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Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction

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ClinicalTrials.gov Identifier: NCT00069953
Recruitment Status : Completed
First Posted : October 7, 2003
Results First Posted : October 20, 2014
Last Update Posted : February 17, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Esophageal Cancer
Interventions Biological: filgrastim
Biological: pegfilgrastim
Drug: cisplatin
Drug: fluorouracil
Drug: paclitaxel
Procedure: conventional surgery
Radiation: radiation therapy
Enrollment 43
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ChemoRT and Selective Surgery
Hide Arm/Group Description Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
Period Title: Overall Study
Started 43
Completed 41 [1]
Not Completed 2
Reason Not Completed
Protocol Violation             2
[1]
Subjects with data available for the primary analysis are considered to have completed the study
Arm/Group Title ChemoRT and Selective Surgery
Hide Arm/Group Description Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
Overall Number of Baseline Participants 41
Hide Baseline Analysis Population Description
All eligible patients.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 41 participants
59
(42 to 81)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
Female
7
  17.1%
Male
34
  82.9%
1.Primary Outcome
Title Overall Survival (1-year Rate Reported)
Hide Description One-year survival estimate is reported. Survival time is defined as time from registration to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact. This analysis was planned to occur when all patients had been potentially followed for 1 year. On the basis of a 1-year survival rate of 60% from the Radiation Therapy Oncology Group (RTOG) esophageal database, 38 analyzable patients with a 1-year survival rate of 77.5% or better was needed for this trial to be deemed promising enough for development of a Phase III protocol (type I error of 0.05 and type II error of 0.20).
Time Frame From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 1 year.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible patients.
Arm/Group Title ChemoRT and Selective Surgery
Hide Arm/Group Description:
Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
Overall Number of Participants Analyzed 41
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
71
(54 to 82)
2.Secondary Outcome
Title Frequency of Major (Grade 4) Acute Treatment-related Toxicities
Hide Description [Not Specified]
Time Frame From start of chemotherapy to surgery or 2 months after chemoradiation (for patients not undergoing surgery).
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Frequency of Patients With Persistent or Recurrent Disease Eligible for Surgical Salvage Resection
Hide Description [Not Specified]
Time Frame Analysis occurs with the primary outcome measure.
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
 
Arm/Group Title ChemoRT and Selective Surgery
Hide Arm/Group Description Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
All-Cause Mortality
ChemoRT and Selective Surgery
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ChemoRT and Selective Surgery
Affected / at Risk (%)
Total   26/41 (63.41%) 
Blood and lymphatic system disorders   
Packed red blood cell transfusion * 1  1/41 (2.44%) 
Cardiac disorders   
Arrhythmia NOS * 1  1/41 (2.44%) 
Gastrointestinal disorders   
Diarrhea NOS * 1  4/41 (9.76%) 
Esophageal spasm * 1  5/41 (12.20%) 
Esophagitis NOS * 1  2/41 (4.88%) 
GI-other * 1  1/41 (2.44%) 
Nausea * 1  8/41 (19.51%) 
Tracheo-oesophageal fistula NOS * 1  1/41 (2.44%) 
Vomiting NOS * 1  4/41 (9.76%) 
General disorders   
Chest pain * 1  2/41 (4.88%) 
Pain due to radiation * 1  3/41 (7.32%) 
Pain-other * 1  3/41 (7.32%) 
Infections and infestations   
Infection NOS * 1  2/41 (4.88%) 
Infection, Other * 1  1/41 (2.44%) 
Investigations   
Neutropenia * 1  1/41 (2.44%) 
Metabolism and nutrition disorders   
Anorexia * 1  1/41 (2.44%) 
Dehydration * 1  3/41 (7.32%) 
Hyperglycemia NOS * 1  4/41 (9.76%) 
Hyponatremia * 1  1/41 (2.44%) 
Nervous system disorders   
Dizziness (exc vertigo) * 1  1/41 (2.44%) 
Peripheral sensory neuropathy * 1  1/41 (2.44%) 
Renal and urinary disorders   
Renal failure NOS * 1  1/41 (2.44%) 
Respiratory, thoracic and mediastinal disorders   
Adult respiratory distress syndrome * 1  1/41 (2.44%) 
Dyspnea NOS * 1  1/41 (2.44%) 
Hypoxia * 1  3/41 (7.32%) 
Late RT Toxicity: Lung: NOS  2  1/41 (2.44%) 
Pneumonitis NOS * 1  3/41 (7.32%) 
Pulmonary-other * 1  2/41 (4.88%) 
Vascular disorders   
Thrombosis NOS * 1  2/41 (4.88%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTC (2.0)
2
Term from vocabulary, RTOG/EORTC Late Tox.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ChemoRT and Selective Surgery
Affected / at Risk (%)
Total   41/41 (100.00%) 
Blood and lymphatic system disorders   
Hemoglobin decreased * 1  36/41 (87.80%) 
Gastrointestinal disorders   
Constipation * 1  18/41 (43.90%) 
Diarrhea NOS * 1  16/41 (39.02%) 
Dry mouth * 1  4/41 (9.76%) 
Dyspepsia * 1  7/41 (17.07%) 
Esophageal spasm * 1  11/41 (26.83%) 
Esophagitis NOS * 1  15/41 (36.59%) 
GI-other * 1  9/41 (21.95%) 
Late RT Toxicity: Esophagus: NOS  2  5/41 (12.20%) 
Nausea * 1  29/41 (70.73%) 
Stomatitis * 1  8/41 (19.51%) 
Vomiting NOS * 1  18/41 (43.90%) 
General disorders   
Chest pain * 1  3/41 (7.32%) 
Fatigue * 1  37/41 (90.24%) 
Pain due to radiation * 1  6/41 (14.63%) 
Pain-other * 1  11/41 (26.83%) 
Pyrexia * 1  4/41 (9.76%) 
Infections and infestations   
Infection NOS * 1  4/41 (9.76%) 
Injury, poisoning and procedural complications   
Dermatitis radiation NOS * 1  12/41 (29.27%) 
Investigations   
Alanine aminotransferase increased * 1  4/41 (9.76%) 
Aspartate aminotransferase increased * 1  6/41 (14.63%) 
Blood alkaline phosphatase NOS increased * 1  9/41 (21.95%) 
Blood bilirubin increased * 1  4/41 (9.76%) 
Blood creatinine increased * 1  5/41 (12.20%) 
Leukopenia NOS * 1  28/41 (68.29%) 
Lymphopenia * 1  7/41 (17.07%) 
Metabolic-Other * 1  3/41 (7.32%) 
Neutropenia * 1  14/41 (34.15%) 
Platelet count decreased * 1  24/41 (58.54%) 
Weight decreased * 1  19/41 (46.34%) 
Metabolism and nutrition disorders   
Anorexia * 1  22/41 (53.66%) 
Blood albumin decreased * 1  7/41 (17.07%) 
Blood magnesium decreased * 1  6/41 (14.63%) 
Dehydration * 1  7/41 (17.07%) 
Hypercalcemia * 1  3/41 (7.32%) 
Hyperglycemia NOS * 1  25/41 (60.98%) 
Hypocalcemia * 1  7/41 (17.07%) 
Hypoglycaemia NOS * 1  3/41 (7.32%) 
Hypokalemia * 1  8/41 (19.51%) 
Hyponatremia * 1  15/41 (36.59%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  13/41 (31.71%) 
Myalgia * 1  14/41 (34.15%) 
Nervous system disorders   
Dizziness (exc vertigo) * 1  8/41 (19.51%) 
Headache NOS * 1  3/41 (7.32%) 
Peripheral motor neuropathy * 1  3/41 (7.32%) 
Peripheral sensory neuropathy * 1  23/41 (56.10%) 
Taste disturbance * 1  9/41 (21.95%) 
Psychiatric disorders   
Insomnia NEC * 1  10/41 (24.39%) 
Renal and urinary disorders   
Renal/GU-Other * 1  3/41 (7.32%) 
Urinary frequency * 1  4/41 (9.76%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  10/41 (24.39%) 
Dysphonia * 1  4/41 (9.76%) 
Dyspnea NOS * 1  4/41 (9.76%) 
Hiccups * 1  4/41 (9.76%) 
Skin and subcutaneous tissue disorders   
Alopecia * 1  24/41 (58.54%) 
Dermatitis exfoliative NOS * 1  9/41 (21.95%) 
Localized exfoliation * 1  4/41 (9.76%) 
Vascular disorders   
Hypotension NOS * 1  6/41 (14.63%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTC (2.0)
2
Term from vocabulary, RTOG/EORTC Late Tox.
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
Name/Title: Wendy Seiferheld
Organization: NRG Oncology
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00069953     History of Changes
Other Study ID Numbers: RTOG-0246
CDR0000306455
First Submitted: October 3, 2003
First Posted: October 7, 2003
Results First Submitted: October 14, 2014
Results First Posted: October 20, 2014
Last Update Posted: February 17, 2017