- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00160875
Pre-operative Chemo (CPT11, Cisplatin), Radiotherapy, Plus Surgery for Resectable Esophageal Cancer
A Phase II Study to Assess the Efficacy of Combined Pre-operative Chemo (CPT11, Cisplatin), Radiotherapy (External Beam, Brachytherapy), Plus Surgery for Potentially Resectable Thoracic Esophageal Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Historical surgical series have reported that the chance of cure with surgery alone is approximately one in four. Many phase II studies and some phase III studies have examined the role of induction (preoperative) chemotherapy and radiation. In general, these studies have demonstrated a trend to improved survival using an induction regimen with one phase III study reporting a significant improvement in survival. Two meta-analyses have failed to demonstrate a clear advantage of an induction regimen.
When these trials are reviewed, it is apparent that there is a subgroup of patients who are found at the time of resection to have had a complete pathological response to their treatment, and these patients clearly experience improved survival.
These previous trials have used older chemotherapy agents. Nevertheless, cisplatin remains one of the most active drugs available for treating solid tumours. Irinotecan is a newer drug that has demonstrated significant activity in colorectal cancer and more recently in esophageal cancer. A previous single institution trial of cisplatin and irinotecan in esophageal cancer demonstrated a significant response and acceptable toxicity.
By giving one cycle of chemotherapy alone first, it is expected that the dysphagia usually experienced by these patients will improve sufficiently and that nutritional support, i.e. feeding tube, will not be required (as has been demonstrated in a previous study of this drug combination). The same drugs will then be given concurrently with external beam radiation in order to take advantage of the radiosensitizing properties of both these drugs.
This will be followed by a boost dose of radiation, which will provide a total dose in the tumourcidal range. Surgery will follow the boost dose of radiation.
This study proposes to combine two drugs with demonstrated activity in esophageal cancer, cisplatin and Irinotecan, with radiation prior to surgery, with the hypothesis that these more active agents will offer better control of distant metastatic disease. Their radiosensitizing properties, when combined with radiation, will improve local control and provide an increased rate of pathological complete response in patients with surgically resectable esophageal cancer.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2M9
- University Health Network
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically proven squamous or adenocarcinoma or the esophagus >20 cm from the incisors, including GE junction tumors (unless of gastric origin). GE junction tumors are defined as tumors that have their center within 5 cm proximal and distal of the anatomical cardia
- Clinical T1 N1 M0, T2-3 N0-1 M0, T1-3 N0-1 M1a
- Performance status ECOG 0-2
- Medically fit for chemotherapy, radiation and esophagectomy
- Adequate bone marrow, hepatic and renal function as evidenced by the following:
Hematology:
Neutrophils > 1.5 x 109/L Platelets > 100 x 109/L
Hepatic function:
Total bilirubin < 1.25x ULN AST (SGOT) and ALT (SGPT) < 2.5 x ULN Alkaline phosphatase <2.5 x ULN
Renal function:
Serum creatinine < 160 umol/L or creatinine clearance > 60 ml/min (actual or calculated by the Cockcroft-Gault method as follows):
weight (kg) x (140 - age) K x serum creatinine*
for serum creatinine in *mol/L, K=0.814 in man, K=0.96 in woman
- No prior history of malignancy unless > 5 years disease free, or adequately treated nonmelanotic skin cancer or in situ carcinoma of the cervix
- Tumor technically resectable (as defined in Section 5.4.3)
Exclusion Criteria:
- In situ or clinical T1N0M0
- Cervical esophageal tumors (within 20 cm of the incisors)
- Positive cytology of the pleura, peritoneum or pericardium
- Supraclavicular lymph node involvement
- Invasion of tracheobronchial tree proven by bronchoscopy including but not limited to tracheo-esophageal fistula
- Prior treatment for this malignancy except esophageal stenting
- Gilbert's disease
- Age < 18
- Participation in another concurrent clinical study involving study drug(s) or treatment with study drug within thirty days prior to the treatment on this study. Concurrent treatment with other experimental drugs or anticancer therapy
- Known hypersensitivity to either of study drugs or to any of their excipients.
- Pregnant or lactating women. Men and women of reproductive potential (and women < 12 months after menopause) may not participate unless they have agreed to use an effective contraceptive method while on study
- Known or suspected alcohol or drug abuse
- Other serious or concurrent illnesses that may interfere with subject compliance, adequate informed consent, determination of causality of adverse events and which in the judgement of the Investigator, would make the patient inappropriate for entry into the study
- Life expectancy < 3 months
- Peripheral neuropathy > Grade 2 (using CTC Version 2)
- Patients receiving phenytoin or phenobarbital
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cisplatin, Irinotecan
|
Irinotecan (65mg/m2) weeks 1-2, 4-5, 7-8
Cisplatin (30 mg/m2) weeks 1-2, 4-5, 7-8
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pathological complete response
Time Frame: 1 day
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
acute and late toxicities
Time Frame: 5 yrs
|
5 yrs
|
postoperative mortality
Time Frame: 1 month
|
1 month
|
disease free survival
Time Frame: 5 yrs
|
5 yrs
|
overall survival
Time Frame: 5 yrs
|
5 yrs
|
Quality of life (FACT-E)
Time Frame: 5 yrs
|
5 yrs
|
clinical complete response rate
Time Frame: 2 months
|
2 months
|
tumor microvessel density (pathological)
Time Frame: 1 day
|
1 day
|
perfusion CT parameters (radiological)
Time Frame: 2 months
|
2 months
|
PET scan parameters (radiological)
Time Frame: 2 months
|
2 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Darling E Gail, M.D., FRCSC, University Health Network, Toronto
- Principal Investigator: Knox J Jennifer, MD,MSc,FRCPC, University Health Network, Toronto
- Principal Investigator: Wong KS Rebecca, MSC, FRCSC, University Health Network, Toronto
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Esophageal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Cisplatin
- Irinotecan
Other Study ID Numbers
- 02-0484-C
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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