Preoperative Chemoradiation Followed by Chemotherapy for Locally Advanced Rectal Cancer (PREPARE)
2017년 9월 12일 업데이트: Sun Young Kim, National Cancer Center, Korea
A Randomized Phase II Trial of Preoperative Chemoradiation (Preop CRT) Followed by CapOx (Capecitabine Plus Oxaliplatin) Versus Preop CRT Alone for Locally Advanced Rectal Cancer (LARC)
The current standard treatment of locally advanced rectal cancer (clinical stage II or III) is preoperative radiation with chemotherapy (CRT) followed by surgery.
But this approach can be suboptimal for patients with high risk features (more deeply-seated tumor or many regional lymph nodes involved)that are associated with recurrence.
This study test a hypothesis that CRT followed by chemotherapy before surgery can improve efficacy of preoperative treatment.
연구 개요
상태
알려지지 않은
상세 설명
Downstaging rate with CRT using fluoropyrimidine monotherapy is usually 30-40%.In MRI-defined high-risk patients, downstaging rate with conventional fluoropyrimidine-based monotherapy with radiation has not been shown.
We assume that the downstaging rate of chemoradiation arm (control arm) would be 30%, and that addition of CapOx after CRT (experimental arm) may increase downstaging rate 30% to 50%.
A sample size of 52 patients per group is needed have 85% power to detect downstaging rate = 50% as compared to 30% with type I error rate of 15%.
We will perform one interim futility analysis when half of the patients are recruited and evaluated for the primary endpoint.
O'Brien-Fleming boundary will be considered.
Therefore, when 26 patients per arm are evaluated, the interim futility analysis will be performed, and when the Z score at the interim is less than -0.09192 (one-sided p-value greater than 0.5366192), the study will be stopped for futility.
Considering 5% follow-up loss, a sample size of 55 per arm (a total of 110 patients) will be studied.
연구 유형
중재적
등록 (실제)
110
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Anyang, 대한민국
- Hallym University Sacred Heart Hospital
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Gangneung, 대한민국
- Gangneung Asan Hospital
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Seoul, 대한민국, 03722
- Severance Hospital
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Seoul, 대한민국, 05505
- Asan Medical Center
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Seoul, 대한민국, 06973
- Chung-Ang University Hospital
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Gyeonggi-do
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Goyang, Gyeonggi-do, 대한민국, 410-769
- National Cancer Center
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Seongnam, Gyeonggi-do, 대한민국, 13620
- Seoul National University Bundang Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
20년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- histologically confirmed adenocarcinoma of the rectum
- distal margin of tumor located from 0 to 12 cm from anal verge measured by digital rectal examination
high risk clinical stage II or III in MRI (satisfying at least one of the followings)
- circumferential resection margin < 1 mm involved
- low-lying tumor below anal verge 3 cm
- T3 > 5 mm extramural spread
- T4 (involving surrounding structures or peritoneum)
- cN2 (4 or more mixed signal intensity or irregularly bordered node or tumor deposit)
- age 20 years or more
- ECOG (Eastern Cooperative Oncology Group) performance status 0-2
- No prior chemotherapy, radiotherapy to pelvis
- Adequate bone marrow function
- Adequate renal function
- Adequate hepatic function
- patients must sign the informed consent indicating that they were aware of the investigational nature of the study in keeping with the policy of the hospital
Exclusion Criteria:
- malignant disease of the rectum other than adenocarcinoma or arisen from chronic inflammatory bowel disease
- any unresected synchronous colon cancer
- any distant metastases
- intestinal obstruction or impending obstruction, but decompressing colostomy is permitted
- any previous or concurrent malignancy withih 5 years other than non-melanoma skin cancer / in situ cancer of uterine cervix / early gastric cancer / thyroid cancer of low risk
- any other morbidity or situation with relative contraindication for chemoradiotherapy
- patients with history of significant gastric or small bowel resection, or malabsorption syndrome, or other lack of integrity of the upper gastrointestinal tract that may compromise the absorption of capecitabine
- pregnant or lactating women or patients of childbearing potential not predicting adequate contraception
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: chemoradiation followed by CapOx
preoperative chemoradiation 50.4Gy with capecitabine or 5-fluorouracil/leucovorin (pelvic radiation capecitabine 5-fluorouracil) followed by 2 cycles of chemotherapy (Capecitabine Oxaliplatin - CapOx) and surgery (total mesorectal excision)
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after completion of chemoradiation, two cycles of capecitabine (850mg/m2 twice daily from D1 evening to D15 morning) and oxaliplatin (100mg/m2 on D1) will be administered every 3 weeks.
다른 이름들:
50.4Gy of pelvic radiation with capecitabine or 5-fluorouracil
다른 이름들:
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활성 비교기: chemoradiation
preoperative chemoradiation 50.4Gy with capecitabine or 5-fluorouracil/leucovorin (pelvic radiation capecitabine 5-fluorouracil) followed by rest for 8 weeks and surgery (total mesorectal excision)
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50.4Gy of pelvic radiation with capecitabine or 5-fluorouracil
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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downstaging rate
기간: expected average of 15 weeks after start of study treatment
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downstaging rate is defined as the proportion of patients with ypStage (pathologic stage after preoperative treatment) 0 or I (from pathologic findings after preoperative treatment and surgery) out of all patients who were assigned to each arm.
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expected average of 15 weeks after start of study treatment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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pathologic response
기간: expected average of 15 weeks after start of study treatment
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pathologic response is assessed by Dworak's grading system from postoperative specimen.
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expected average of 15 weeks after start of study treatment
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radiologic response rate
기간: expected average of 14 weeks after start of study treatment
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radiologic response will be assessed according to RECIST (Response Evaluation Criteria in Solid Tumors) guideline 1.1
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expected average of 14 weeks after start of study treatment
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toxicity profile
기간: expected average of 35 weeks after start of study treatment
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Toxicities or any adverse events during study treatment, surgery and follow-up period will be assessed according to NCI CTCAE (Common Terminology Criteria for Adverse Events) version 4.0
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expected average of 35 weeks after start of study treatment
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pattern of failure
기간: 3 years after surgery
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if any recurrent lesion is noticed, anatomic sites of recurrent lesions and the date and the name of exam or imaging study (physical exam, CT or MRI…) will be recorded in case report form.
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3 years after surgery
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local control rate
기간: 3 years after surgery
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Local recurrence is defined as tumor recurrence confined in radiation field (pelvic cavity).
Cumulative incidence of local recurrence will be suggested.
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3 years after surgery
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relapse-free survival
기간: 3 years after surgery
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Time from date of operation to date of recurrence of disease or deaths due to recurrence or progression of disease.
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3 years after surgery
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Disease-free survival
기간: 3 years after surgery
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time from date of operation to date of recurrence of disease, a new occurrence of secondary colorectal cancer, a new occurrence of other malignancy, or deaths from any cause.
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3 years after surgery
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overall survival
기간: 3 years after surgery
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time from date of operation to date of death due to any cause.
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3 years after surgery
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quality of life
기간: before study treatment, 7 weeks after completion of chemoradiation, and at 4 weeks after surgery
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quality of life will be measured with FACT-C
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before study treatment, 7 weeks after completion of chemoradiation, and at 4 weeks after surgery
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Sun Young Kim, MD, Asan Medical Center
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2014년 6월 1일
기본 완료 (실제)
2017년 9월 1일
연구 완료 (예상)
2019년 12월 1일
연구 등록 날짜
최초 제출
2013년 9월 11일
QC 기준을 충족하는 최초 제출
2013년 9월 25일
처음 게시됨 (추정)
2013년 9월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 9월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 9월 12일
마지막으로 확인됨
2017년 9월 1일
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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