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

King Faisal Specialist Hospital & Research Center

Status and phase: Terminated; Phase 2

Conditions: Carcinoma of Esophagus

Treatments: Drug: irinotecan and docetaxel; Drug: Cisplatin, fluorouracil and concurrent radiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01608464

2111-104

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 patients

Sex: All

Ages: 14 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

170 participants in 2 patient groups

Arm A

Active Comparator group

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

Treatment:

Drug: irinotecan and docetaxel

Arm B

Experimental group

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

Treatment:

Drug: Cisplatin, fluorouracil and concurrent radiation therapy