Genotype-directed Neoadjuvant Chemoradiation for Rectal Carcinoma
연구 개요
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Missouri
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Saint Louis, Missouri, 미국, 63110
- Washington University School of Medicine
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Biopsy proven adenocarcinoma of the rectum
- Lesion evaluated by surgeon and found to be resectable
- Stage T3 or T4 disease on radiography or ultrasound
- Karnofsky Performance Status at >60
Laboratory criteria:
- Absolute neutrophil count >= 1.5 K
- Platelets >= 100 K
- Total Bilirubin <= 2.0;
- SGOT and Alkaline Phosphatase <= 2 x upper limit of normal
- Creatinine < 2.0
- Informed consent signed
- Patients with distant metastatic disease will be eligible if they satisfy all other conditions.
Exclusion Criteria:
- Pregnant women, children < 18 years, or patients unable to give informed consent
- Patients with a past history of pelvic radiotherapy.
- Patients with prior malignancy in the past 5 years except: skin cancer or in-situ cervical cancer. However, patients with synchronous adenocarcinomas are eligible provided either (a) the synchronous adenocarcinoma was in a removed pedunculated polyp and did not invade the stalk or (b) the synchronous adenocarcinoma was in a removed polyp that lay within the surgical field (extent of resection would not be changed) or (c) the synchronous adenocarcinoma is smaller than the index rectal cancer and lies completely within the radiation field (clinically favorable second lesion and the extend of radiation and surgery would not be changed).
- Patients with known allergy to 5-fluorouracil or irinotecan
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4)
Radiation 45 Gy in 25 fractions to the pelvis. 5FU CIVI 225 mg/m2/day by CIVI during radiation Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable. |
다른 이름들:
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실험적: Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4)
Radiation 45 Gy in 25 fractions to the pelvis. 5FU CIVI 225 mg/m2/day by CIVI during radiation Irinotecan 50 mg/m2 IV weekly for 5 doses. Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable. |
다른 이름들:
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Rate of Tumor Downstaging Compared With Historical Controls.
기간: 1 year after enrollment
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Tumor downstaging (DS) is defined as a decrease in the T stage of the primary tumor by at least 1. Historical studies demonstrate a DS rate of 45%. |
1 year after enrollment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Complete Response Rates
기간: 1 year after enrollment
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Complete tumor response is defined as the absence of any viable tumor in the rectum (ypT0). Pathologic complete response (pCR) is defined as the absence of any viable tumor in the rectum or in the perirectal lymph nodes (ypT0N0). pCR rate of historical controls is 8%-14%. |
1 year after enrollment
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Define Patient Quality of Life Prior to and Following Neoadjuvant Chemoradiation.
기간: Prior to start of study treatment and 3-6 weeks post completion of radiation therapy
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The questionnaire is encouraged but not required.
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Prior to start of study treatment and 3-6 weeks post completion of radiation therapy
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Determine Patient Fears and Expectations of Pharmacogenetics.
기간: Prior to start of study treatment and 3-6 weeks post completion of radiation therapy
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The questionnaire is encouraged but not required.
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Prior to start of study treatment and 3-6 weeks post completion of radiation therapy
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공동 작업자 및 조사자
간행물 및 유용한 링크
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 02-0561
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