- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01268384
Neoadjuvant FDR GX in Locally Advanced Pancreatic Cancer
Phase II Study of Fixed Dose Rate Gemcitabine Plus Capecitabine in Locally Advanced Pancreatic Cancer
The rationale for phase II trial of neoadjuvant fixed dose rate gemcitabine plus capecitabine for patients with LAPC includes the following: First, obtaining a sufficient tumor down-staging to procure R0/R1 resection, reported to be one of the most significant prognostic factors for survival; second, providing an observation period to exclude from surgery those patients with rapidly progressive disease there by to help select patients for surgery who have the greatest likelihood of a favorable postoperative outcome; third, eliminating micrometastatic disease, that is likely present in most patients, earlier than adjuvant setting and preventing post-surgical growth spurts; fourth, adjuvant therapy given in the neoadjuvant setting is better tolerated, as the patient has not recently undergone a major operation; and the last, the lack of widely accepted optimal preoperative or palliative approach in patients with LAPC, the majority of whom may not be operated on.
The primary goal is to determine the R0 resection rate of the neoadjuvant fixed dose rate (FDR) gemcitabine-capecitabine combination chemotherapy in patients with borderline resectable or unresectable locally advanced pancreatic adenocarcinoma.
The secondary goals are to assess progression-free survival (PFS) and OS (overall survival) in these patients and to assess adverse events of these neoadjuvant treatments.
연구 개요
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Seoul, 대한민국, 138-736
- Asan Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Histologically or cytologically documented pancreatic adenocarcinoma
- Clinical T3 or T4 tumor according to AJCC staging system
- Tumors considered as borderline resectable or unresectable disease assessed by multidisciplinary team including pancreatic surgeon, gastroenterologist specializing in pancreas, medical oncologist, and radiation oncologist
- Age 18 years or older
- ECOG performance status 2 or less
Adequate organ function
- Adequate bone marrow function (WBCs> 3,500/µL, absolute neutrophil count [ANC]> 1,500/µL, hemoglobin > 9.0 g/dL, and platelets > 100,000/µL)
- Adequate kidney function (creatinine < 1.5 mg/dL)
- Adequate liver function (bilirubin < 1.5 mg/dL [<2.5 mg/dL for patients with obstructive jaundice due to pancreatic cancer with adequate decompression], transaminases levels < 3 times the upper normal limit)
- Patients must not have psychological, familial, sociological or geographical conditions which do not permit medical follow-up and compliance with this study
- Women of childbearing potential must have a negative pregnancy test on admission. Post-menopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Men and women of reproductive potential must have agreed to use an effective method of contraception while on treatment and for 6 months after study treatment
- The patient must be able to understand the study and has given written informed consent to participate in the study
Exclusion Criteria:
- Other tumor type than adenocarcinoma
- Evidence of gastrointestinal bleeding or obstruction
- Presence of the clinically relevant ascites or distant metastases
- Past or concurrent history of malignant neoplasm, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
- Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- Hypersensitivity to any of the study drugs or ingredients
Other serious illness or medical conditions
- Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
- History of significant neurologic or psychiatric disorders including dementia or seizures
- Active uncontrolled infection
- Pre-existing clinically significant diarrhea
- Active peptic ulcer
- Severe hypercalcemia of 12 mg/dL uncontrolled with bisphosphonates
- Active disseminated intravascular coagulation
- Other serious underlying medical conditions which could impair the ability of the patient to participate in the study
- Concomitant or administration of any other experimental drug under investigation within 3 weeks before the study
- Concomitant chemotherapy, hormonal therapy, or immunotherapy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: FDR_GX
Fixed dose rate gemcitabine plus capecitabine every 3 weeks for 3-9 cycles
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Gemcitabine 1,250 mg/m2 mixed with 0.9% saline 500 ml i.v. for 10 mg/m2/min on D1 and D8 Capecitabine 950 mg/m2 b.i.d.
po from D1 to D14 every 21 days
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
R0 resection rate
기간: 6 months
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Microscopic complete resection rate after neoadjuvant chemotherapy
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6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Adverse events associated with neoadjuvant chemotherapy
기간: 6 months
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NCI CTCAE v.3.0 based AEs
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6 months
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Overall survival
기간: 2 years
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Overall survival after enrollment
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2 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jae-Lyun Lee, MD, PhD, Asan Medical Center
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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