Radiation Therapy, Pemetrexed Disodium, and Carboplatin in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed By Surgery
|ClinicalTrials.gov Identifier: NCT00268437|
Recruitment Status : Terminated (Trial closed early because, during an interim analysis, the primary endpoint fell short.)
First Posted : December 22, 2005
Results First Posted : March 27, 2015
Last Update Posted : July 6, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer||Drug: carboplatin Drug: Pemetrexed Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy||Phase 2|
* Determine the pathologic complete response rate of radiotherapy, pemetrexed disodium, and carboplatin when administered prior to esophagectomy in patients with locally advanced esophageal cancer.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Preoperative Radiation and Chemotherapy (Pemetrexed and Carboplatin) for Locally Advanced Esophageal Cancer|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||March 2015|
carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.Drug: Pemetrexed
Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy
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).
- Pathologic Complete Response Rate [ Time Frame: Baseline to time of surgery (around 10 - 18 weeks post-baseline) ]The proportion of pathologic complete responses will be estimated by the number of pathologic complete responses divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true pathologic complete response rate will be calculated. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for Measurable disease is defined as at least one lesion whose longest diameter can be accurately measured as ≥2.0 cm with conventional techniques or as ≥1.0 cm with spiral CT. Lesions on chest x-ray are acceptable as measurable lesions when they are clearly defined and surrounded by aerated lung. However, CT is preferable.
- Overall Survival [ Time Frame: From baseline to 4 years ]Time from registration to death due to any cause.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00268437
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|Study Chair:||Aminah Jatoi, MD||Mayo Clinic|