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Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00346164
First Posted: June 29, 2006
Last Update Posted: October 6, 2017
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
Results First Submitted: April 25, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Adult Alveolar Soft-part Sarcoma
Adult Angiosarcoma
Adult Epithelioid Sarcoma
Adult Extraskeletal Chondrosarcoma
Adult Extraskeletal Osteosarcoma
Adult Fibrosarcoma
Adult Leiomyosarcoma
Adult Liposarcoma
Adult Malignant Fibrous Histiocytoma
Adult Malignant Hemangiopericytoma
Adult Malignant Mesenchymoma
Adult Neurofibrosarcoma
Adult Synovial Sarcoma
Childhood Alveolar Soft-part Sarcoma
Childhood Angiosarcoma
Childhood Epithelioid Sarcoma
Childhood Fibrosarcoma
Childhood Leiomyosarcoma
Childhood Liposarcoma
Childhood Malignant Mesenchymoma
Childhood Neurofibrosarcoma
Childhood Synovial Sarcoma
Dermatofibrosarcoma Protuberans
Metastatic Childhood Soft Tissue Sarcoma
Nonmetastatic Childhood Soft Tissue Sarcoma
Stage I Adult Soft Tissue Sarcoma
Stage II Adult Soft Tissue Sarcoma
Stage III Adult Soft Tissue Sarcoma
Stage IV Adult Soft Tissue Sarcoma
Interventions: Drug: doxorubicin hydrochloride
Other: clinical observation
Procedure: therapeutic conventional surgery
Radiation: 3-dimensional conformal radiation therapy
Drug: ifosfamide

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm A: No Adjuvant Treatment

Patients with low-grade tumor with either negative or positive microscopic margins or high-grade tumor ≤ 5 cm (in maximum diameter) with negative microscopic margins are assigned to arm A: (observation only).

clinical observation: Patients undergo observation

therapeutic conventional surgery: Patients undergo surgery

Arm B: Low Risk; Adjuvant Radiotherapy

Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to arm B: (adjuvant radiotherapy). Beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy.

clinical observation: Patients undergo observation

therapeutic conventional surgery: Patients undergo surgery

3-dimensional conformal radiation therapy: Patients undergo radiotherapy

Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy

High risk [metastatic, resected, incompletely resected, or unresected disease] patients with high-grade, grossly resected primary tumor, with metastases are assigned to receive arm C: (adjuvant chemoradiotherapy). Patients receive ifosfamide IV; doxorubicin hydrochloride IV; beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy.

doxorubicin hydrochloride: Given IV

clinical observation: Patients undergo observation

3-dimensional conformal radiation therapy: Patients undergo radiotherapy

ifosfamide: Given IV

Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy

High risk [metastatic, resected, incompletely resected, or unresected disease] patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in arm D: (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy): Patients receive ifosfamide IV; doxorubicin hydrochloride IV. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. Patients undergo surgical resection in week 13.

doxorubicin hydrochloride: Given IV

clinical observation: Patients undergo observation

therapeutic conventional surgery: Patients undergo surgery

3-dimensional conformal radiation therapy: Patients undergo radiotherapy

ifosfamide: Given IV


Participant Flow:   Overall Study
    Arm A: No Adjuvant Treatment   Arm B: Low Risk; Adjuvant Radiotherapy   Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy   Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy
STARTED   222   21   122   223 
COMPLETED   205   14   96   117 
NOT COMPLETED   17   7   26   106 
Adverse Event                0                0                0                1 
Lack of Efficacy                0                1                7                25 
Physician Decision                0                1                2                27 
Protocol Violation                6                2                10                4 
Withdrawal by Subject                0                0                2                0 
Ineligible                11                2                2                23 
Refusal of further protocol therapy                0                1                3                15 
Inability to start week 16 tx on time                0                0                0                11 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm A: No Adjuvant Treatment

Patients with low-grade tumor with either negative or positive microscopic margins or high-grade tumor ≤ 5 cm (in maximum diameter) with negative microscopic margins are assigned to arm A: (observation only).

clinical observation: Patients undergo observation

therapeutic conventional surgery: Patients undergo surgery

Arm B: Low Risk; Adjuvant Radiotherapy

Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to arm B: (adjuvant radiotherapy). Beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy.

clinical observation: Patients undergo observation

therapeutic conventional surgery: Patients undergo surgery

3-dimensional conformal radiation therapy: Patients undergo radiotherapy

Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy

High risk [metastatic, resected, incompletely resected, or unresected disease] patients with high-grade, grossly resected primary tumor, with metastases are assigned to receive arm C: (adjuvant chemoradiotherapy). Patients receive ifosfamide IV; doxorubicin hydrochloride IV; beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy.

doxorubicin hydrochloride: Given IV

clinical observation: Patients undergo observation

3-dimensional conformal radiation therapy: Patients undergo radiotherapy

ifosfamide: Given IV

Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy

High risk [metastatic, resected, incompletely resected, or unresected disease] patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in arm D: (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy): Patients receive ifosfamide IV; doxorubicin hydrochloride IV. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. Patients undergo surgical resection in week 13.

doxorubicin hydrochloride: Given IV

clinical observation: Patients undergo observation

therapeutic conventional surgery: Patients undergo surgery

3-dimensional conformal radiation therapy: Patients undergo radiotherapy

ifosfamide: Given IV

Total Total of all reporting groups

Baseline Measures
   Arm A: No Adjuvant Treatment   Arm B: Low Risk; Adjuvant Radiotherapy   Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy   Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 222   21   122   223   588 
Age 
[Units: Months]
Mean (Standard Deviation)
 138.87  (60.88)   142.58  (59.46)   155.14  (69.20)   171.31  (68.90)   154.68  (67.10) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      124  55.9%      9  42.9%      60  49.2%      120  53.8%      313  53.2% 
Male      98  44.1%      12  57.1%      62  50.8%      103  46.2%      275  46.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
         
Hispanic or Latino      29  13.1%      1   4.8%      22  18.0%      38  17.0%      90  15.3% 
Not Hispanic or Latino      185  83.3%      19  90.5%      95  77.9%      178  79.8%      477  81.1% 
Unknown or Not Reported      8   3.6%      1   4.8%      5   4.1%      7   3.1%      21   3.6% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
         
American Indian or Alaska Native      1   0.5%      0   0.0%      2   1.6%      3   1.3%      6   1.0% 
Asian      7   3.2%      1   4.8%      2   1.6%      8   3.6%      18   3.1% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      1   0.4%      1   0.2% 
Black or African American      23  10.4%      2   9.5%      21  17.2%      43  19.3%      89  15.1% 
White      169  76.1%      16  76.2%      90  73.8%      137  61.4%      412  70.1% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      22   9.9%      2   9.5%      7   5.7%      31  13.9%      62  10.5% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Probability for Event Free Survival.   [ Time Frame: 5 years ]

2.  Secondary:   Toxicity Rate   [ Time Frame: 13 weeks ]

3.  Secondary:   Complete or Partial Response Rate   [ Time Frame: 13 weeks ]

4.  Secondary:   Percent Tumor Necrosis   [ Time Frame: 13 weeks ]

5.  Secondary:   Event Free Survival Probability Disease Extent   [ Time Frame: 5 years ]

6.  Secondary:   Event Free Survival Probability Histologic Grade   [ Time Frame: 5 years ]

7.  Secondary:   Overall Survival Probability Disease Extent   [ Time Frame: 5 years ]

8.  Secondary:   Overall Survival Probability Extent of Resection of the Primary Tumor   [ Time Frame: 5 years ]

9.  Secondary:   Incidence of Distant Metastasis   [ Time Frame: Up to 10 years ]

10.  Secondary:   Incidence of Distant Metastasis   [ Time Frame: Up to 10 years ]

11.  Secondary:   Genetic and Gene Expression Profiles   [ Time Frame: At diagnosis ]

12.  Secondary:   Degree of Agreement in Histologic Grade Determined by the Enrolling Institution Versus by Central Pathology Reviewers   [ Time Frame: At Diagnosis ]

13.  Secondary:   Degree of Agreement in Histologic Grade Between Pediatric Oncology Group (POG) and Fédération Nationale Des Centres de Lutte Contre le Cancer (FNCLCC) Pathologic Grading Systems   [ Time Frame: At diagnosis ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
phone: 626-447-0064
e-mail: resultsreportingcoordintator@childrensoncologygroup.org



Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00346164     History of Changes
Other Study ID Numbers: ARST0332
NCI-2009-00426 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-ARST0332 ( Other Identifier: Children's Oncology Group )
CDR0000483702 ( Other Identifier: Clinical Trials.gov )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: June 28, 2006
First Posted: June 29, 2006
Results First Submitted: April 25, 2016
Results First Posted: October 6, 2017
Last Update Posted: October 6, 2017