Back to resultsPre-op Chemo-RT w/CDDP/5FU vs Chemo w/ Docetaxel/Irinotecan in PET Non Responder Resectable Esophagus Cancer
Primary Purpose
Carcinoma of Esophagus
Status
Terminated
Phase
Phase 2
Locations
Saudi Arabia
Study Type
Interventional
Intervention
irinotecan and docetaxel
Cisplatin, fluorouracil and concurrent radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma of Esophagus focused on measuring Randomized trial,, Pre-operative chemo-RT with CDDP and 5-FU, Multicenter study
Eligibility Criteria
Inclusion Criteria:
- Histologically proven squamous cell or adenocarcinoma of the thoracic esophagus and gastro-esophageal junction.
- No distant metastases.
- Signed written informed consent.
- Age less than 75 years.
- Potentially resectable tumor (radiological evidence of resection with no residual disease).
- ECOG 0 to 2.
- Normal serum creatinine and adequate hepatic function, serum bilirubin less than 30 mmol/l, serum alkaline phosphatase less than 2 times upper limit of normal and ALT and AST of less than 4 upper limits of normal.
- Normal bone marrow function with absolute neutrophile count of more than 1500/ml, hemoglobin more than 80 gm/L and platelets more than 100,000 /ml
Exclusion Criteria:
- Serious underlying medical condition which could impair the patient ability to participate in the clinical trial or comply to follow up
- Prior treatment with other anti cancer therapy or radiation therapy.
- Legal incapacity.
- Previous malignancy within 5 years except adequately treated non melanomatous skin cancer or in situ cervical cancer.
- Psychiatric or mental disorder precluding the understanding of the information of the trial topics and giving valid informed consent.
Sites / Locations
- King Faisal Specialist Hospital & Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Arm A
Arm B
Arm Description
Arm A: will receive combination of irinotecan and docetaxel regimen for 2 cycles, recycling every 21 days Irinotecan 100 mg/m2 by intra venous infusion over 2 hours in day1 and docetaxel 40 mg/m2 over one hour will be given on day 1 Assessment by PET scan and CT chest and abdomen will be done 2-3 weeks after end of 2nd cycle of irinotecan and docetaxel
Arm B will receive combination of cisplatin, fluorouracil and concurrent radiation therapy 50 Gy in 25 fractions over 5 weeks with cisplatin 75 mg/m2 on first day of week 1 and week 5 and fluorouracil 750 mg/m2 daily by continuous intra venous infusion at Day 1 and Day 29 of Radiation therapy for 4 days. PET scan will be repeated 3-4 weeks after end of concurrent chemo-radiation therapy Patients in Arm A and B will go for esophagectomy 4-6 weeks after end of concurrent chemo-radiation therapy or chemotherapy
Outcomes
Primary Outcome Measures
Pathological Complete Response ( regression score 1a- see response assessment) in each treatment group
Secondary Outcome Measures
Rate of conversion from PET non responder to responder with each type of salvage therapy
Failure Free Survival for each treatment group
Overall Survival for each treatment group
ERCC1 as a predictor of failure of response to cisplatin based chemotherapy in neo adjuvant setting.
Full Information
NCT ID
NCT01608464
First Posted
May 26, 2012
Last Updated
August 9, 2018
Sponsor
King Faisal Specialist Hospital & Research Center
1. Study Identification
Unique Protocol Identification Number
NCT01608464
Brief Title
Pre-op Chemo-RT w/CDDP/5FU vs Chemo w/ Docetaxel/Irinotecan in PET Non Responder Resectable Esophagus Cancer
Official Title
A Trial Comparing Pre-operative Chemo-radiotherapy With Cisplatin and Fluorouracil Versus Chemotherapy With Docetaxel and Irinotecan in PET Non Responders Resectable Cancer Esophagus: a Multicenter Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
poor accrual
Study Start Date
May 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King Faisal Specialist Hospital & Research Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to improve their outcome by either changing the chemotherapy drugs or giving them radiation therapy with concurrent chemotherapy, hoping that this will improve their outcome.
Detailed Description
This study is aimed at improving the outcome of resectable non PET responders, esophageal carcinoma, by either changing the chemotherapy drugs or giving them radiation therapy with concurrent chemotherapy, hoping that this will improve their outcome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma of Esophagus
Keywords
Randomized trial,, Pre-operative chemo-RT with CDDP and 5-FU, Multicenter study
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Active Comparator
Arm Description
Arm A: will receive combination of irinotecan and docetaxel regimen for 2 cycles, recycling every 21 days Irinotecan 100 mg/m2 by intra venous infusion over 2 hours in day1 and docetaxel 40 mg/m2 over one hour will be given on day 1 Assessment by PET scan and CT chest and abdomen will be done 2-3 weeks after end of 2nd cycle of irinotecan and docetaxel
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Arm B will receive combination of cisplatin, fluorouracil and concurrent radiation therapy 50 Gy in 25 fractions over 5 weeks with cisplatin 75 mg/m2 on first day of week 1 and week 5 and fluorouracil 750 mg/m2 daily by continuous intra venous infusion at Day 1 and Day 29 of Radiation therapy for 4 days.
PET scan will be repeated 3-4 weeks after end of concurrent chemo-radiation therapy Patients in Arm A and B will go for esophagectomy 4-6 weeks after end of concurrent chemo-radiation therapy or chemotherapy
Intervention Type
Drug
Intervention Name(s)
irinotecan and docetaxel
Other Intervention Name(s)
Irinotecan, Docetaxel
Intervention Description
combination of irinotecan and docetaxel regimen for 2 cycles, recycling every 21 days Irinotecan 100 mg/m2 by intra venous infusion over 2 hours in day1 and docetaxel 40 mg/m2 over one hour will be given on day 1 Assessment by PET scan and CT chest and abdomen will be done 2-3 weeks after end of 2nd cycle of irinotecan and docetaxel
Intervention Type
Drug
Intervention Name(s)
Cisplatin, fluorouracil and concurrent radiation therapy
Other Intervention Name(s)
Cisplatin, 5-FU, Concurrent RT with CDDP and 5-FU
Intervention Description
Cisplatin, fluorouracil and concurrent radiation therapy 50 Gy in 25 fractions over 5 weeks with cisplatin 75 mg/m2 on first day of week 1 and week 5 and fluorouracil 750 mg/m2 daily by continuous intra venous infusion at Day 1 and Day 29 of Radiation therapy for 4 days.
Primary Outcome Measure Information:
Title
Pathological Complete Response ( regression score 1a- see response assessment) in each treatment group
Time Frame
5 yrs
Secondary Outcome Measure Information:
Title
Rate of conversion from PET non responder to responder with each type of salvage therapy
Description
Failure Free Survival for each treatment group
Overall Survival for each treatment group
ERCC1 as a predictor of failure of response to cisplatin based chemotherapy in neo adjuvant setting.
Time Frame
5 yrs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically proven squamous cell or adenocarcinoma of the thoracic esophagus and gastro-esophageal junction.
No distant metastases.
Signed written informed consent.
Age less than 75 years.
Potentially resectable tumor (radiological evidence of resection with no residual disease).
ECOG 0 to 2.
Normal serum creatinine and adequate hepatic function, serum bilirubin less than 30 mmol/l, serum alkaline phosphatase less than 2 times upper limit of normal and ALT and AST of less than 4 upper limits of normal.
Normal bone marrow function with absolute neutrophile count of more than 1500/ml, hemoglobin more than 80 gm/L and platelets more than 100,000 /ml
Exclusion Criteria:
Serious underlying medical condition which could impair the patient ability to participate in the clinical trial or comply to follow up
Prior treatment with other anti cancer therapy or radiation therapy.
Legal incapacity.
Previous malignancy within 5 years except adequately treated non melanomatous skin cancer or in situ cervical cancer.
Psychiatric or mental disorder precluding the understanding of the information of the trial topics and giving valid informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shouki Bazarbashi, MD
Organizational Affiliation
King Faisal Specialist Hospital & Research Center, Riyadh, Saudi Arabia
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Faisal Specialist Hospital & Research Center
City
Riyadh
ZIP/Postal Code
11211
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Pre-op Chemo-RT w/CDDP/5FU vs Chemo w/ Docetaxel/Irinotecan in PET Non Responder Resectable Esophagus Cancer
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