Concurrent Chemoradiation With Concomitant Boost In Locally Advanced Rectal Cancer
2016년 3월 29일 업데이트: Lorenzo Fuccio, IRCCS Azienda Ospedaliero-Universitaria di Bologna
Concurrent Chemoradiation With Concomitant Boost In Locally Advanced Rectal Cancer: A Phase II Study.
Neoadjuvant chemoradiation (CRT), is considered the standard treatment of locally advanced rectal cancer with a positive impact on locoregional control and survival.However, patients with T4 rectal cancer show high risk of local recurrence after conventional treatment.
Therefore investigators designed a prospective Phase II study on patients with locally advanced rectal cancer or locally recurrences, to evaluate the efficacy in terms of pathological response and resectability of concomitant boost RT (55 Gy/5 weeks) with concurrent Raltitrexed and Oxaliplatin (Tom-Ox) chemotherapy.
연구 개요
상세 설명
Neoadjuvant chemoradiation (CRT), is considered the standard treatment of locally advanced rectal cancer with a positive impact on locoregional control and survival.
However, patients with T4 rectal cancer show high risk of local recurrence (LR) after conventional treatment.
This was a prospective Phase II study on patients with locally advanced rectal cancer or locally recurrences, to evaluate the efficacy in terms of pathological response and resectability of concomitant boost RT (55 Gy/5 weeks) with concurrent Raltitrexed and Oxaliplatin (Tom-Ox) chemotherapy.
The primary aim was to assess the pathological complete response rate.
Key secondary aim was the resectability.
Secondary aims were evaluation of treatment-related acute and late toxicity, local control, disease-free survival and overall survival (OS).
The follow-up period of each subjects started after the radiochemotherapy treatment and ended after a maximum of 36 months of observation or until death.
연구 유형
중재적
등록 (실제)
18
단계
- 2 단계
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 locally advanced (T4N0-2) or locally recurrent rectal adenocarcinoma;
- Age ≥ 18 years;
- Eastern Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Exclusion Criteria:
- Metastatic patients
- unfit surgery patients,
- pregnant or breast feeding females
- patients with clinically detectable ascites
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 |
|---|---|
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실험적: Radiotherapy plus Tom-Ox
Patients received concomitant boost RT (55 Gy/5 weeks) with concurrent Tom-Ox chemotherapy.
The concurrent chemotherapy consisted of 15 min intravenous infusion Raltitrexed (Tomudex ®) 3 mg/m2 and a two-hours intravenous infusion of Oxaliplatin (Eloxatin ®) at 130 mg/m 2, 20 min after raltitrexed, on days 1, 17, 35.
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Radiotherapy was applied as conformal 3-D technique and was delivered with photon energies of 10 - 15 MV.
The beams were delivered by an Elekta Precise Linac equipped with standard multi leaf collimators (MLC).
A daily online check of isocenter position was performed using portal imaging, with set-up correction in case of displacement > 0.5 cm in any direction.
Radiation dose delivered to PTV2 was 45 Gy (1.8 Gy/fraction) with a concomitant boost dose to the PTV1 of 10 Gy with accelerated fractionation at 2.2 Gy/fraction, five consecutive days for week.
The concurrent chemotherapy consisted of 15 min intravenous infusion Raltitrexed (Tomudex ®) 3 mg/m2 and a two-hours intravenous infusion of Oxaliplatin (Eloxatin ®) at 130 mg/m 2, 20 min after raltitrexed, on days 1, 17, 35.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of patients defined as good responders (G1 or G2) according to the Mandard regression grading system.
기간: 8 weeks after chemo-radiotherapy
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Pathologic responses of the primary tumours were defined according to the Mandard regression grading system: grade 1 was recorded when no tumour cells remained in the primary tumour and lymph nodes (pCR); grade 2 was characterized by the presence of rare residual cancer cells scattered through the fibrosis; grade 3 was characterized by an increase in the number of residual cancer cells, but fibrosis still predominated; grade 4 showed residual cancer outgrowing fibrosis; and grade 5 was characterized by an absence of regressive changes.
Good responders were defined those patients with a pathologic response with Mandard G1 or G2 and poor responder patients with Mandard G3, G4 or G5.
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8 weeks after chemo-radiotherapy
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of patients in which a surgical resection was feasible
기간: 8 weeks after chemo-radiotherapy
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8 weeks after chemo-radiotherapy
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Number of participants with treatment-related adverse events as assessed by CTCAE v3.0
기간: Up to 36 months. In details, follow-up examinations were performed 4 weeks after surgery and every 6 months until the established length of follow-up or death.
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CTCAE v 3.0 was used to score acute and late radiation toxicity.
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Up to 36 months. In details, follow-up examinations were performed 4 weeks after surgery and every 6 months until the established length of follow-up or death.
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The number of patients without disease (i.e. rectal cancer) during the follow-up.
기간: Up to 36 months.
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The disease-free survival (DFS) was defined as the time from the diagnosis to the documented local or distant recurrence or last follow-up.
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Up to 36 months.
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The number of patients still alive at the end of follow-up
기간: Up to 36 months
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The overall-survival (OS) was defined as the time from the diagnosis until death for any cause or the last follow-up.
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Up to 36 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Alessio G Morganti, Prof, Division of Radiation Oncology, S.Orsola-Malpighi Hospital, Bologna, Italy
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
2005년 1월 1일
기본 완료 (실제)
2008년 1월 1일
연구 완료 (실제)
2012년 2월 1일
연구 등록 날짜
최초 제출
2016년 3월 19일
QC 기준을 충족하는 최초 제출
2016년 3월 29일
처음 게시됨 (추정)
2016년 3월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 3월 30일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 3월 29일
마지막으로 확인됨
2016년 3월 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. .
Radiotherapy에 대한 임상 시험
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Joris B.W. ElbersErasmus Medical Center; HollandPTC모병두경부 편평 세포 암종 | 방사선 요법 | 양성자 치료 | 저분할 | 면역 체계 억제네덜란드
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Institut Investigacio Sanitaria Pere VirgiliInstitut Català d'Oncologia; Hospital Universitario Ramon y Cajal; Hospital Arnau de Vilanova 그리고 다른 협력자들모병
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Royal Marsden NHS Foundation TrustMerck Sharp & Dohme LLC종료됨