Trial Outcomes & Findings for Phase II Trial of Preoperative Combined Modality Therapy for Esophageal Carcinoma: Cisplatin-Irinotecan Followed by Radiation Therapy With Concurrent Cisplatin and Irinotecan. (NCT NCT00590031)

Last Updated: 2016-01-25

Results Overview

Pathological information will be available for all patients who receive surgery. If a patient is deemed unresectable based on clinical and radiological examination after the therapy, that patient will be counted as non-responder. The best overall response is the best response recorded from the start of treatment until disease progression (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The subject's best response assignment will depend on the achievement of both measurement and confirmation criteria. We will also estimate the pathological complete response rates separately for each of these tumor types. Survival and disease-free survival will be estimated using Kaplan-Meier method. With an accrual rate of 3 patients a month, we expect the study to be completed in 18 months.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

61 participants

Primary outcome timeframe

2 years

Results posted on

2016-01-25

Participant Flow

Participant milestones

Participant milestones
Measure	Combined Modality Therapy for Esophageal Carcinoma The trial will be a phase II, single institution trial of preoperative therapy with irinotecan, cisplatin, and concurrent radiotherapy in surgically resectable esophageal cancer. The primary endpoint is the pathologic complete response rate to preoperative therapy, and a sample size of 50 patients will characterize this response rate +/- 13% with 95% confidence. Secondary endpoints will include the toxicity of therapy, including surgical morbidity and mortality, the overall and disease-free survival, pattern of disease recurrence, and quality of life achieved during therapy, including relief of dysphagia.
Overall Study STARTED	61
Overall Study COMPLETED	55
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Combined Modality Therapy for Esophageal Carcinoma The trial will be a phase II, single institution trial of preoperative therapy with irinotecan, cisplatin, and concurrent radiotherapy in surgically resectable esophageal cancer. The primary endpoint is the pathologic complete response rate to preoperative therapy, and a sample size of 50 patients will characterize this response rate +/- 13% with 95% confidence. Secondary endpoints will include the toxicity of therapy, including surgical morbidity and mortality, the overall and disease-free survival, pattern of disease recurrence, and quality of life achieved during therapy, including relief of dysphagia.
Overall Study Adverse Event	3
Overall Study Withdrawal by Subject	1
Overall Study Metastatic Disease	1
Overall Study Admin Hold	1

Baseline Characteristics

Phase II Trial of Preoperative Combined Modality Therapy for Esophageal Carcinoma: Cisplatin-Irinotecan Followed by Radiation Therapy With Concurrent Cisplatin and Irinotecan.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Combined Modality Therapy for Esophageal Carcinoma n=55 Participants The trial will be a phase II, single institution trial of preoperative therapy with irinotecan, cisplatin, and concurrent radiotherapy in surgically resectable esophageal cancer. The primary endpoint is the pathologic complete response rate to preoperative therapy, and a sample size of 50 patients will characterize this response rate +/- 13% with 95% confidence. Secondary endpoints will include the toxicity of therapy, including surgical morbidity and mortality, the overall and disease-free survival, pattern of disease recurrence, and quality of life achieved during therapy, including relief of dysphagia.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants
Region of Enrollment United States	55 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Combined Modality Therapy for Esophageal Carcinoma n=55 Participants The trial will be a phase II, single institution trial of preoperative therapy with irinotecan, cisplatin, and concurrent radiotherapy in surgically resectable esophageal cancer. The primary endpoint is the pathologic complete response rate to preoperative therapy, and a sample size of 50 patients will characterize this response rate +/- 13% with 95% confidence. Secondary endpoints will include the toxicity of therapy, including surgical morbidity and mortality, the overall and disease-free survival, pattern of disease recurrence, and quality of life achieved during therapy, including relief of dysphagia.
Pathologic Complete Response	55 participants

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Combined Modality Therapy for Esophageal Carcinoma n=55 Participants The trial will be a phase II, single institution trial of preoperative therapy with irinotecan, cisplatin, and concurrent radiotherapy in surgically resectable esophageal cancer. The primary endpoint is the pathologic complete response rate to preoperative therapy, and a sample size of 50 patients will characterize this response rate +/- 13% with 95% confidence. Secondary endpoints will include the toxicity of therapy, including surgical morbidity and mortality, the overall and disease-free survival, pattern of disease recurrence, and quality of life achieved during therapy, including relief of dysphagia.
Evaluate Toxicity and Tolerability Including Surgical Morbidity and Mortality	55 participants

Adverse Events

Combined Modality Therapy for Esophageal Carcinoma

Serious events: 22 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Combined Modality Therapy for Esophageal Carcinoma n=55 participants at risk The trial will be a phase II, single institution trial of preoperative therapy with irinotecan, cisplatin, and concurrent radiotherapy in surgically resectable esophageal cancer. The primary endpoint is the pathologic complete response rate to preoperative therapy, and a sample size of 50 patients will characterize this response rate +/- 13% with 95% confidence. Secondary endpoints will include the toxicity of therapy, including surgical morbidity and mortality, the overall and disease-free survival, pattern of disease recurrence, and quality of life achieved during therapy, including relief of dysphagia.
Metabolism and nutrition disorders Anorexia	1.8% 1/55 • Number of events 1
Cardiac disorders Atrial fibrillation	1.8% 1/55 • Number of events 2
Cardiac disorders Cardiovascular, Arrhythmia other	1.8% 1/55 • Number of events 1
Cardiac disorders Chest pain	1.8% 1/55 • Number of events 1
Gastrointestinal disorders Constipation	1.8% 1/55 • Number of events 1
Respiratory, thoracic and mediastinal disorders Cough	1.8% 1/55 • Number of events 2
Gastrointestinal disorders Dehydration	14.5% 8/55 • Number of events 10
Gastrointestinal disorders Diarrhea (Pts w/out col)	10.9% 6/55 • Number of events 6
Gastrointestinal disorders Dysphagia, esophagitis	1.8% 1/55 • Number of events 1
Gastrointestinal disorders Dysphagia-esophageal	5.5% 3/55 • Number of events 3
Respiratory, thoracic and mediastinal disorders Dyspnea	5.5% 3/55 • Number of events 4
General disorders Fatigue	1.8% 1/55 • Number of events 1
Blood and lymphatic system disorders Febrile neutropenia	3.6% 2/55 • Number of events 2
Metabolism and nutrition disorders Hyperglycemia	1.8% 1/55 • Number of events 1
Metabolism and nutrition disorders Hyponatremia	1.8% 1/55 • Number of events 1
Gastrointestinal disorders Nausea	5.5% 3/55 • Number of events 3
Investigations Neutrophil count decr	1.8% 1/55 • Number of events 1
Vascular disorders Phlebitis	1.8% 1/55 • Number of events 1
Investigations Platelet count decreased	1.8% 1/55 • Number of events 1
Nervous system disorders Syncope	1.8% 1/55 • Number of events 1
Vascular disorders Thrombosis	16.4% 9/55 • Number of events 10
Renal and urinary disorders Urinary frequency	1.8% 1/55 • Number of events 1
Gastrointestinal disorders Vomiting	3.6% 2/55 • Number of events 2

Other adverse events

Other adverse events
Measure	Combined Modality Therapy for Esophageal Carcinoma n=55 participants at risk The trial will be a phase II, single institution trial of preoperative therapy with irinotecan, cisplatin, and concurrent radiotherapy in surgically resectable esophageal cancer. The primary endpoint is the pathologic complete response rate to preoperative therapy, and a sample size of 50 patients will characterize this response rate +/- 13% with 95% confidence. Secondary endpoints will include the toxicity of therapy, including surgical morbidity and mortality, the overall and disease-free survival, pattern of disease recurrence, and quality of life achieved during therapy, including relief of dysphagia.
Investigations Alkaline phosphatase	5.5% 3/55 • Number of events 3
Skin and subcutaneous tissue disorders Alopecia	7.3% 4/55 • Number of events 5
Metabolism and nutrition disorders Anorexia	9.1% 5/55 • Number of events 5
Investigations Bilirubin	20.0% 11/55 • Number of events 50
Respiratory, thoracic and mediastinal disorders Dyspnea	14.5% 8/55 • Number of events 10
Investigations Creatinine	9.1% 5/55 • Number of events 30
Gastrointestinal disorders Diarrhea (Pts w/out col)	9.1% 5/55 • Number of events 5
Gastrointestinal disorders Dysphagia, esophagitis	12.7% 7/55 • Number of events 7
Gastrointestinal disorders Dysphagia-esophageal	9.1% 5/55 • Number of events 5
General disorders Fatigue	36.4% 20/55 • Number of events 20
Blood and lymphatic system disorders Hemoglobin (Hgb)	90.9% 50/55 • Number of events 200
Metabolism and nutrition disorders Hyperglycemia	65.5% 36/55 • Number of events 200
Metabolism and nutrition disorders Hyperkalemia	10.9% 6/55 • Number of events 15
Metabolism and nutrition disorders Hypoalbuminemia	38.2% 21/55 • Number of events 40
Metabolism and nutrition disorders Hypocalcemia	80.0% 44/55 • Number of events 200
Metabolism and nutrition disorders Hypokalemia	10.9% 6/55 • Number of events 7
Metabolism and nutrition disorders Hypomagnesemia	27.3% 15/55 • Number of events 50
Metabolism and nutrition disorders Hyponatremia	9.1% 5/55 • Number of events 13
Metabolism and nutrition disorders Hypophosphatemia	72.7% 40/55 • Number of events 100
Blood and lymphatic system disorders Leukocytes	87.3% 48/55 • Number of events 250
Blood and lymphatic system disorders Lymphopenia	90.9% 50/55 • Number of events 250
Gastrointestinal disorders Nausea	20.0% 11/55 • Number of events 15
Investigations Neutrophils/gran	65.5% 36/55 • Number of events 125
Investigations PT	16.4% 9/55 • Number of events 50
Investigations PTT	18.2% 10/55 • Number of events 40
Investigations Platelets	27.3% 15/55 • Number of events 45
Investigations SGOT (AST)	9.1% 5/55 • Number of events 14
Investigations SGPT (ALT)	12.7% 7/55 • Number of events 9

Additional Information

Dr. David Ilson, Attending

Memorial Sloan Kettering Cancer Center

Phone: +1646-888-4183

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place