Back to resultsPhase II Trial of Preoperative Combined Modality Therapy for Esophageal Carcinoma: Cisplatin-Irinotecan Followed by Radiation Therapy With Concurrent Cisplatin and Irinotecan.
Primary Purpose
Esophageal Carcinoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cisplatin
Irinotecan
External Beam Radiation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Carcinoma focused on measuring Esophageal Carcinoma, Cisplatin, Irinotecan, Radiation Therapy, 02-045
Eligibility Criteria
Inclusion Criteria:
- Patients must be able to sign the informed consent document.
Exclusion Criteria:
- Tis (in-situ carcinoma) and tumors determined to be TIN0 following endoscopy, endoscopic ultrasound, or CT scanning.
- Cervical esophageal tumors,
- Gastric cancers with minor involvement of the gastroesophageal junction or distal esophagus.
- Prior chemotherapy or radiation.
- Patients with evidence of metastatic disease are not eligible. This includes:
- Positive malignant cytology of the pleura, pericardium or peritoneum.
- Radiographic evidence of distant organ involvement including lung, liver, bone, or brain.
- Patients with involvement of non-regional lymph nodes including supraclavicular or celiac lymph node metastases.
- Biopsy proven tumor invasion of the tracheobronchial tree or presence of tracheoesophageal fistula. Recurrent laryngeal nerve or phrenic nerve paralysis,
- New York Heart Association Class III or 1V heart disease. Angina or myocardial infarction within the last 6 months, history of significant ventricular arrhythmia requiring medication with antiarrhythmics, or a history of a clinically significant conduction system abnormality.
- Severe co-morbid conditions including severe uncontrolled diabetes, uncontrolled hypertension, cerebral vascular disease, uncontrolled infection, or nonmalignant illness whose control may be jeopardized by the complications of this study treatment.
- Pregnant or lactating women are ineligible as the effect of the drugs used in this study on a fetus or newborn child are unknown. Premenopausal fertile females require a negative pregnancy test prior to study entry. Treatment may not begin until the results of the pregnancy tests are ascertained. Both sexes must use contraception while on this study.
- History of prior malignancy (other than basal cell/squamous carcinoma of the skin, in-situ cervical carcinoma, or superficial transitional cell bladder carcinoma) diagnosed and/or treated within three years of entrance into this study.
- Patients with known Gilbert's Disease.
- Clinically significant hearing loss.
- Serum calcium_>12 mg/dl.
- Patients with a history of seizure disorder who are receiving phenytoin, phenobarbital, or other antiepileptic medication.
- Patients who cannot fully comprehend the therapeutic implications of the protocol or comply with the requirements.
- Patients with any other concurrent medical or psychiatric condition or disease, which, in the investigator's judgment, would make the patient inappropriate for entry into this study.
Sites / Locations
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
External Beam Radiation Therapy, Cisplatin, Irinotecan
Outcomes
Primary Outcome Measures
Pathologic Complete Response
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.
Secondary Outcome Measures
Evaluate Toxicity and Tolerability Including Surgical Morbidity and Mortality
Full Information
NCT ID
NCT00590031
First Posted
December 26, 2007
Last Updated
December 18, 2015
Sponsor
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00590031
Brief Title
Phase II Trial of Preoperative Combined Modality Therapy for Esophageal Carcinoma: Cisplatin-Irinotecan Followed by Radiation Therapy With Concurrent Cisplatin and Irinotecan.
Official Title
Preoperative Combined Modality Therapy for Esophageal Carcinoma: Cisplatin-Irinotecan Followed by Radiation Therapy With Concurrent Cisplatin and Irinotecan.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
4. Oversight
5. Study Description
Brief Summary
Patients with surgically resectable T1N1M0 or T2-4N any M0 esophageal carcinoma will receive six weeks of induction chemotherapy with weekly irinotecan and cisplatin given weeks 1, 2, 4 and 5. Patients will then receive weekly irinotecan, cisplatin, and concurrent radiotherapy with chemotherapy given once weekly, weeks 8,9,11 and 12 during the six weeks of radiotherapy. Patients will be referred for surgery 4-8 weeks after completion of chemoradiotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Carcinoma
Keywords
Esophageal Carcinoma, Cisplatin, Irinotecan, Radiation Therapy, 02-045
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
External Beam Radiation Therapy, Cisplatin, Irinotecan
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
pts will receive weekly cisplatin 30mg/m2 after hydration on weeks 8,9,11 and 12
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
Irinotecan will be given 65 mg/m2
Intervention Type
Radiation
Intervention Name(s)
External Beam Radiation Therapy
Intervention Description
will be delivered with multiple (>2) field techniques using mega-voltage radiation therapy. pts will receive 50.4 Gy and will be treated over a 6 week period.
Primary Outcome Measure Information:
Title
Pathologic Complete Response
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Evaluate Toxicity and Tolerability Including Surgical Morbidity and Mortality
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must be able to sign the informed consent document.
Exclusion Criteria:
Tis (in-situ carcinoma) and tumors determined to be TIN0 following endoscopy, endoscopic ultrasound, or CT scanning.
Cervical esophageal tumors,
Gastric cancers with minor involvement of the gastroesophageal junction or distal esophagus.
Prior chemotherapy or radiation.
Patients with evidence of metastatic disease are not eligible. This includes:
Positive malignant cytology of the pleura, pericardium or peritoneum.
Radiographic evidence of distant organ involvement including lung, liver, bone, or brain.
Patients with involvement of non-regional lymph nodes including supraclavicular or celiac lymph node metastases.
Biopsy proven tumor invasion of the tracheobronchial tree or presence of tracheoesophageal fistula. Recurrent laryngeal nerve or phrenic nerve paralysis,
New York Heart Association Class III or 1V heart disease. Angina or myocardial infarction within the last 6 months, history of significant ventricular arrhythmia requiring medication with antiarrhythmics, or a history of a clinically significant conduction system abnormality.
Severe co-morbid conditions including severe uncontrolled diabetes, uncontrolled hypertension, cerebral vascular disease, uncontrolled infection, or nonmalignant illness whose control may be jeopardized by the complications of this study treatment.
Pregnant or lactating women are ineligible as the effect of the drugs used in this study on a fetus or newborn child are unknown. Premenopausal fertile females require a negative pregnancy test prior to study entry. Treatment may not begin until the results of the pregnancy tests are ascertained. Both sexes must use contraception while on this study.
History of prior malignancy (other than basal cell/squamous carcinoma of the skin, in-situ cervical carcinoma, or superficial transitional cell bladder carcinoma) diagnosed and/or treated within three years of entrance into this study.
Patients with known Gilbert's Disease.
Clinically significant hearing loss.
Serum calcium_>12 mg/dl.
Patients with a history of seizure disorder who are receiving phenytoin, phenobarbital, or other antiepileptic medication.
Patients who cannot fully comprehend the therapeutic implications of the protocol or comply with the requirements.
Patients with any other concurrent medical or psychiatric condition or disease, which, in the investigator's judgment, would make the patient inappropriate for entry into this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Ilson, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan-Kettering Cancer Center
Learn more about this trial
Phase II Trial of Preoperative Combined Modality Therapy for Esophageal Carcinoma: Cisplatin-Irinotecan Followed by Radiation Therapy With Concurrent Cisplatin and Irinotecan.
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