Clinical trial NCT00268437
Conditions: Esophageal Cancer
Keywords: adenocarcinoma of the esophagus squamous cell carcinoma of the esophagus stage III esophageal cancer stage II esophageal cancer
Sponsor: Alliance for Clinical Trials in Oncology
Start date: 2006-04-01; Completion date: 2015-03-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as pemetrexed disodium and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving radiation therapy together with pemetrexed disodium and carboplatin 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 radiation therapy together with pemetrexed disodium and carboplatin works in treating patients with locally advanced esophageal cancer that can be removed by surgery.

Detailed description:
OBJECTIVES:

Primary

\* Determine the pathologic complete response rate of radiotherapy, pemetrexed disodium, and carboplatin when administered prior to esophagectomy in patients with locally advanced esophageal cancer.

Secondary

* Determine the activity, in terms of clinical response rate and adverse event profile of radiotherapy, pemetrexed disodium, and carboplatin when administered prior to esophagectomy.
* Determine the overall survival, time-to-progression, and time-to-treatment failure for patients receiving the above combined modality treatment.
* Determine the surgical outcome for all patients who undergo esophagectomy.
* Determine the time-to-disease recurrence and disease-free survival for patients who have a curative resection.
* Determine quality of life of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients undergo radiotherapy once daily, 5 days a week, for 5 ½ weeks and concurrently receive pemetrexed disodium IV over 10 minutes and carboplatin IV over 30 minutes on days 1 and 22. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients who are eligible will undergo esophagectomy between 4-12 weeks after completion of radiotherapy.

Quality of life is assessed at baseline, immediately prior to day 22 of chemotherapy, and within 2 weeks prior to surgery.

After completion of study treatment, patients are followed periodically for approximately 4 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Arms: arm 1: Pemetrexed+Carboplatin+Radiation
Interventions: intervention 1: carboplatin intervention 2: Pemetrexed intervention 3: conventional surgery intervention 4: neoadjuvant therapy intervention 5: radiation therapy
Intervention descriptions: intervention 1: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment. intervention 2: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment. intervention 3: None intervention 4: None intervention 5: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).

Protocol documents: