Oxaliplatin-Based Chemotherapy and Chemoradiotherapy or Chemoradiotherapy in Esophageal or Gastroesophageal Carcinoma
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Sanofi
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00525915
First received: September 4, 2007
Last updated: April 1, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The goal of this clinical research study is to learn if a combination of the investigational drug oxaliplatin with 5-Fluorouracil (5-FU) (given at the same time as radiation therapy) is as effective as a combination of these two drugs given before and during radiation therapy in the treatment of esophageal or gastroesophageal cancers. The safety of these combinations of therapy will also be compared.
Objectives:
Primary objective:
Compare the Pathologic Complete Response rate and % of patients with <50% residual cancer in the resected surgical specimen between Arms A and B.
Secondary objectives:
- Compare 1-year and 3-year survival rates, median survival time, R0 resection rates, safety, and local plus systemic relapse rates between Arms A and B
- Perform exploratory correlative studies on blood, adjacent normal and cancer tissue to assess predictive markers of response and outcome.
- Evaluate the joint effects, including possible interactive effects, of proton-versus-photon therapy and treatment arm on overall survival, R0 resection rates, safety, and local plus systemic relapse rates.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer Gastroesophageal Cancer |
Drug: 5-Fluorouracil Drug: Oxaliplatin Radiation: Radiation Therapy Procedure: Surgery |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Oxaliplatin-Based Phase II Randomized Study of Induction Chemotherapy Followed by Preoperative Chemoradiotherapy or Preoperative Chemoradiotherapy in Patients With Resectable Esophageal or Gastroesophageal Carcinoma |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Patient Responses [ Time Frame: Surgery post chemotherapy (approximately 10-11 weeks) ] [ Designated as safety issue: No ]Pathologic Complete Response rate (pathCR rate) Once surgery performed, response to therapy judged in surgical specimen with three possible categories 1) Pathologic complete response (no residual cancer in the specimen); 2) <50% of residual cells in the surgical specimen; or 3) >50% of cells in the surgical specimen.
| Enrollment: | 126 |
| Study Start Date: | April 2005 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm A: Chemo with Radiation Treatment
For 5 weeks, Chemo of 5-FU 250 mg/m^2 intravenous (IV) over 24 hours for 5 days weekly with Oxaliplatin 40 mg/m^2 IV daily over 2 hours, and Radiation treatment every weekday; then surgery.
|
Drug: 5-Fluorouracil
Arm A = 250 mg/m^2 IV over 24 hours for 5 days weekly for 5 weeks. Arm B = 2.2 mg/m^2 IV over 48 hours on days 1 and 15. Other Names:
Drug: Oxaliplatin
Arm A: 40 mg/m^2 IV daily over 2 hours for 5 weeks Arm B: 100 mg/m^2 IV on Day 1 and 15 Other Name: Eloxatin
Radiation: Radiation Therapy
Radiation treatment every weekday for 5 weeks.
Other Names:
Procedure: Surgery
Surgical removal of the primary tumor and lymph nodes following completion of disease status evaluation post chemotherapy and radiation treatments.
|
|
Experimental: Arm B: Pre-Op Chemo + Chemo with Radiation Treatment
Pre-Operative Chemo 5-FU 2.2 mg/m^2 IV continuous infusion over 48 hours start on day 1 and 15, and Oxaliplatin 100 mg/m^2 IV on day 1 and 15; followed by Surgery + Chemo with Radiation Therapy (same as Arm A)
|
Drug: 5-Fluorouracil
Arm A = 250 mg/m^2 IV over 24 hours for 5 days weekly for 5 weeks. Arm B = 2.2 mg/m^2 IV over 48 hours on days 1 and 15. Other Names:
Drug: Oxaliplatin
Arm A: 40 mg/m^2 IV daily over 2 hours for 5 weeks Arm B: 100 mg/m^2 IV on Day 1 and 15 Other Name: Eloxatin
Radiation: Radiation Therapy
Radiation treatment every weekday for 5 weeks.
Other Names:
Procedure: Surgery
Surgical removal of the primary tumor and lymph nodes following completion of disease status evaluation post chemotherapy and radiation treatments.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 76 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Local regional carcinoma of the thoracic esophagus (squamous cell or adeno) or gastroesophageal junction.
- Patients with T1N1, and T2-3 with any N (M1a only) will be eligible.
- Normal liver (serum glutamic-pyruvic transaminase (SGPT) < 56µL, Total Bilirubin <1.5 mg/dL), kidney (Creatinine <1.75 mg/dL), and bone marrow functions (AGN >1,500µL, platelet count >100,000/µL).
- Performance status 0 or 1.
- Signed informed consent by the investigator or their designee and patient.
- Medically fit for surgery.
- No Celiac (except for the GE junction cancers), supraclavicular, or paraaortic nodal enlargement unless biopsy negative.
- None of the celiac nodes should be larger than 2 cm
- Male or Female but both sexes must practice adequate contraception while on therapy
- >/=18 years but less than 76 years
- No known allergy to any of the study drugs.
- No prior therapy for this cancer.
- No significant cancer (defined as non-melanomatous skin cancers and treated cervical cancers) within the past 5 years
- New York Heart Association (NYHA) I and II
Exclusion Criteria:
- Patients with T1N0, T4, or M1b cancer will be excluded
- Significant comorbid conditions (defined as uncontrolled diabetes, active angina or heart failure, uncontrolled hypertension, or active psychiatric condition that prevents consistent participation and compliance).
- More than grade 1 neuropathy
- Unable to comprehend the requirements of the study or comply with it.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00525915
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Sanofi
Investigators
| Principal Investigator: | Jaffer Ajani, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00525915 History of Changes |
| Other Study ID Numbers: | 2004-0703 |
| Study First Received: | September 4, 2007 |
| Last Updated: | April 1, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
Esophageal Cancer Gastroesophageal Cancer Gastroesophageal Junction Radiation Therapy 5-Fluorouracil |
5-FU Adrucil Efudex Oxaliplatin |
Additional relevant MeSH terms:
|
Carcinoma Esophageal Diseases Esophageal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Head and Neck Neoplasms |
Fluorouracil Oxaliplatin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013