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

Carcinoma of Esophagus Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01608464
• Other study ID #: 2111-104
• Status: Terminated
• Phase: Phase 2
• Start date: May 2012
• Est. completion date: September 2015

Study information

• Verified date: October 2017
• Source: King Faisal Specialist Hospital & Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 170
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma of Esophagus
• Esophageal Neoplasms

Intervention

Drug:
• 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
• 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.

Locations

Country	Name	City	State
Saudi Arabia	King Faisal Specialist Hospital & Research Center	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Faisal Specialist Hospital & Research Center

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological Complete Response ( regression score 1a- see response assessment) in each treatment group		5 yrs
Secondary	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.	5 yrs