Pre-op Chemo-RT w/CDDP/5FU vs Chemo w/ Docetaxel/Irinotecan in PET Non Responder Resectable Esophagus Cancer

NCT ID: NCT01608464

Last Updated: 2018-08-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2015-09-30

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.

Conditions

Carcinoma of Esophagus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Arm A

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

Group Type: ACTIVE_COMPARATOR

irinotecan and docetaxel

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Cisplatin, fluorouracil and concurrent radiation therapy

Intervention Type: DRUG

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.

Interventions

irinotecan and docetaxel

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

Cisplatin, fluorouracil and concurrent radiation therapy

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.

Intervention Type: DRUG

Other Intervention Names

Irinotecan; Docetaxel; Cisplatin; 5-FU; Concurrent RT with CDDP and 5-FU

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

1. Serious underlying medical condition which could impair the patient ability to participate in the clinical trial or comply to follow up

2. Prior treatment with other anti cancer therapy or radiation therapy.

3. Legal incapacity.

4. Previous malignancy within 5 years except adequately treated non melanomatous skin cancer or in situ cervical cancer.

5. Psychiatric or mental disorder precluding the understanding of the information of the trial topics and giving valid informed consent.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Faisal Specialist Hospital & Research Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shouki Bazarbashi, MD

Role: PRINCIPAL_INVESTIGATOR

King Faisal Specialist Hospital & Research Center, Riyadh, Saudi Arabia

Locations

King Faisal Specialist Hospital & Research Center

Riyadh, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

2111-104

Identifier Type: -

Identifier Source: org_study_id