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A Study of Bevacizumab (Avastin) in Participants With Newly Diagnosed Locally Advanced Rectal Cancer (INOVA)

2017년 7월 31일 업데이트: Hoffmann-La Roche

Efficacy and Safety of Two Neoadjuvant Strategies With Bevacizumab in Locally Advanced Resectable Rectal Cancer: A Randomized, Non-Comparative Phase II Study

This study will assess the efficacy and safety of two different neoadjuvant treatment approaches including bevacizumab in newly diagnosed participants with high risk locally advanced rectal cancer. Participants will be randomized into one of two treatment arms (Arm A or Arm B).

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

91

단계

  • 2 단계

연락처 및 위치

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

연구 장소

  • 프랑스
      • Angers, 프랑스, 49055
        • ICO Paul Papin; Oncologie Medicale.
      • Angers, 프랑스, 49055
      • Besancon, 프랑스, 25030
      • Besancon, 프랑스, 25030
        • HOPITAL JEAN MINJOZ; Oncologie
      • Bordeaux, 프랑스, 33075
      • Bordeaux, 프랑스, 33075
        • Hopital Saint Andre; Département de Radiothérapie Et D'Oncologie Médicale
      • Dijon, 프랑스, 21079
        • Centre Georges Francois Leclerc; Oncologie 3
      • Dijon, 프랑스, 21079
      • La Tronche, 프랑스, 38700
      • La Tronche, 프랑스, 38700
        • Hopital Albert Michallon; Radiotherapie
      • Lille, 프랑스, 59020
      • Lille, 프랑스, 59020
        • Centre Oscar Lambret; Radiotherapie
      • Montbeliard, 프랑스, 25209
      • Montbeliard, 프랑스, 25209
        • Centre Hospitalier Andre Boulloche; Departement D'Oncologie
      • Montpellier, 프랑스, 34928
      • Montpellier, 프랑스, 34928
        • Centre Val Aurelle Paul Lamarque; Radiotherapie
      • Nancy, 프랑스, 54100
      • Nancy, 프랑스, 54100
        • Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE
      • Nice, 프랑스, 06189
        • Centre Antoine Lacassagne; Hopital De Jour A2
      • Nice, 프랑스, 06189
      • Paris, 프랑스, 75970
        • HOPITAL TENON; Cancerologie Medicale
      • Paris, 프랑스, 75970
      • Paris, 프랑스, 75651
      • Paris, 프랑스, 75475
      • Paris, 프랑스, 75651
        • Ch Pitie Salpetriere; Oncologie Medicale
      • Paris, 프랑스, 75475
        • Hopital Saint Louis; Radiotherapie Oncologie
      • Pierre Benite, 프랑스, 69495
      • Pierre Benite, 프랑스, 69495
        • Ch Lyon Sud; Radiotherapie Sct Jules Courmont
      • Poitiers, 프랑스, 86021
      • Poitiers, 프랑스, 86021
        • Chu La Miletrie; Radiotherapie
      • Saint Herblain, 프랑스, 44805
        • Ico Rene Gauducheau; Oncologie
      • Saint Herblain, 프랑스, 44805
      • Strasbourg, 프랑스, 67065
        • Centre Paul Strauss; Oncologie Medicale
      • Strasbourg, 프랑스, 67065
      • Toulouse, 프랑스, 31078
      • Toulouse, 프랑스, 31078
        • Polyclinique Du Parc; Centre De Hautes Energies
      • Tours, 프랑스, 37044
      • Tours, 프랑스, 37044
        • Hopital Bretonneau; Clinique D'Oncologie & de Radiotherapie
      • Vandoeuvre Les Nancy, 프랑스, 54511
      • Vandoeuvre Les Nancy, 프랑스, 54511
        • Centre Alexis Vautrin; Oncologie Medicale

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 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • histologically confirmed locally advanced rectal cancer;
  • measurable disease;
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

Exclusion Criteria:

  • prior treatment with bevacizumab;
  • prior radiotherapy to pelvic region, or previous cytotoxic chemotherapy;
  • previous history of malignancy (other than basal and squamous cell cancer of the skin, or in situ cancer of the cervix);
  • history or evidence of central nervous system (CNS) disease;
  • clinically significant cardiovascular disease;
  • chronic treatment with high dose aspirin (more than [>] 325 milligrams per day [mg/day]) or non-steroidal anti-inflammatory drugs.

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
실험적: Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)
In this arm, participants will undergo 3 phases of treatment. During the Phase 1, participants will receive induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 will include 7 weeks of bevacizumab + chemoradiotherapy (intravenous [IV] infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 will be surgery involving a radical rectal excision using the total mesorectal excision (TME) technique.
의약품: Bevacizumab
Bevacizumab will be administered at the fixed dose of 5 milligrams per kilogram (mg/kg) as an IV infusion over 30 to 90 minutes.
다른 이름들:
  • 아바스틴
의약품: Oxaliplatin
Oxaliplatin will be administered at a dose of 85 milligrams per square meter (mg/m^2) as a 2-hour IV infusion.
의약품: Folinic Acid
Folinic acid will be administered at a dose of 200 mg/m^2 as a 2-hour infusion.
의약품: 5-fluorouracil
5-fluorouracil will be administered at a dose of 400 mg/m^2 as an IV bolus, then at a dose of 600 mg/m^2 as a continuous infusion for 22 hours in Phase 1, and will be administered at a dose of 225 mg/m^2 as a 24-hour infusion, 5 days a week, for 5 weeks in Phase 2.
방사능: Preoperative Radiotherapy
Radiotherapy will be delivered in fraction of 1.8 gray per day (Gy/day), 5 days a week for 5 weeks, i.e., a total dose of 45 Gy will be administered in 25 fractions over a period of 33 days.
절차: Surgery
Radical rectal excision based on the TME technique.
실험적: Arm B (Bevacizumab, Chemoradiotherapy)
In this arm, participants will receive the Phase 2 and Phase 3 treatments only. The phase 2 will include 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 will be surgery involving a radical rectal excision using the TME technique.
의약품: Bevacizumab
Bevacizumab will be administered at the fixed dose of 5 milligrams per kilogram (mg/kg) as an IV infusion over 30 to 90 minutes.
다른 이름들:
  • 아바스틴
의약품: 5-fluorouracil
5-fluorouracil will be administered at a dose of 400 mg/m^2 as an IV bolus, then at a dose of 600 mg/m^2 as a continuous infusion for 22 hours in Phase 1, and will be administered at a dose of 225 mg/m^2 as a 24-hour infusion, 5 days a week, for 5 weeks in Phase 2.
방사능: Preoperative Radiotherapy
Radiotherapy will be delivered in fraction of 1.8 gray per day (Gy/day), 5 days a week for 5 weeks, i.e., a total dose of 45 Gy will be administered in 25 fractions over a period of 33 days.
절차: Surgery
Radical rectal excision based on the TME technique.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants With Tumor Sterilization Defined by ypT0-N0
기간: After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)
Tumor sterilization was defined as the absence of residual tumor cells in the resected specimen including lymph nodes (ypT0-N0). The rate of sterilization of the tumoral specimen was assessed after surgery on the surgical specimen by local review. Analyses were performed for participants who have been operated as defined by the protocol (within the study and TME technique) and for all participants who have been operated. Reported is the percentage of participants with tumor sterilization.
After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants With Tumor Down-Staging (ypT0-pT2)
기간: After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)
A participant with a downstaging was defined as a participant with T3 (T describes the size of the original [primary] tumor) at inclusion and T2 or T1 or T0 after surgery, or with N+ (N describes lymph nodes involvement) at inclusion and N- after surgery and if T is equal at inclusion and after surgery. The clinical tumor-node-metastasis (cTNM) classification was used at inclusion and the pathological staging tumor and nodes (ypTN) classification after surgery. Reported is the percentage of participants with tumor downstaging of the surgical specimen according to the local review and centralized review.
After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)
Percentage of Participants With Local and Distant Recurrences
기간: After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)
The percentage of participants with a recurrence was described by type of recurrence (local and distant recurrence).
After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)
Percentage of Participants With Second Cancer, Local or Regional Recurrence, Distant Metastasis, or Death
기간: Baseline up to approximately 6 years
Baseline up to approximately 6 years
Disease-Free Survival (DFS)
기간: From first time of the treatment administration to the date of second cancer, local or regional recurrence, distant metastasis or death from any cause (up to approximately 6 years)
The DFS was defined as the time from the first treatment intake to disease recurrence assessed (second primary cancer, local or distant recurrence, distant metastases) or death from any cause. The DFS was analyzed using Kaplan-Meier method.
From first time of the treatment administration to the date of second cancer, local or regional recurrence, distant metastasis or death from any cause (up to approximately 6 years)
Percentage of Participants Who Died
기간: Baseline up to approximately 6 years
Baseline up to approximately 6 years
Overall Survival
기간: From the first treatment administration to the date of death (up to approximately 6 years)
The overall survival was defined as the time from the first treatment intake to death from any cause.
From the first treatment administration to the date of death (up to approximately 6 years)
Number of Cycles of Induction Chemotherapy
기간: 6 cycles (12 weeks; cycle length = 14 days)
6 cycles (12 weeks; cycle length = 14 days)
Number of Cycles of Chemotherapy
기간: Arm A: Week 16 to Week 23; Arm B: Week 1 to Week 7
Arm A: Week 16 to Week 23; Arm B: Week 1 to Week 7
Number of Cycles of Radiotherapy
기간: Arm A: Week 16 to Week 23; Arm B: Week 1 to Week 7
Arm A: Week 16 to Week 23; Arm B: Week 1 to Week 7
Percentage of Participants With Surgery
기간: Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment
The surgery involving a radical rectal excision using the TME technique.
Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Hoffmann-La Roche

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

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 (실제)

2007년 10월 23일

기본 완료 (실제)

2016년 3월 23일

연구 완료 (실제)

2016년 3월 23일

연구 등록 날짜

최초 제출

2009년 3월 18일

QC 기준을 충족하는 최초 제출

2009년 3월 18일

처음 게시됨 (추정)

2009년 3월 19일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 8월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 7월 31일

마지막으로 확인됨

2017년 7월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • ML19202
  • 2006-003472-35 (EudraCT 번호)

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. .

직장암에 대한 임상 시험

Bevacizumab에 대한 임상 시험

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스폰서 및 공동 작업자

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약물 개입

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약물 개입

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스폰서 / 협력자

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