Evaluation of SBRT for Patients With Locally Advanced Unresectable Pancreatic Cancer
Phase II Trial Evaluating Stereotactic Body Radiation Therapy (SBRT) After Induction Chemotherapy for Patients With Locally Advanced Unresectable Pancreatic Cancer
연구 개요
상세 설명
The aim of this prospective mono-institutional phase II study is to assess the efficacy and safety of sequentially integrated treatment of FOLFIRINOX or Gemcitabine-Abraxane and SBRT with a total dose of 54 Gy in 6 fractions of 9 Gy /fractions in patients with locally unresectable pancreatic cancer.
Primary endpoint is to evaluate overall survival (OS); the overall survival time will be calculated from the start of chemotherapy to death. Secondary end points are to evaluate acute and late toxicities, freedom from local progression (FFLP) and progression free-survival (PFS). Acute and late toxicities will be scored according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Local progression will be defined according to RECIST criteria. Time to toxicity and time to local or distant progression will be defined from the start of chemotherapy.
Technical success will be defined as the ability to implant at least 2 fiducials in the tumor area. Migration will be defined as a change in inter-fiducial distance. Clinical success will be defined as the ability to guide the application of SBRT by using the fiducials. Any adverse event will be recorded (acute pancreatitis, clinically relevant upper GI bleeding requiring blood transfusion, abscesses in the area of the fiducials, sepsis).
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Milan
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Rozzano, Milan, 이탈리아, 20089
- HUMANITAS Research Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Histologically and/or radiologically (CT scan and/or MRI scan and/or FDG-PET) proven unresectable locally advanced pancreatic cancer, discussed multidisciplinary by tumor board.
- Eighteen years of age or older,
- Minimum Karnofsky Performance Status of 70.
- Lesions cannot exceed 5 cm in maximum diameter.
- Absence of lymph-nodal metastases
- Patients received 4-6 months of FOLFIRINOX or Gemcitabine-Abraxane before SBRT was administered.
- Baseline total body CT scan performed no more than 2 months before treatment.
- Placing fiducial markers through endoscopes is permitted (EUS-guided fiducials placement before the treatment).
- Acceptable organ and bone marrow function.
- Ability to maintain the set-up position during RT.
- All patients give informed consent and sign a study-specific informed consent form.
Exclusion Criteria:
- Metastatic disease
- Prior abdominal radiotherapy
- Other malignancies diagnosed within 5 years
- Gastric or duodenal obstruction.
- Concurrent chemotherapy.
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 |
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실험적: SBRT and chemotherapy
Participants received 4 months of FOLFIRINOX or Gemcitabine-Abraxane before SBRT was administered. A 3-weeks break from chemotherapy and restaging with thorax-abdominal CT scan to confirm the absence of distant metastases was required before SBRT delivery. Before SBRT simulation, patients may will have implanted fiducial into the pancreatic tumor. The SBRT schedule will be [6 x 9 Gy = 54 Gy] delivered in consecutive days. |
Patients affected by locally unresectable pancreatic cancer receive integrated treatment of FOLFIRINOX or Gemcitabine-Abraxane and a Stereotactic Body Radiation Therapy with a total dose of 54 Gy in 6 fractions of 9 Gy /fractions.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Overall survival
기간: 2 years
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Evaluation of SBRT after induction CT with FOLFIRINOX or Gemcitabine-Abraxane in terms of overall survival time that will be calculated from the start of chemotherapy to death.
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2 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Incidence of acute toxicities
기간: 2 years
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Evaluation of early post treatment complications according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
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2 years
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Incidence of late toxicities
기간: 4 years
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Evaluation of late post treatment complications according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
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4 years
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Freedom from local progression in treated patients
기간: 2 years
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Evaluation of proportion of patients free from local progression according to RECIST criteria
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2 years
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Progression free-survival of treated patients
기간: 2 years
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Evaluation of proportions of patients alive and free form progression according to RECIST criteria
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2 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Marta Scorsetti, MD, Istituto Clinico Humanitas
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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 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. .
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Radiation Therapy Oncology GroupNational Cancer Institute (NCI); NRG Oncology완전한
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Dalarna UniversityUppsala University; The Swedish Research Council모병백치 | 가벼운 인지 장애 | 치매, 혼합 | 알츠하이머형 치매 | 주관적 인지 장애 | 치매 노인성스웨덴
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