- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00994721
A Phase III Study of Pancreatic Cancer
A Randomized Phase III Study of Adjuvant Gemcitabine Versus Gemcitabine Plus Concurrent Chemoradiation in Pancreatic Cancer Underwent Curative Intent (R0 / R1) Resection
Study Design: Adjuvant gemcitabine therapy has been shown to improve recurrence-free survival in pancreatic cancer underwent curative intent resection. This study is to evaluate whether combining concurrent chemo-radiotherapy can further improve the recurrence-free survival benefit of adjuvant gemcitabine chemotherapy in pancreatic cancer underwent curative resection.
Research Objective and Study End Points
- Primary endpoint: The primary end point is disease free survival.
- Secondary endpoints: The secondary end points are to evaluate the overall survival, local and distant recurrence rate, and impact on quality of life after adjuvant gemcitabine with or without CCRT in curatively resected pancreatic cancer.
Furthermore, the clinical, pathological and molecular prognostic factors in curatively resected pancreatic cancers will be evaluated.
연구 개요
상태
정황
상세 설명
Treatment plan and Randomization scheme::
Patients will be randomized after stratification according to pathology report on section margin, tumor size, lymph node metastasis:
Patients who are randomized to Arm 1 will receive adjuvant chemotherapy started within 4-8 weeks after the surgery, and administered at D1, D8 and D15 every 4 weeks for 6 cycles (6 months). Patients who are allocated to Arm 2 will receive sandwich treatment, which comprised of the same adjuvant chemotherapy within 4-8 weeks after the surgery for 3 cycles (3 months), followed by CCRT (start 4-6 weeks after the last dose of 3rd cycle chemotherapy) and then another 3 cycles of gemcitabine monotherapy.
Statistical Consideration:
We anticipate the 2-year disease free survival will increase from 25% to 40% with the incorporation of CCRT into the adjuvant treatment for post-operative pancreatic adenocarcinoma. With a significant level of 0.05, 107 patients will be required for each treatment arm to reach 80% statistical power. Since the drop out rate is approximately 10%, 265 patients will be enrolled to ensure that we will have 214 (107x2) eligible patients in this study. We anticipate that we will recruit roughly 67 patients per year, therefore, patient recruitment will be completed in 4 years.
Randomization scheme:
Histo-/cyto-logically confirmed macroscopic complete resected pancreatic adenocarcinoma
- The primary end-point is disease free survival.
- The secondary end-points are overall survival; local and distant control rate, and the quality of life.
The clinical and molecular prognostic factors for overall survival.
- Radiation fields encompass initial main tumor of pancreas only with a safe margin of 1cm. Lymph node regions initially involved with tumor confirmed by excision will be included in the clinical target volume. Elective radiation to uninvolved lymph nodes will not be given.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Taipei, 대만
- Mackay Memorial Hospital
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Taipei, 대만
- National Taiwan University Hospital
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Taipei, 대만
- Chang-Gung Memorial Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
A.Eligibility Criteria
- Patients with pancreatic cancer after curative intent resection.
- The histology of resected tumor has to be adenocarcinoma.
- Age 20-75 years.
- ECOG performance scale 0-1.
- Patients must have normal organ and marrow function as defined below.
- The effects of study agents on the developing human fetus at the recommended therapeutic dose are unknown.
- to sign a written informed consent.
- Registered within 6 weeks after surgery.
- Preoperative abdominal CT or MRI with contrast enhancement.
B.Exclusion Criteria
- Patients with gross residual, macroscopic positive resection margin or distant metastases.
- Patients may not be receiving any other investigational agents.
- Patients who have had prior chemotherapy or radiotherapy are not eligible.
- History of allergic reactions.
- Patients who had non-curable second primary malignancy.
- Uncontrolled intercurrent illness including.
- Pregnant women.
- receiving immuno-suppressive therapy、anti-coagulants.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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pancreatic cancer
resected pancreatic cancer
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
The primary end-point is recurrence-free survival.
기간: Pancreatic Cancer Disease Committee
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Pancreatic Cancer Disease Committee
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2차 결과 측정
결과 측정 |
기간 |
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The secondary end-points are overall survival; local and distant control rate, and the quality of life.
기간: Pancreatic Cancer Disease Committee
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Pancreatic Cancer Disease Committee
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Yu-Lin Lin, M.D., National Taiwan University Hospital
- 연구 의자: Tsann-Long Hwang, M.D., Chang Gung Memorial Hospital
- 수석 연구원: Yu-Wen Tien Tien, Ph.D., National Taiwan University Hospital
- 수석 연구원: Yi-Ming Shyr, M.D., Taipei Veterans General Hospital, Taiwan
- 수석 연구원: Pin-Wen Lin, M.D, National Cheng-Kung University Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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