Clinical trial NCT00711412
Conditions: Esophageal Cancer
Keywords: adenocarcinoma of the esophagus stage I esophageal cancer stage II esophageal cancer stage III esophageal cancer stage IV esophageal cancer
Sponsor: Northwestern University
Start date: 2006-05-31; Completion date: 2013-01-30
Enrollment: 44 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
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.

Detailed description:
OBJECTIVES:

Primary

* Determine the pathologic complete response in patients with adenocarcinoma of the esophagus or gastroesophageal junction treated with neoadjuvant therapy comprising capecitabine, oxaliplatin, and radiotherapy.

Secondary

* 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.

OUTLINE:

* 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.

Arms: arm 1: Weeks 1-6:

Capecitabine 1000mg/m2 twice daily Oxaliplatin 70mg/m2 on days 1 and 8

Weeks 7-12:

Capecitabine 825 mg/m2 twice daily Oxaliplatin 50mg/m2 weekly Radiation 1.8 Gy Monday-Friday

Evaluation for response and resection surgery
Interventions: intervention 1: Induction Therapy - Capecitabine intervention 2: Induction Therapy - Oxaliplatin intervention 3: Combination Therapy - Capecitabine intervention 4: Combination Therapy - Oxaliplatin intervention 5: Combination Therapy - Radiation intervention 6: Evaluation for response and surgery
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: 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. intervention 4: 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. intervention 5: 1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy. intervention 6: Four to eight weeks following the completion of therapy subjects will undergo evaluation for response and surgical resection.

Protocol documents: