Oxaliplatin-Based Chemotherapy and Chemoradiotherapy or Chemoradiotherapy in Esophageal or Gastroesophageal Carcinoma

This study has been completed.
Sponsor:
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
  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:

  1. 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
  2. Perform exploratory correlative studies on blood, adjacent normal and cancer tissue to assess predictive markers of response and outcome.
  3. 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:
  • 5-FU
  • Adrucil
  • Efudex
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:
  • RT
  • XRT
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:
  • 5-FU
  • Adrucil
  • Efudex
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:
  • RT
  • XRT
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:

  1. Local regional carcinoma of the thoracic esophagus (squamous cell or adeno) or gastroesophageal junction.
  2. Patients with T1N1, and T2-3 with any N (M1a only) will be eligible.
  3. 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).
  4. Performance status 0 or 1.
  5. Signed informed consent by the investigator or their designee and patient.
  6. Medically fit for surgery.
  7. No Celiac (except for the GE junction cancers), supraclavicular, or paraaortic nodal enlargement unless biopsy negative.
  8. None of the celiac nodes should be larger than 2 cm
  9. Male or Female but both sexes must practice adequate contraception while on therapy
  10. >/=18 years but less than 76 years
  11. No known allergy to any of the study drugs.
  12. No prior therapy for this cancer.
  13. No significant cancer (defined as non-melanomatous skin cancers and treated cervical cancers) within the past 5 years
  14. New York Heart Association (NYHA) I and II

Exclusion Criteria:

  1. Patients with T1N0, T4, or M1b cancer will be excluded
  2. Significant comorbid conditions (defined as uncontrolled diabetes, active angina or heart failure, uncontrolled hypertension, or active psychiatric condition that prevents consistent participation and compliance).
  3. More than grade 1 neuropathy
  4. Unable to comprehend the requirements of the study or comply with it.
  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: 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:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
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 September 30, 2014