapy
Hide Arm/Group Description:
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
Overall Number of Participants Analyzed 79
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
37.3
(26.6 to 48)
5.Secondary Outcome
Title Distant Disease-free Survival Rate at Two Years
Hide Description Distant disease-free survival is defined as the time from registration to date of failure (distant progression or death) or last follow-up. Two year rate and 95% confidence interval were estimated by the Kaplan-Meier method.
Time Frame From registration to date of failure (distant progression or death) or last follow-up. Report at time of primary outcome measure analysis.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)
Arm/Group Title Cohort B - No Chemotherapy
Hide Arm/Group Description:
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
Overall Number of Participants Analyzed 79
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
61.4
(50.6 to 72.2)
6.Secondary Outcome
Title Disease-free Survival Rate at Two Years
Hide Description Disease-free survival is defined as the time from registration to date of failure (local, regional, or distant progression or death) or last follow-up. Two year rate and 95% confidence interval were estimated by the Kaplan-Meier method.
Time Frame From registration to date of failure (local, regional or distant progression or death) or last follow-up. Report at time of primary outcome measure analysis.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)
Arm/Group Title Cohort B - No Chemotherapy
Hide Arm/Group Description:
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
Overall Number of Participants Analyzed 79
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
58.1
(47.1 to 69.0)
7.Secondary Outcome
Title Overall Survival Rate at Two Years
Hide Description Overall survival is defined as the time from registration to date of death or last follow-up. Two year survival rate and 95% confidence interval were estimated by the Kaplan-Meier method.
Time Frame From registration to date of death or last follow-up. Report at time of primary outcome measure analysis.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)
Arm/Group Title Cohort B - No Chemotherapy
Hide Arm/Group Description:
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
Overall Number of Participants Analyzed 79
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
80.6
(71.8 to 89.4)
8.Secondary Outcome
Title Second Primary Tumor Rate at Two Years
Hide Description Second primary tumor is defined as the time from registration to date of failure (second primary tumor) or death or last follow-up. Two year rate and 95% confidence interval were estimated by the cumulative incidence method.
Time Frame From registration to date of failure (second primary tumor) or death or last follow-up. Report at time of primary outcome measure analysis.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)
Arm/Group Title Cohort B - No Chemotherapy
Hide Arm/Group Description:
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
Overall Number of Participants Analyzed 79
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
5.1
(1.7 to 11.7)
9.Secondary Outcome
Title Late Radiation Morbidity Rate (≥ Grade 2 Lymphedema, Subcutaneous Fibrosis or Joint Stiffness) at 2 Years From the Start of Radiotherapy as Measured by CTCAE v3.0
Hide Description Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
Time Frame 2 years after start of treatment (+/- 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients on Cohort B who started study treatment and had an assessment of toxicity at 2 years. (See limitations and caveats, Cohort A is not included.)
Arm/Group Title Cohort B - No Chemotherapy
Hide Arm/Group Description:
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
Overall Number of Participants Analyzed 57
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
8.8
(1.4 to 16.1)
10.Secondary Outcome
Title Percentage of Patients With Wound Complications
Hide Description Estimate rate of patients with acute wound complications with 95% confidence interval assuming binomial distribution.
Time Frame From date of surgery to 4 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients on cohort B that had surgery and a wound assessment. (See limitations and caveats, Cohort A is not included.)
Arm/Group Title Cohort B - No Chemotherapy
Hide Arm/Group Description:
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
Overall Number of Participants Analyzed 71
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
36.6
(25.4 to 47.8)
11.Secondary Outcome
Title Pattern of First Failure
Hide Description Pattern of first failure including local failure (in-field, marginal, and outside-field failure), regional failure, distant failure, and death without disease progression.
Time Frame From registration to date of local, regional or distant progression. Report at time of primary outcome measure analysis.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients on Cohort B who started study treatment. All eligible patients on Cohort B. (See limitations and caveats, Cohort A is not included.)
Arm/Group Title Cohort A - Chemotherapy Cohort B - No Chemotherapy
Hide Arm/Group Description:
Radiation therapy with neoadjuvant or adjuvant or concurrent or interdigitated chemotherapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
Overall Number of Participants Analyzed 10 79
Measure Type: Number
Unit of Measure: participants
Local 1 8
Regional 0 1
Distant 1 29
Dead without disease progression 0 2
Alive without disease progression 8 39
12.Secondary Outcome
Title Mean Musculoskeletal Tumor Rating Scale (MSTS) by Late Radiation Morbidity at Two Years
Hide Description

The Musculoskeletal Tumor Rating Scale (MSTS) is a measure of physical function across 7 items, completed by the physician (preferably by the Orthopedic Surgeon or Surgical Oncologist) or the physician's designated staff. The 7 items are: pain, range of motion, strength, joint stability, joint deformity, emotional, acceptance, and overall function. Each item is scored from 0-5 (worst possible to best possible condition). The item scores are summed to get the total score which ranges from 0-35.

Late radiation morbidity is defined as ≥ grade 2 lymphedema, subcutaneous fibrosis, or joint stiffness. Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.

Time Frame From start of treatment to 2 years.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients on Cohort B who had a 2-year MSTS assessment. (See limitations and caveats, Cohort A is not included.)
Arm/Group Title No Late Radiation Morbitity Has Late Radiation Toxicity
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 18 2
Mean (Standard Deviation)
Unit of Measure: units on a scale
31.3  (4.5) 25.0  (0)
13.Secondary Outcome
Title Percentage of Patients With Other CTCAE, v.3.0 Grade 3-5 Adverse Events
Hide Description Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
Time Frame From start of treatment to last follow-up. Analysis can occur at or after time of primary outcome measure analysis.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)
Arm/Group Title Cohort B - No Chemotherapy
Hide Arm/Group Description:
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
Overall Number of Participants Analyzed 79
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
38.0
(27.3 to 49.6)
14.Other Pre-specified Outcome
Title Correlation of Late Radiation Morbidity at 2 Years With the 3 Quality of Life Assessments [Functional Assessment of Cancer Therapy-General (FACTG), Toronto Extremity Salvage Score (TESS), and Sexual Adjustment Questionnaire (SAQ)]
Hide Description [Not Specified]
Time Frame 2 years after start of treatment (+/- 3 months)
Outcome Measure Data Not Reported
15.Other Pre-specified Outcome
Title Comparison of TESS and the MSTS Scores at 2 Years Between Cohort B Patients and the Preoperative Radiotherapy Patients in the NCIC CTG Trial [National Cancer Institute of Canada Clinical Trials Group]
Hide Description [Not Specified]
Time Frame 2 years after start of treatment (+/- 3 months)
Outcome Measure Data Not Reported
16.Other Pre-specified Outcome
Title Comparison of SAQ Scores at 2 Years for Cohort A Patients With Cohort B Patients
Hide Description [Not Specified]
Time Frame 2 years after start of treatment (+/- 3 months)
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description Subjects experiencing more than one of a given adverse event (AE) are counted only once for that adverse event. Data is reported for eligible patients with adverse event data who started study treatment.
 
Arm/Group Title Cohort A - Chemotherapy Cohort B - No Chemotherapy
Hide Arm/Group Description Radiation therapy with neoadjuvant or adjuvant or concurrent or interdigitated chemotherapy followed by surgery followed by, for patients with positive margins, radiation therapy boost Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
All-Cause Mortality
Cohort A - Chemotherapy Cohort B - No Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Cohort A - Chemotherapy Cohort B - No Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   2/10 (20.00%)   13/79 (16.46%) 
Blood and lymphatic system disorders     
Blood disorder * 1  1/10 (10.00%)  1/79 (1.27%) 
Hemoglobin decreased * 1  1/10 (10.00%)  0/79 (0.00%) 
Gastrointestinal disorders     
Nausea * 1  1/10 (10.00%)  0/79 (0.00%) 
Vomiting * 1  1/10 (10.00%)  0/79 (0.00%) 
General disorders     
Edema limbs  1  0/10 (0.00%)  2/79 (2.53%) 
Fatigue * 1  1/10 (10.00%)  0/79 (0.00%) 
Infections and infestations     
Infection [other] * 1  1/10 (10.00%)  0/79 (0.00%) 
Opportunistic infection * 1  0/10 (0.00%)  1/79 (1.27%) 
Skin infection [with normal or Grade 1-2 ANC] * 1  0/10 (0.00%)  3/79 (3.80%) 
Wound infection [with normal or Grade 1-2 ANC] * 1  0/10 (0.00%)  1/79 (1.27%) 
Injury, poisoning and procedural complications     
Arterial injury - Extremity-lower * 1  1/10 (10.00%)  0/79 (0.00%) 
Dermatitis radiation * 1  0/10 (0.00%)  1/79 (1.27%) 
Late RT Toxicity: subcutaneous tissue: NOS  2  0/10 (0.00%)  1/79 (1.27%) 
Postoperative hemorrhage * 1  1/10 (10.00%)  0/79 (0.00%) 
Investigations     
Laboratory test abnormal * 1  1/10 (10.00%)  0/79 (0.00%) 
Leukopenia * 1  1/10 (10.00%)  1/79 (1.27%) 
Lymphopenia * 1  1/10 (10.00%)  1/79 (1.27%) 
Neutrophil count decreased * 1  2/10 (20.00%)  1/79 (1.27%) 
Platelet count decreased * 1  0/10 (0.00%)  1/79 (1.27%) 
Musculoskeletal and connective tissue disorders     
Joint disorder  1  1/10 (10.00%)  1/79 (1.27%) 
Late RT Toxicity: joint: NOS  2  1/10 (10.00%)  1/79 (1.27%) 
Muscle weakness * 1  1/10 (10.00%)  0/79 (0.00%) 
Pain in extremity * 1  1/10 (10.00%)  1/79 (1.27%) 
Nervous system disorders     
Dizziness * 1  1/10 (10.00%)  0/79 (0.00%) 
Hydrocephalus * 1  0/10 (0.00%)  1/79 (1.27%) 
Neuralgia * 1  1/10 (10.00%)  0/79 (0.00%) 
Peripheral motor neuropathy * 1  0/10 (0.00%)  2/79 (2.53%) 
Psychiatric disorders     
Confusion * 1  0/10 (0.00%)  1/79 (1.27%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea * 1  0/10 (0.00%)  1/79 (1.27%) 
Skin and subcutaneous tissue disorders     
Decubitus ulcer * 1  1/10 (10.00%)  0/79 (0.00%) 
Skin disorder * 1  0/10 (0.00%)  1/79 (1.27%) 
Skin induration  1  0/10 (0.00%)  1/79 (1.27%) 
Vascular disorders     
Hematoma * 1  0/10 (0.00%)  1/79 (1.27%) 
Hemorrhage * 1  0/10 (0.00%)  1/79 (1.27%) 
Hypertension * 1  1/10 (10.00%)  0/79 (0.00%) 
Thrombosis * 1  1/10 (10.00%)  0/79 (0.00%) 
Vascular disorder * 1  1/10 (10.00%)  0/79 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
2
Term from vocabulary, RTOG/EORTC Late Tox.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort A - Chemotherapy Cohort B - No Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   8/10 (80.00%)   73/79 (92.41%) 
Blood and lymphatic system disorders     
Blood disorder * 1  1/10 (10.00%)  1/79 (1.27%) 
Febrile neutropenia * 1  1/10 (10.00%)  0/79 (0.00%) 
Hemoglobin decreased * 1  3/10 (30.00%)  19/79 (24.05%) 
Hemolysis * 1  1/10 (10.00%)  0/79 (0.00%) 
Cardiac disorders     
Arrhythmia supraventricular * 1  1/10 (10.00%)  0/79 (0.00%) 
Left ventricular failure * 1  1/10 (10.00%)  0/79 (0.00%) 
Palpitations * 1  1/10 (10.00%)  0/79 (0.00%) 
Premature ventricular contractions * 1  1/10 (10.00%)  0/79 (0.00%) 
Sinus tachycardia * 1  1/10 (10.00%)  0/79 (0.00%) 
Supraventricular tachycardia * 1  1/10 (10.00%)  0/79 (0.00%) 
Ear and labyrinth disorders     
Tinnitus * 1  1/10 (10.00%)  0/79 (0.00%) 
Eye disorders     
Diplopia * 1  1/10 (10.00%)  0/79 (0.00%) 
Vision blurred * 1  1/10 (10.00%)  0/79 (0.00%) 
Gastrointestinal disorders     
Abdominal pain * 1  1/10 (10.00%)  1/79 (1.27%) 
Constipation * 1  2/10 (20.00%)  4/79 (5.06%) 
Diarrhea * 1  1/10 (10.00%)  5/79 (6.33%) 
Ear, nose and throat examination abnormal * 1  2/10 (20.00%)  1/79 (1.27%) 
Gastritis * 1  1/10 (10.00%)  1/79 (1.27%) 
Gastrointestinal disorder * 1  1/10 (10.00%)  1/79 (1.27%) 
Nausea * 1  2/10 (20.00%)  13/79 (16.46%) 
Vomiting * 1  2/10 (20.00%)  5/79 (6.33%) 
General disorders     
Chills * 1  1/10 (10.00%)  3/79 (3.80%) 
Edema limbs * 1  0/10 (0.00%)  11/79 (13.92%) 
Edema limbs  1  6/10 (60.00%)  59/79 (74.68%) 
Fatigue * 1  3/10 (30.00%)  27/79 (34.18%) 
Fever * 1  1/10 (10.00%)  5/79 (6.33%) 
Gait abnormal * 1  1/10 (10.00%)  6/79 (7.59%) 
General symptom * 1  1/10 (10.00%)  1/79 (1.27%) 
Ill-defined disorder * 1  1/10 (10.00%)  0/79 (0.00%) 
Localized edema [trunk/genital] * 1  1/10 (10.00%)  3/79 (3.80%) 
Pain [NOS] * 1  1/10 (10.00%)  1/79 (1.27%) 
Pain [other] * 1  3/10 (30.00%)  10/79 (12.66%) 
Stern's Scale Toxicity: edema: NOS  2  6/10 (60.00%)  59/79 (74.68%) 
Infections and infestations     
Gastric infection [with unknown ANC] * 1  1/10 (10.00%)  0/79 (0.00%) 
Infection [other] * 1  0/10 (0.00%)  4/79 (5.06%) 
Skin infection [with normal or Grade 1-2 ANC] * 1  1/10 (10.00%)  1/79 (1.27%) 
Wound infection [with normal or Grade 1-2 ANC] * 1  2/10 (20.00%)  10/79 (12.66%) 
Wound infection [with unknown ANC] * 1  1/10 (10.00%)  1/79 (1.27%) 
Injury, poisoning and procedural complications     
Dermatitis radiation * 1  2/10 (20.00%)  22/79 (27.85%) 
Fracture * 1  0/10 (0.00%)  5/79 (6.33%) 
Late RT Toxicity: subcutaneous tissue: NOS  3  5/10 (50.00%)  25/79 (31.65%) 
Postoperative hemorrhage * 1  1/10 (10.00%)  0/79 (0.00%) 
Radiation recall reaction (dermatologic) * 1  1/10 (10.00%)  10/79 (12.66%) 
Seroma * 1  1/10 (10.00%)  10/79 (12.66%) 
Wound dehiscence * 1  0/10 (0.00%)  5/79 (6.33%) 
Investigations     
Activated partial thromboplastin time prolonged * 1  1/10 (10.00%)  1/79 (1.27%) 
Alanine aminotransferase increased * 1  2/10 (20.00%)  1/79 (1.27%) 
Alkaline phosphatase increased * 1  2/10 (20.00%)  2/79 (2.53%) 
Aspartate aminotransferase increased * 1  1/10 (10.00%)  1/79 (1.27%) 
Gamma-glutamyltransferase increased * 1  1/10 (10.00%)  1/79 (1.27%) 
Hyperbilirubinemia * 1  1/10 (10.00%)  1/79 (1.27%) 
Laboratory test abnormal * 1  1/10 (10.00%)  2/79 (2.53%) 
Leukopenia * 1  3/10 (30.00%)  4/79 (5.06%) 
Lymphopenia * 1  4/10 (40.00%)  7/79 (8.86%) 
Neutrophil count decreased * 1  1/10 (10.00%)  1/79 (1.27%) 
Platelet count decreased * 1  4/10 (40.00%)  1/79 (1.27%) 
Weight loss * 1  1/10 (10.00%)  5/79 (6.33%) 
Metabolism and nutrition disorders     
Acidosis * 1  1/10 (10.00%)  0/79 (0.00%) 
Anorexia * 1  2/10 (20.00%)  7/79 (8.86%) 
Dehydration * 1  1/10 (10.00%)  0/79 (0.00%) 
Hyperglycemia * 1  2/10 (20.00%)  4/79 (5.06%) 
Hyperkalemia * 1  1/10 (10.00%)  2/79 (2.53%) 
Hypoalbuminemia * 1  2/10 (20.00%)  4/79 (5.06%) 
Hypocalcemia * 1  1/10 (10.00%)  4/79 (5.06%) 
Hypokalemia * 1  2/10 (20.00%)  3/79 (3.80%) 
Hyponatremia * 1  3/10 (30.00%)  3/79 (3.80%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  1/10 (10.00%)  6/79 (7.59%) 
Buttock pain * 1  1/10 (10.00%)  3/79 (3.80%) 
Joint disorder * 1  1/10 (10.00%)  1/79 (1.27%) 
Joint disorder  1  6/10 (60.00%)  33/79 (41.77%) 
Joint pain * 1  1/10 (10.00%)  7/79 (8.86%) 
Late RT Toxicity: joint: NOS  3  6/10 (60.00%)  30/79 (37.97%) 
Muscle weakness * 1  1/10 (10.00%)  4/79 (5.06%) 
Muscle weakness lower limb * 1  2/10 (20.00%)  5/79 (6.33%) 
Musculoskeletal disorder * 1  2/10 (20.00%)  5/79 (6.33%) 
Myalgia * 1  1/10 (10.00%)  1/79 (1.27%) 
Neck pain * 1  2/10 (20.00%)  0/79 (0.00%) 
Pain in extremity * 1  2/10 (20.00%)  40/79 (50.63%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumor pain * 1  1/10 (10.00%)  2/79 (2.53%) 
Nervous system disorders     
Depressed level of consciousness * 1  1/10 (10.00%)  0/79 (0.00%) 
Dizziness * 1  1/10 (10.00%)  3/79 (3.80%) 
Extrapyramidal disorder * 1  1/10 (10.00%)  0/79 (0.00%) 
Headache * 1  1/10 (10.00%)  4/79 (5.06%) 
Neuralgia * 1  2/10 (20.00%)  4/79 (5.06%) 
Neurological disorder NOS * 1  0/10 (0.00%)  4/79 (5.06%) 
Peripheral motor neuropathy * 1  0/10 (0.00%)  8/79 (10.13%) 
Peripheral sensory neuropathy * 1  1/10 (10.00%)  18/79 (22.78%) 
Phantom pain * 1  1/10 (10.00%)  0/79 (0.00%) 
Speech disorder * 1  1/10 (10.00%)  0/79 (0.00%) 
Taste alteration * 1  1/10 (10.00%)  1/79 (1.27%) 
Psychiatric disorders     
Anxiety * 1  0/10 (0.00%)  4/79 (5.06%) 
Depression * 1  2/10 (20.00%)  2/79 (2.53%) 
Insomnia * 1  0/10 (0.00%)  4/79 (5.06%) 
Renal and urinary disorders     
Proteinuria * 1  1/10 (10.00%)  0/79 (0.00%) 
Urinary retention * 1  0/10 (0.00%)  4/79 (5.06%) 
Reproductive system and breast disorders     
Erectile dysfunction * 1  1/10 (10.00%)  0/79 (0.00%) 
Gynecomastia * 1  1/10 (10.00%)  0/79 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Bronchopulmonary hemorrhage * 1  1/10 (10.00%)  0/79 (0.00%) 
Cough * 1  1/10 (10.00%)  6/79 (7.59%) 
Dyspnea * 1  2/10 (20.00%)  4/79 (5.06%) 
Hemorrhage nasal * 1  1/10 (10.00%)  0/79 (0.00%) 
Hypoxia * 1  1/10 (10.00%)  1/79 (1.27%) 
Pleural effusion * 1  1/10 (10.00%)  1/79 (1.27%) 
Pneumothorax * 1  1/10 (10.00%)  0/79 (0.00%) 
Respiratory disorder * 1  1/10 (10.00%)  0/79 (0.00%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  4/10 (40.00%)  3/79 (3.80%) 
Decubitus ulcer * 1  1/10 (10.00%)  4/79 (5.06%) 
Erythema multiforme * 1  1/10 (10.00%)  2/79 (2.53%) 
Pain of skin * 1  0/10 (0.00%)  7/79 (8.86%) 
Pruritus * 1  1/10 (10.00%)  2/79 (2.53%) 
Rash desquamating * 1  2/10 (20.00%)  7/79 (8.86%) 
Skin disorder * 1  1/10 (10.00%)  9/79 (11.39%) 
Skin hyperpigmentation * 1  2/10 (20.00%)  14/79 (17.72%) 
Skin induration * 1  1/10 (10.00%)  1/79 (1.27%) 
Skin induration  1  5/10 (50.00%)  38/79 (48.10%) 
Sweating * 1  1/10 (10.00%)  0/79 (0.00%) 
Telangiectasia * 1  1/10 (10.00%)  0/79 (0.00%) 
Vascular disorders     
Hematoma * 1  2/10 (20.00%)  3/79 (3.80%) 
Hypertension * 1  1/10 (10.00%)  0/79 (0.00%) 
Hypotension * 1  1/10 (10.00%)  1/79 (1.27%) 
Thrombosis * 1  1/10 (10.00%)  4/79 (5.06%) 
Vascular disorder * 1  2/10 (20.00%)  1/79 (1.27%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
2
Term from vocabulary, Stern's Edema Scale
3
Term from vocabulary, RTOG/EORTC Late Tox.
Due to unmet accrual goals for Cohort A, the decision was made to close this cohort and to increase the sample size of Cohort B. Due to the small sample size for Cohort A results were not reported.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Wendy Seiferheld, M.S.
Organization: NRG Oncology
EMail: seiferheldw@nrgoncology.org
Layout table for additonal information
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00589121    
Other Study ID Numbers: RTOG-0630
CDR0000582196
First Submitted: January 5, 2008
First Posted: January 9, 2008
Results First Submitted: August 25, 2016
Results First Posted: July 17, 2017
Last Update Posted: June 12, 2019