Gemcitabine, Cisplatin, and Radiation Therapy Followed By Surgery or Surgery Alone in Treating Patients With Localized Pancreatic Cancer That Can Be Removed By Surgery
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|ClinicalTrials.gov Identifier: NCT00335543|
Recruitment Status : Completed
First Posted : June 12, 2006
Last Update Posted : August 12, 2013
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, 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 together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet know whether giving chemotherapy together with radiation therapy before surgery is more effective than surgery alone in treating pancreatic cancer.
PURPOSE: This randomized phase II trial is studying how well giving gemcitabine and cisplatin together with radiation therapy before surgery works compared to surgery alone in treating patients with localized pancreatic cancer that can be removed by surgery.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: cisplatin Drug: gemcitabine hydrochloride Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy||Phase 2|
- Determine whether neoadjuvant chemoradiotherapy comprising gemcitabine hydrochloride, cisplatin, and radiotherapy is better than immediate surgery, in terms of median survival, in patients with locally resectable adenocarcinoma of the pancreatic head.
- Compare 3-year survival rate in patients treated with these regimens.
- Compare R0 resection rate in these patients.
- Compare the rate of medium and high toxicity events in these patients.
- Compare the rate of complete and incomplete remission of the tumor as measured by radiographic imaging studies.
- Compare the rate of different regression gradings in resected tumor specimens.
- Compare the quality of life of these patients.
OUTLINE: This is a prospective, randomized, controlled, open-label, multicenter study. Patients are stratified according to participating center and staging laparoscopy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV over 1 hour on days 1, 8, 22, and 29. Patients also undergo radiotherapy to the tumor and surrounding lymph nodes 5 days a week for 5 weeks followed by 3 more doses of radiotherapy directly to the tumor. Approximately 6 weeks after finishing chemoradiotherapy, patients with no evidence of disease progression undergo surgery to remove the tumor.
- Arm II: Patients undergo surgery to remove the tumor. After surgery, all patients receive adjuvant chemotherapy comprising gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at the end of chemotherapy and before surgery (arm I), and then at 6 weeks, 6 months, 12 months, and 24 months after surgery.
After completion of study treatment, patients are followed every 3 months for 2 years and then at 3 years.
PROJECTED ACCRUAL: A total of 254 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||254 participants|
|Masking:||None (Open Label)|
|Official Title:||Preoperative Chemoradiation in Locally Resectable Adenocarcinoma of Pancreatic Head Without Metastasis|
|Study Start Date :||June 2003|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||October 2009|
- Median survival
- 3-year survival rate
- R0 resection rate
- Rate of medium and high toxicity events
- Rate of complete and incomplete remission of the tumor as measured by radiographic imaging studies
- Rate of different regression gradings in resected tumor specimens
- Quality of life before, during, and after therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00335543
|Study Chair:||W. Hohenberger, MD||Universitaet Erlangen|