S0356 Oxaliplatin, 5-FU, Radiation Therapy (RT), Surgery for Pts With Stage II or III Cancer of Esophagus or Gastroesophageal (GE) Junction
- Conditions
- Esophageal Cancer
- Interventions
- Registration Number
- NCT00086996
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Oxaliplatin and fluorouracil may make tumor cells more sensitive to radiation therapy and may kill more tumor cells. Giving chemotherapy and radiation therapy before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well giving oxaliplatin together with fluorouracil and radiation therapy works in treating patients who are undergoing surgery for stage II or stage III cancer of the esophagus or gastroesophageal junction.
- Detailed Description
OBJECTIVES:
Primary
* Determine the pathologic complete response probability in patients with stage II or III adenocarcinoma of the esophagus or gastroesophageal junction treated with neoadjuvant oxaliplatin, fluorouracil, and radiotherapy followed by definitive surgical resection.
Secondary
* Determine the frequency and severity of toxic effects associated with this neoadjuvant regimen in these patients.
* Determine the overall survival and progression-free survival of patients treated with this regimen.
Exploratory Analyses (subject to funding availability)
* Correlate, preliminarily, initial messenger ribonucleic acid (mRNA) levels of the genes for thymidylate synthase (TS), γ-glutamyl transpeptidase (γGT), γ-glutamyl cysteine (γ-GCS), DNA excision repair cross-complementing (ERCC-1), and xeroderma pigmentosum (XPA) with response and survival of patients treated with this regimen.
* Correlate, preliminarily, the mRNA levels of TS, γGT, γ-GCS, ERCC-1, and XPA before and after treatment with this regimen with survival of these patients.
* Correlate, preliminarily, specific genetic polymorphisms of TS and ERCC-1 with tumor response and overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
* Neoadjuvant chemoradiotherapy: Patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 and fluorouracil (5-FU) IV continuously on days 8-43. Beginning on day 8, patients also undergo radiotherapy once daily, 5 days a week, for 5 weeks.
* Surgery: Patients with stable disease or better undergo surgical resection 4-10 weeks after completion of chemoradiotherapy.
* Adjuvant chemotherapy: Beginning 4-10 weeks after surgery, patients receive chemotherapy comprising oxaliplatin IV over 2 hours on days 1, 15, and 29 and 5-FU IV continuously on days 1-36.
Treatment continues in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 45-85 patients will be accrued for this study within 17-21 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 98
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Chemo Plus RT, Surgery, Chemo fluorouracil neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin Chemo Plus RT, Surgery, Chemo oxaliplatin neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin Chemo Plus RT, Surgery, Chemo conventional surgery neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin Chemo Plus RT, Surgery, Chemo radiation therapy neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
- Primary Outcome Measures
Name Time Method Pathological Complete Response 10-16 weeks after beginning study treatment Complete pathologic response assessed after chemoradiotherapy and surgery, defined as no evidence of residual disease on path review. Patients who did not receive surgery are assumed to have not responded.
- Secondary Outcome Measures
Name Time Method Overall Survival 0-5 years Measured from time of registration to death, or last contact date
Progression-free Survival 0-3 years measured from date of registration to time of first documentation of progression by Response Evaluation Criteria in Solid Tumors (RECIST), death, or last contact date.
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Up to 3 years Only adverse events that are possibly, probably or definitely related to study drug are reported.
Trial Locations
- Locations (143)
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
Providence Cancer Center
🇺🇸Anchorage, Alaska, United States
Highlands Oncology Group - Springdale
🇺🇸Bentonville, Arkansas, United States
East Bay Radiation Oncology Center
🇺🇸Castro Valley, California, United States
Eden Medical Center
🇺🇸Castro Valley, California, United States
Valley Medical Oncology Consultants - Castro Valley
🇺🇸Castro Valley, California, United States
Valley Medical Oncology
🇺🇸Fremont, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Highland General Hospital
🇺🇸Oakland, California, United States
Alta Bates Summit Medical Center - Summit Campus
🇺🇸Oakland, California, United States
Scroll for more (133 remaining)Mobile Infirmary Medical Center🇺🇸Mobile, Alabama, United States