Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Esophageal or Gastroesophageal Junction Cancer
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin together with radiation therapy works in treating patients with esophageal or gastroesophageal junction cancer.
|Esophageal Cancer||Drug: Capecitabine - Induction Therapy Drug: Oxaliplatin - Induction Therapy Drug: Capcitabine - Combination Therapy Drug: Oxaliplatin - Combination Therapy Radiation: Radiation - Combination Therapy||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Capecitabine and Oxaliplatin With Radiation for Esophageal and Gastroesophageal Junction Adenocarcinoma|
- Pathologic complete response [ Time Frame: At time of surgery ]
- Clinical response rate [ Time Frame: Following chemotherapy treatment and prior to surgery ]
- Recurrence rate [ Time Frame: At the time of disease recurrence or death ]
- Time to progression [ Time Frame: At the time of progression of disease ]
- Patterns of failure [ Time Frame: At time of surgery ]
- Toxicity profile [ Time Frame: During chemotherapy and up to 30 days post-last dose of chemotherapy ]
|Study Start Date:||October 2005|
|Estimated Study Completion Date:||February 2019|
|Estimated Primary Completion Date:||February 2018 (Final data collection date for primary outcome measure)|
Experimental: Capecitabine, Oxaliplatin
Capecitabine 1000mg/m2 twice daily Oxaliplatin 70mg/m2 on days 1 and 8
Drug: Capecitabine - Induction Therapy
Two 21-day cycles will be given as induction. Capecitabine will be given at 1000 mg/m2 twice daily approximately 12 hours apart for 14 days, followed by seven days off.Drug: Oxaliplatin - Induction Therapy
Two 21-day cycles will be given as induction. Oxaliplatin will be given at 70 mg/m2 intravenously in 5% dextrose over two hours on days 1 and 8 of each cycle.
Experimental: Capecitabine, Oxaliplatin, Radiation
Capecitabine 825 mg/m2 twice daily Oxaliplatin 50mg/m2 weekly Radiation 1.8 Gy Monday-Friday
Drug: Capcitabine - Combination Therapy
Two 21-day cycles will be given for combination therapy. Capecitabine will be given at 825 mg/m2 twice daily approximately 12 hours apart for five days (Monday through Friday) followed by two days off for 51/2 weeks.Drug: Oxaliplatin - Combination Therapy
Two 21-day cycles will be given. Oxaliplatin will be given at 50 mg/m2 intravenously in 5% dextrose over two hours on days 1, 8 and 15 of each cycle.Radiation: Radiation - Combination Therapy
1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy.
- Determine the pathologic complete response in patients with adenocarcinoma of the esophagus or gastroesophageal junction treated with neoadjuvant therapy comprising capecitabine, oxaliplatin, and radiotherapy.
- Determine the clinical response rate in patients treated with this regimen.
- Determine the recurrence rate, time to progression, and patterns of failure in patients treated with this regimen.
- Characterize the toxicity profile of this regimen in these patients.
- Induction therapy: Patients receive oral capecitabine twice daily on days 1-14 and oxaliplatin IV over 2 hours on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
- Combination chemoradiotherapy: Patients then receive oxaliplatin IV over 2 hours once weekly for 6 weeks. Patients also receive concurrent oral capecitabine twice daily and undergo radiotherapy once daily 5 days a week for 5½ weeks in the absence of disease progression or unacceptable toxicity.
- Surgery: Patients undergo surgical resection at 4-8 weeks after completion of chemoradiotherapy.
After completion of study treatment, patients are followed every 3 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00711412
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|Principal Investigator:||Mary Mulcahy, MD||Robert H. Lurie Cancer Center|