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Neo-adjuvant Chemoradiation With Oxaliplatin/5-FU in Rectal Cancer

2018년 2월 20일 업데이트: Beth Israel Medical Center

A Phase II Open-labeled, Prospective Study to Determine the Efficacy of Preoperative Chemoradiation With Oxaliplatin/5-FU in Locally Advanced Rectal Cancer Followed by Total Mesorectal Excision and FOLFOX6

RATIONALE: 5FU based neoadjuvant chemoradiation (nCRT) is the standard of care for Stage II/III rectal cancer. Pathologic complete response (pCR) and downstaging have been associated with improved outcomes. The addition of oxaliplatin (OXA) to neoadjuvant therapy may reduce distant disease recurrence. Adjuvant treatment with OXA for rectal cancer has been motivated by benefits demonstrated in stage III colon cancer.

Objective: To determine the feasibility, toxicity, and efficacy of preoperative OXA/5FU and RT followed by total mesorectal excision (TME) and adjuvant

PURPOSE: This phase II trial is studying the side effects and how well giving neo-adjuvant combination chemotherapy with radiation works in treating patients undergoing surgery for rectal cancer.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

OBJECTIVES:

Primary

  • To assess the complete pathologic response rate in patients with rectal cancer treated with radiation, modified neoadjuvant FOLFOX 6 chemotherapy followed by total mesorectal excision and adjuvant modified FOLFOX 6 chemotherapy.

Secondary

  • To observe the overall pathologic response rate in these patients.
  • To correlate pathologic staging with preoperative ultrasound and pelvic MRI staging.
  • To assess toxic side effects of these regimens in these patients.
  • To assess patterns of disease relapse, disease-free survival outcomes, and overall survival outcomes of these patients.

OUTLINE:

Patients with stage II/III rectal cancer were treated with OXA 60mg/m2 weekly continuous infusion 5FU of 225 mg/m2/d d1-5 with pelvic RT of 1.8Gy/d for 28 doses. Adjuvant therapy consisted of 6 cycles of biweekly FOLFOX6.

Surgery: Patients undergo total mesorectal excision by anterior resection or an abdominal perineal resection within 4 weeks after completion of neoadjuvant therapy.

Adjuvant therapy: Within 4 weeks after surgery, patients receive modified FOLFOX 6 chemotherapy comprising oxaliplatin and leucovorin calcium IV over 2 hours on day 1 and continuous fluorouracil IV over 46 hours on days 1-2. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients complete quality of life assessment questionnaires at baseline and at each follow-up visit.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and annually thereafter.

연구 유형

중재적

등록 (실제)

27

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • New York
      • New York, New York, 미국, 10019
        • St. Luke's-Roosevelt Hospital Center - Roosevelt Division
      • New York, New York, 미국, 10003
        • Beth Israel Medical Center - Philipps Ambulatory Care Center

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

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria

  • Histologically proven adenocarcinoma of the rectum with no distant metastases.
  • T3-4N0M0, TanyN1-3M0 assessed by clinical exam, TRUS, MRI and CT
  • The distal border of the tumor must be at or below the peritoneal reflection, defined as within 12 centimeters of the anal verge by protoscopic examination.
  • No prior chemotherapy or pelvic irradiation.
  • ECOG performance status 0-1
  • Age 18 to 70 years
  • ANC >= 1500/mm3 and platelets >= 100,000/mm3
  • Serum creatinine <= 1.5 x ULN; bilirubin <= 1.5 x ULN; ALT<= 2.5 x ULN

Exclusion Criteria

  • Pregnant or lactating females; patients not practicing active contraception while sexually active.
  • No other serious medical condition
  • A psychiatric disorder that would prohibit the subject from participating fully.
  • Peripheral neuropathy > grade 1
  • History within the past 5 years of a cancer diagnosis except for non-melanomatous skin cancers or in situ cervix carcinoma.
  • HIV positive patients

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: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Preoperative Chemoradiation
Preoperative Chemoradiation with oxaliplatin/5-FU followed by mesorectal excision and 5-FU / leucovorin (FOLFOX 6)
의약품: 5-FU
5-FU: continuous infusion via portable pump during all RT (approximately 33 days)
다른 이름들:
  • 플루오로우라실
의약품: Oxaliplatin
Oxaliplatin: 50mg/m2 weekly dosing during RT (Day 1)
다른 이름들:
  • 엘록사틴
의약품: leucovorin
Folinic Acid (Leucovorin): 400 mg/m2; 2-hour IV infusion simultaneously with oxaliplatin
다른 이름들:
  • 엽산
절차: mesorectal excision
mesorectal excision

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Pathologic Response and Complete Response
기간: Total mesorectal excision (TME) participants were evaluated at the time of surgical resection, an average of 3.5 months

Pathologic Response and Complete Response to preoperative therapy will be determined at the time of surgical resection. All grossly visible areas of ulceration and/or induration with be measured and submitted for histological evaluation.

The unit of measure is the tumor response rate to preoperative chemoradiation.

Pathologic complete response (pCR) is defined as no evidence of invasive tumor cells on pathologic examination of the primary rectal cancer.

Tumor regression grade (TRG) will be quantitated into five grades:

TRG 1 (complete regression) -absence of residual cancer and fibrosis extending from the site of original tumor through the layers of the rectal wall.

TRG 2 characterized by the presence of rare residual cancer cells scattered through the fibrosis.

TRG 3 characterized by an increase in the number of residual cancer cells, but fibrosis still predominant.

TRG 4 -residual cancer outgrowing fibrosis. TRG 5 characterized by absence of regressive changes.
Total mesorectal excision (TME) participants were evaluated at the time of surgical resection, an average of 3.5 months

2차 결과 측정

결과 측정
측정값 설명
기간
Treatment Toxicity
기간: Weekly during chemoradiation treatment (3 months). Bi-weekly during adjuvant FOLFOX therapy (3.5 months).
Toxicity was assessed weekly during neoadjuvant chemotherapy and radiation therapy, bi-weekly during adjuvant FOLFOX therapy.
Weekly during chemoradiation treatment (3 months). Bi-weekly during adjuvant FOLFOX therapy (3.5 months).
Complete Resectability Rates
기간: Total mesorectal excision (TME) participants were evaluated at the time of surgical resection, 3 months after beginning of chemoradiation treatment.
Complete resectability rates assessed by circumferential margin.
Total mesorectal excision (TME) participants were evaluated at the time of surgical resection, 3 months after beginning of chemoradiation treatment.
Local Regional Control
기간: median follow-up 22 months post-TME
subjects were followed for median of 22 months post-surgery
median follow-up 22 months post-TME
Disease-free Survival
기간: median 22 months follow-up
median 22 months follow-up
Overall Survival
기간: median follow-up 22 months
median follow-up 22 months
Patterns of Disease Failure, Including Local Recurrence and Distant Metastasis Assessed by CT Scan
기간: median follow-up 22 months
median follow-up 22 months
Number of Participants With Comparison of Preoperative Stage With Post-treatment Pathologic Stage
기간: Total mesorectal excision (TME) participants were evaluated at the time of surgical resection, 3 months after beginning of chemoradiation treatment.
Thin-section high resolution pelvic MRI was used to image the tumor prior to chemoradiation and repeated prior to surgery, and then compared to post-treatment pathological stage.
Total mesorectal excision (TME) participants were evaluated at the time of surgical resection, 3 months after beginning of chemoradiation treatment.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Beth Israel Medical Center

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

2004년 7월 1일

기본 완료 (실제)

2009년 11월 1일

연구 완료 (실제)

2009년 11월 1일

연구 등록 날짜

최초 제출

2009년 1월 27일

QC 기준을 충족하는 최초 제출

2009년 1월 27일

처음 게시됨 (추정)

2009년 1월 28일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 3월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 2월 20일

마지막으로 확인됨

2018년 2월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CDR0000633360
  • BIMCP-OX-08-006 (레지스트리 식별자: BIMCP-OX-08-006)
  • AVENTIS-BIMCP-OX-08-006 (기타 보조금/기금 번호: AVENTIS-BIMCP-OX-08-006)

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. .

대장암에 대한 임상 시험

5-FU에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Tunisia

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
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