II-III기 직장암 치료를 위한 단기 방사선 요법 및 병용 화학 요법
국소적으로 진행된 직장 선암종 환자를 위한 장기 보존: FOLFOX 또는 CapeOX에 이은 단기 코스 방사선 요법의 효능 평가
This phase I trial investigates how well short-course radiation therapy followed by combination chemotherapy works in treating patients with stage II-III rectal cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as leucovorin, fluorouracil, oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving short-course radiation therapy and combination chemotherapy may reduce the need for surgery and therefore improve quality of life.
연구 개요
상태
정황
상세 설명
PRIMARY OBJECTIVE:
I. Complete clinical response (cCR) rate of patients with clinical T3 and/or node-positive M0 rectal cancer being treated with short-course radiation therapy (SCRT) followed by 16 weeks of modified leucovorin, fluorouracil, and oxaliplatin (mFOLFOX)/capecitabine and oxaliplatin (CapeOX).
SECONDARY OBJECTIVES:
I. 1-year local recurrence free survival and 1-year progression free survival of the entire cohort, the cohort that initially undergoes non-operative management (NOM), and the cohort that initially undergoes total mesorectal excision (TME).
II. Physician-reported acute and late >= grade 3 toxicity rates. III. 1-year post-treatment patient health-related quality of life and anorectal function as per Patient Reported Outcomes Measurement and Information System (PROMIS).
IV. Explore how Signatera's residual disease test correlates with patient's cCR rates, local recurrence, progression-free, and overall survival rates.
V. Explore radiomics features from longitudinal diffusion weighted magnetic resonance imaging (MRI) (diffusion weighted imaging [DWI]) data and build a predictive model for treatment effect (complete response) in rectal cancer patients undergoing SCRT.
OUTLINE:
Patients undergo SCRT in the form of intensity-modulated radiation therapy (IMRT) over 5 fractions daily for 5 consecutive days. Beginning 11-18 days after the last day of radiation therapy, patients receive either oxaliplatin intravenously (IV) and leucovorin IV on day 1 and fluorouracil IV on days 1-3 (mFOLFOX6) or oxaliplatin IV on day 1 and capecitabine orally (PO) twice daily (BID) on days 1-14 (CapeOX). Treatment with mFOLFOX6 repeats every 2 weeks for up to 8 cycles, and treatment with CapeOX repeats every 3 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. At 8-12 weeks after completion of all therapy, patients with residual tumor undergo TME. Patients with cCR undergo NOM.
After completion of study treatment, patients who underwent NOM are followed up every 3 months for 2 years, then every 6 months for 3 years. TME patients are followed up every 3-6 months for 2 years, then every 6 months for 3 years.
연구 유형
등록 (추정된)
단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Vincent Basehart
- 전화번호: 310 267-8954
- 이메일: vbasehart@mednet.ucla.edu
연구 장소
-
-
California
-
Los Angeles, California, 미국, 90095
- 모병
- UCLA / Jonsson Comprehensive Cancer Center
-
연락하다:
- Ann Raldow
- 전화번호: 310-825-9771
- 이메일: araldow@mednet.ucla.edu
-
수석 연구원:
- Ann Raldow
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Histologically confirmed rectal adenocarcinoma
- Patients must have stage II (cT3, cN0) or stage III (cT1-3, cN1-3) tumor as staged by MRI
- No evidence of metastatic disease
- Resectable primary lesion
- Karnofsky performance status (KPS) >= 70 or Eastern Cooperative Oncology Group (ECOG) 0-2
- Absolute neutrophil count (ANC) > 1.5 cell/mm^3
- Hemoglobin (Hgb) > 8.0 gm/dL
- Platelets (PLT) > 150,000/mm^3
- Total bilirubin < or equal to 1.5 x upper limit of normal
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < or equal to three times upper limit of normal
- If a woman is of childbearing potential, a negative serum pregnancy test must be documented prior to initiation of radiation therapy
Exclusion Criteria:
- Active treatment of a separate malignancy
- Distant metastatic disease as assessed by staging positron emission tomography (PET)/computed tomography (CT) or CT of the chest and abdomen within 6 weeks of starting radiation therapy
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- Pregnant and/or breastfeeding
- Medical/psychological contraindication to MRI
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: Treatment (IMRT, mFOLFOX6, CapeOX, TME)
Patients undergo SCRT in the form of IMRT over 5 fractions daily for 5 consecutive days. Beginning 11-18 days after the last day of radiation therapy, patients receive either oxaliplatin IV and leucovorin IV on day 1 and fluorouracil IV on days 1-3 (mFOLFOX6) or oxaliplatin IV on day 1 and capecitabine PO BID on days 1-14 (CapeOX). Treatment with mFOLFOX6 repeats every 2 weeks for up to 8 cycles, and treatment with CapeOX repeats every 3 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. At 8-12 weeks after completion of all therapy, patients with residual tumor undergo TME. Patients with cCR undergo NOM. |
Ancillary studies
다른 이름들:
Given IV
다른 이름들:
Given IV
다른 이름들:
Given IV
다른 이름들:
Undergo IMRT
다른 이름들:
Undergo TME
다른 이름들:
Given IV
다른 이름들:
Undergo NOM
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Complete clinical response rate
기간: Up to 5 years
|
Kaplan-Meier analysis will be carried out and used to estimate for the entire cohort as well the non-operational management (NOM) and total mesorectal excision (TME) cohorts separately. |
Up to 5 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Local recurrence-free survival
기간: At 1 year
|
Kaplan-Meier analysis will be carried out and used to estimate for the entire cohort as well the NOM and TME cohorts separately. |
At 1 year
|
|
Progression-free survival
기간: At 1 year
|
Kaplan-Meier analysis will be carried out and used to estimate for the entire cohort as well the NOM and TME cohorts separately. |
At 1 year
|
|
Incidence of adverse events
기간: Up to 5 years
|
Physician-reported acute and late >= grade 3 toxicity rates for the entire cohort will be graded according to Common Terminology Criteria for Adverse Events version 5.0. |
Up to 5 years
|
|
Health-related quality of life
기간: At 1 year
|
Will be assessed by Patient Reported Outcomes Measurement and Information System and calculated and presented as a composite score. These scores will be calculated for the entire cohort as well as the NOM and TME cohorts separately. |
At 1 year
|
|
Anorectal function
기간: At 1 year
|
Will be assessed by Patient Reported Outcomes Measurement and Information System and calculated and presented as a composite score. These scores will be calculated for the entire cohort as well as the NOM and TME cohorts separately. |
At 1 year
|
|
Signatera's residual disease test
기간: Up to 5 years
|
Cox proportional hazards regression analysis will be used to assess the association of circulating tumor deoxyribonucleic acid with clinical response rates, local recurrent, progression-free, and overall survival rates. |
Up to 5 years
|
|
Prediction of complete clinical response rate status by radiomics
기간: Up to 5 years
|
The relationship between complete clinical response as a binary variable and longitudinal radiomics features from a sequence of four diffusion weighted imaging data points will be assessed via a logistic regression model with a random effect term to account for within-subject correlation. |
Up to 5 years
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Ann Raldow, UCLA / Jonsson Comprehensive Cancer Center
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
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
- 부위별 신생물
- 신생물
- 장 질환
- 위장관 신생물
- 소화계 신생물
- 소화기계 질환
- 위장병
- 대장 신생물
- 장 신생물
- 직장 질환
- 직장 신생물
- 유기 화학 물질
- 이종 사이 클릭 화합물, 1- 링
- 이종 사이 클릭 화합물
- 이종 사이 클릭 화합물, 2- 링
- 이종 사이 클릭 화합물, 융합 링
- 치료학
- 핵산, 뉴클레오티드 및 뉴 클레오 시드
- 효소 및 코엔자임
- 조정 복합체
- 데 옥시 시티 딘
- 시티 딘
- 피리 미딘 뉴 클레오 시드
- 피리 미딘
- 뉴 클레오 시드
- Formyltetrahydrofolates
- 테트라 하이드로 폴 레이트
- 엽산
- Pterins
- Teridines
- 우라실
- 피리 미디 논
- 코엔자임
- 방사선 요법
- 데 옥시 리보 뉴 클레오 시드
- 방사선 요법, 적합성
- 방사선 요법, 컴퓨터 보조
- 카페시타빈
- 옥살리플라틴
- 플루오로우라실
- 류코보린
- 방사선 요법, 강도 조절
- Dehydroftorafur
기타 연구 ID 번호
- 20-001156
- 20-001156 (기타 식별자: UCLA / Jonsson Comprehensive Cancer Center)
- NCI-2020-06479 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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. .