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

NCT01608464 | Terminated Phase 2 DMC

• 1 other identifier: 2111-104
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma of Esophagus

Keywords

Randomized trial,; Pre-operative chemo-RT with CDDP and 5-FU; Multicenter study

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response ( regression score 1a- see response assessment) in each treatment group

  5 yrs

Secondary Outcomes (1)

• Rate of conversion from PET non responder to responder with each type of salvage therapy

  5 yrs

Study Arms (2)

Arm A

ACTIVE COMPARATOR

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

Arm B

EXPERIMENTAL

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

Interventions

irinotecan and docetaxel 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

Also known as: Irinotecan, Docetaxel

Arm A

Cisplatin, fluorouracil and concurrent radiation therapy 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.

Also known as: Cisplatin, 5-FU, Concurrent RT with CDDP and 5-FU

Arm B

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Study Sites (1)

King Faisal Specialist Hospital & Research Center

Riyadh, 11211, Saudi Arabia

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Irinotecan; Docetaxel; Cisplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Shouki Bazarbashi, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2012
• First Posted: May 31, 2012
• Study Start: May 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: August 10, 2018

Record last verified: 2017-10

Locations

SA (1)