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Study of Stereotactic Body Radiation Therapy for Patients After Radical Resection of Pancreatic Cancer With Advanced Stages (T3 or N1)

2017년 4월 4일 업데이트: Liang Tingbo, Second Affiliated Hospital, School of Medicine, Zhejiang University

An Open-Labeled, Randomized Phase II Trial of Adjuvant Chemotherapy in Combination With Stereotactic Body Radiation Therapy (SBRT) Versus Adjuvant Chemotherapy Alone for Patients After Radical Resection of Pancreatic Cancer With Advanced Stages (T3 or N1)

Pancreatic cancer is one of the deadliest tumor types of the alimentary system. Resection is the only curable method to treat pancreatic cancer. However, even if radical resection is achieved, the 5-year survival rate is still low because of tumor recurrence. It's reported adjuvant radiation can prolong survival and improve quality of life after surgery. For R0 (microscopic negative margin) resection patients with advanced stages (T3 or N1), the value of adjuvant radiation is still in debate. It's warranted to explore the role of adjuvant radiation for patients after radical resection of pancreatic cancer with advanced stages (T3 or N1) in large, prospective, and randomized cohorts.

The application of Stereotactic Body Radiation Therapy (SBRT) makes radiation less harmful and more flexible. It is hoped that adjuvant SBRT may benefit post-operative patients with advanced stages and one day adjuvant SBRT combined with chemotherapy become the standard of care for pancreatic cancer patients.

연구 개요

상태

알려지지 않은

정황

상세 설명

Pancreatic cancer is one of the deadliest tumor types of the alimentary system. Despite of the dramatic progress of diagnostic methods and surgical technics, the overall 5-year survival is still around 5%. Resection is the only curable method to treat pancreatic cancer, although only a small proportion of patients are eligible for operation. However, even if radical resection is achieved, the 5-year survival rate is only 15-20%. The main cause of death is tumor recurrence, which is as high as 50-70% in 3 years after operation. By now, it is widely accepted that pancreatic cancer is a systemic disease. Systemic treatments are recommended in neoadjuvant and adjuvant manners. It's reported adjuvant radiation can prolong survival and improve quality of life after surgery, especially for patients who undergo a R1 (microscopic positive margin) and R2 (macroscopic positive margin) resection. For R0 (microscopic negative margin) resection patients with advanced stages (T3 or N1), the value of adjuvant radiation is still in debate. Some argues adjuvant radiation after radical resection makes no effect on preventing local recurrence and metastasis but may impair patients' quality of life and overall survival. On the contrary, some other researchers draw the conclusion that adjuvant radiation may facilitate the local control of tumor recurrence in small cohorts. It's warranted to explore the role of adjuvant radiation for patients after radical resection of pancreatic cancer with advanced stages (T3 or N1) in large, prospective, and randomized cohorts.

Traditionally, radiation may take more than one month to deliver and the dosage is restricted to prevent damage to surrounding tissues. The size effects and duration impair patients' compliance. Recently, the application of Stereotactic Body Radiation Therapy (SBRT) makes radiation less harmful and more flexible. The advantages of SBRT are higher dosage of radiation, less damage to surrounding organs, and significant reduce of duration. To our knowledge, there is no big randomized clinical trial to evaluate the value of SBRT for patients after radical resection of pancreatic cancer with advanced stages (T3 or N1). It is hoped that adjuvant SBRT may benefit post-operative patients with advanced stages and one day adjuvant SBRT combined with chemotherapy become the standard of care for pancreatic cancer patients.

연구 유형

중재적

등록 (예상)

513

단계

  • 2 단계

연락처 및 위치

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

연구 장소

    • Zhejiang
      • Hangzhou, Zhejiang, 중국, 310009
        • 모병
        • The second affiliated hospital of Zhejiang University
        • 연락하다:

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:

  1. Male/Female subjects, age ≥ 18 years and ≤ 75 years old at the time informed consent is signed
  2. Pathologically confirmed pancreatic adenocarcinoma or mixed-type pancreatic carcinoma (adenocarcinoma predominantly)
  3. The operation must be radical resection (R0), with all margins negative.
  4. Eastern Cooperative Oncology Group (ECOG) score: 0-2
  5. Without large volume ascites or pleural effusion
  6. Lab tests:

    a Complete blood cell count: HGB≥100g/L, WBC≥4×109/L, PLT≥100×109/L b Liver function: Total bilirubin≤3 x upper limit of normal range (ULN) with direct bilirubin within normal range, alanine aminotransferase (ALT) / aspartate aminotransferase (AST)≤3 c Renal function: Creatine≤1.5 x ULN or creatine clearance≥60 ml/min

  7. Heart and lung function well (Eject function>55%)
  8. Females of child-bearing potential must demonstrate a negative serum pregnancy test result at screening confirmed by local negative urine pregnancy dipstick within 72 hours prior to the first dose of Gemcitabine.
  9. At least 30 days from major surgery before randomization, with full recovery
  10. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted
  11. Able to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria:

  1. Margin positive resections (R1 or R2)
  2. Resection of recurrence pancreatic cancer
  3. Other types of pancreatic cancer (non-adenocarcinoma)
  4. Subjects with severe complications, can't tolerate chemotherapy in 4-12 weeks after surgery
  5. Subjects with severe bone marrow suppression
  6. Subjects with a history of severe lung diseases (interstitial lung disease, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis), severe liver diseases (active hepatitis, liver cirrhosis), renal dysfunction, uncontrolled diabetes and hypertension, or multiple and severe allergies which may lead to serious complications
  7. Subjects with severe heart diseases (congested heart failure, systematic coronary disease, uncontrolled arrhythmia, or myocardial infarction in 6 months)
  8. Under treatment with steroids for a long time
  9. Subjects with early recurrence of pancreatic cancer before initiation of chemotherapy
  10. Subjects with diarrhea and infection (body temperature >38.5℃)
  11. Subjects who was enrolled into another clinical study or finished another clinical study within the previous 4 weeks prior to randomization
  12. Pregnant or nursing women
  13. Subjects with other type of malignancies, except of curated basal cell carcinoma and carcinoma in situ of cervix which finished treatments more than half one year ago
  14. Subjects having any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent them from participating in the study
  15. Any condition that confounds interpreting data from the study

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: Chemo
adjuvant chemotherapy using Gemcitabine for 6 rounds
Protocol: Gemcitabine 1000mg/m2.body surface area (BSA), IV infusion for at least 30 mins, administered at Day1, Day8, Day15)
다른 이름들:
  • 보석
실험적: Chemo+SBRT
SBRT is delivered prior to adjuvant chemotherapy with Gemcitabine for 6 rounds
Protocol: Gemcitabine 1000mg/m2.body surface area (BSA), IV infusion for at least 30 mins, administered at Day1, Day8, Day15)
다른 이름들:
  • 보석
Protocol: 5 Gy/d, for 5 consecutive days
다른 이름들:
  • Radio

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
disease-free survival (DFS)
기간: Up to approximately 36 months
Up to approximately 36 months

2차 결과 측정

결과 측정
측정값 설명
기간
overall survival (OS)
기간: Up to approximately 60 months
Up to approximately 60 months
quality of life (QOL) as assessed by the EORTC (European Organisation for Research and Treatment of Cancer) QLQ-PAN26 score
기간: Up to approximately 60 months
Up to approximately 60 months
safety as assessed according to NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) Ver. 4
기간: Up to approximately 8 months
according to NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) Ver. 4
Up to approximately 8 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Xueli Bai, MD PHD, Zhejiang University

간행물 및 유용한 링크

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

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

2015년 8월 1일

기본 완료 (예상)

2020년 6월 1일

연구 완료 (예상)

2020년 6월 1일

연구 등록 날짜

최초 제출

2015년 5월 28일

QC 기준을 충족하는 최초 제출

2015년 5월 31일

처음 게시됨 (추정)

2015년 6월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 4월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 4월 4일

마지막으로 확인됨

2017년 4월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

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. .

췌장암에 대한 임상 시험

Gemcitabine에 대한 임상 시험

3
구독하다