- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01303926
Quality of Life Comparison in Advanced Non-squamous Non Small Cell Lung Cancer (ERACLE)
Induction Pemetrexed and Cisplatin Followed by Pemetrexed as Maintenance vs Carboplatin-paclitaxel and Bevacizumab Followed by Bevacizumab as Maintenance:Multicenter Randomized Phase III Study in Patients With Advanced Non-Squamous Non Small-cell Lung Cancer: a Quality of Life Oriented Phase III Trial of the GOIM
연구 개요
상태
상세 설명
The study aims primarily to verify the null hypothesis that between the two schemes under consideration there is no minimal interesting difference (MID) (i.e. a difference of clinical interest) after initial 3 months of maintenance.EuroQ5D (EQ5D) questionnaire total score and EQ5D visual analog scale (VAS)are validated and very simple to be administered.The statistical hypothesis tests described above are performed with t-test for unpaired data (or equivalent non-parametric, pending verification of normality of distribution by Shapiro-Wilk test), with alpha error = 0.05 (2-sided). It is assumed that:
- about 20% of randomized patients experienced a progression of disease before the time of evaluation of the primary endpoint, and that
- this eventuality was not significantly different between the two treatments. The total sample to be enrolled for this study will then be increased to 118 patients [(49 +49) +20%)]
연구 유형
등록 (예상)
단계
- 3단계
연락처 및 위치
연구 장소
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Napoli, 이탈리아
- National Cancer Institute "G. Pascale" Thoracic Dept.
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BA
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Bari, BA, 이탈리아, 70124
- "Giovanni Paolo II" Oncology Institute
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Bari, BA, 이탈리아
- "San Paolo Hospital" Oncology Service
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BN
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Benevento, BN, 이탈리아
- Division of Medical Oncology, "Fatebenefratelli" Hospital
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BR
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Brindisi, BR, 이탈리아, 72100
- Division of Medical Oncology, "Sen. Perrino" Hospital, Brindisi, Italy
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FG
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San Giovanni Rotondo, FG, 이탈리아
- 7 Division of Medical Oncology, "Casa Sollievo della Sofferenza" Hospital,
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Le
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Lecce, Le, 이탈리아
- Medical Oncology Division "Vito Fazzi" Hospital
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PA
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Palermo, PA, 이탈리아
- Division of Medical Oncology, "Buccheri-La Ferla" Hospital
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Palermo, PA, 이탈리아
- Division of Medical Oncology, "La Maddalena" Hospital
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TA
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Castellaneta, TA, 이탈리아
- Division of Medical Oncology, Castellaneta Hospital
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Taranto, TA, 이탈리아
- Division of Medical Oncology "San Giuseppe Moscati Hospital"
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VE
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Mirano, VE, 이탈리아
- Clinical Trials Office, Department of Medical Sciences, Azienda ULSS 13
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Written informed consent(as approved by the local Ethical Committee)
- Histological type consisting mainly of non-squamous histology defined preferably with stage IV metastatic disease or stage IIIB in the presence of supraclavicular lymph nodes according to the parameters of TNM 7th Ed, not amenable to curative therapy
- ECOG PS 0-1
- Adequate bone marrow reserve
- Adequate hepatic, coagulative and renal function
Exclusion Criteria:
- Mixed NSCLC tumors or mixed adenosquamous carcinomas with a predominant squamous component histotype (NSCLC and SCLC) or adenosquamous forms, with predominant squamous component
- History of gross hemoptysis <3 months prior to enrollment or history or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding.
- Tumors invading or abutting major blood vessels (based on radiologist assessment)
- Evidence of brain metastases not previously treated with RT (or any loco-regional treatment)
- Prior neoadjuvant or adjuvant chemotherapy within six months prior to study enrollment
- Previous radiotherapy in the last month before study entry (except for radiotherapy to symptomatic bone sites at risk and not covered in the premises of measurable disease and assessable)
- A major surgery (including open biopsy) in the month preceding study enrollment or anticipation of a major surgery during the study
- Unable or unwilling to take folic acid or vitamin B12 supplementation
- Unable or unwilling to take corticosteroids
- History of gastrointestinal fistula, perforation, or abscess, inflammatory bowel disease, or diverticulitis
- Clinically significant third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry
- Need for taking or have recently taken (within 10 days of enrollment) aspirin (>325 mg/d), clopidogrel at doses >75 mg/d, dipyramidole, ticlopidine, or cilostazol. Patients are also excluded if they cannot hold nonsteroidal anti-inflammatory agents, other than prophylactic therapy with low-dose aspirin, for a 5-day period during each cycle (8-day period for long-acting agents, such as piroxicam)
- Need for taking or have recently taken (within 10 days of enrollment) fulldose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes. Prophylactic use of anticoagulants is allowed; international normalized ratio (INR) should be <1.5 at study enrollment
- History of thrombotic disorders within the last 6 months prior to entry History of hypertension, unless hypertension is well controlled study entry (≤150/90 mm Hg) and the patient is on a stable regimen of antihypertensive therapy. Patients should not have any prior history of hypertensive crisis or hypertensive encephalopathy
- Serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV
- Serious concomitant systemic disorder (for example, active infection including human immunodeficiency virus) that, in the opinion of the investigator, would compromise the patient's ability to adhere to the protocol
- Receiving concurrent administration of any other antitumor therapy
- Have a second primary malignancy that is clinically detectable at the time of consideration for study enrollment
- Have had a prior malignancy other than NSCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence. Patients with a history of low grade (Gleason score ≤6) localized prostate cancer will be eligible even if diagnosed less than 5 years previously
- Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
공부 계획
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 |
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활성 비교기: Cisplatin and Pemetrexed
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Cisplatin 75 mg / m2 d1 with Pemetrexed 500 mg / m2 d1 every 3 weeks for 6 cycles followed (in responding or stable patients) by Pemetrexed 500 mg / m2 every 3 weeks, until progression or unacceptable toxicity
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활성 비교기: Carboplatin paclitaxel bevacizumab
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Carboplatin AUC 6 d1 plus Paclitaxel 200 mg/m2 d1 and Bevacizumab 15 mg/kg every 3 weeks for 6 cycles followed in stable or responding patients by Bevacizumab 15 mg/kg every 3 weeks, until progression or unacceptable toxicity
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Difference in terms of quality of life (QOL) between treatment arms
기간: Treatment efficacy will be evaluated at baseline and every 3 cycles during chemo period and every two months during the maintenance phase
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Treatment efficacy will be evaluated at baseline and every 3 cycles during chemo period and every two months during the maintenance phase
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2차 결과 측정
결과 측정 |
기간 |
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treatment activity in terms of response rate
기간: Two year
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Two year
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toxicity evaluation
기간: Two years
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Two years
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Evaluation of QoL across time
기간: Two years
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Two years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Giuseppe Colucci, MD, Oncology Institute of Bari
- 연구 책임자: Domenico Galetta, MD, "Giovanni Paolo II" Oncology Instutute Medical Oncology Dept. Bari (Italy)
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Goim 2903
- 2009-015807-19 (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. .
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