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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by King Faisal Specialist Hospital & Research Center
Sponsor:
Information provided by (Responsible Party):
King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier:
NCT01608464
First received: May 26, 2012
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to improve their outcome by either changing the chemotherapy drugs or giving then radiation therapy with concurrent chemotherapy, hoping that this will improve their outcome.


Condition Intervention Phase
Carcinoma of Esophagus
Drug: irinotecan and docetaxel
Drug: Cisplatin, fluorouracil and concurrent radiation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by King Faisal Specialist Hospital & Research Center:

Primary Outcome Measures:
  • Pathological Complete Response ( regression score 1a- see response assessment) in each treatment group [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of conversion from PET non responder to responder with each type of salvage therapy [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]
    • 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.


Estimated Enrollment: 170
Study Start Date: May 2012
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
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
Other Names:
  • Irinotecan
  • Docetaxel
Experimental: 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

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.
Other Names:
  • Cisplatin
  • 5-FU
  • Concurrent RT with CDDP and 5-FU

  Eligibility

Ages Eligible for Study:   14 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01608464

Contacts
Contact: Shouki Bazarbashi, MD 966-1-4423799 bazarbashi@kfshrc.edu.sa
Contact: Fazal Hussain, MD 966-1-4423949 fhussain@kfshrc.edu.sa

Locations
Saudi Arabia
King Faisal Specialist Hospital & Research Center Recruiting
Riyadh, Saudi Arabia, 11211
Contact: Shouki Bazarbashi, MD    966-1-4423799    bazarbashi@gmail.com   
Contact: Fazal Hussain, MD    966-1-4423949    fhussain@kfshrc.edu.sa   
Principal Investigator: Shouki Bazarbashi, MD         
Sponsors and Collaborators
King Faisal Specialist Hospital & Research Center
Investigators
Principal Investigator: Shouki Bazarbashi, MD King Faisal Specialist Hospital & Research Center, Riyadh, Saudi Arabia
  More Information

No publications provided

Responsible Party: King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier: NCT01608464     History of Changes
Other Study ID Numbers: 2111-104
Study First Received: May 26, 2012
Last Updated: September 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by King Faisal Specialist Hospital & Research Center:
Randomized trial,
Pre-operative chemo-RT with CDDP and 5-FU
Multicenter study

Additional relevant MeSH terms:
Carcinoma
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Irinotecan
Docetaxel
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 24, 2014