- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00271323
Safety Study of Docetaxel/Cisplatin Induction Therapy Followed by Concurrent Chemoradiotherapy or Concurrent Chemoradiotherapy Followed by Consolidation Docetaxel/Cisplatin in NSCLC Patients
A Two Arm Phase II Study Assessing Docetaxel/Cisplatin Induction Therapy Followed by Concurrent Chemoradiotherapy or Concurrent Chemoradiotherapy Followed by Consolidation Docetaxel/Cisplatin in Patients With Locally Advanced Unresectable NSCLC (Stage IIIA-multiple cN2 or IIIB)
- Primary : To determine the safety profile of each treatment group.
- Secondary : To determine efficacy in term of overall response, disease free survival and survival at 1 and 2 years.
연구 개요
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
-
-
-
Paris, 프랑스
- Sanofi-Aventis
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Informed consent form obtained, signed and dated before specific protocol procedures.
- Histologically or cytologically confirmed NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma or a combination of these)
Patients must have a loco regionally advanced unresectable NSCLC;
Stage IIIA with clinical multiple N2 nodes (preferably with histological or cytological confirmation).
- Patients with peripheral tumours of the lower lobe with contralateral upper mediastinal nodes at station N2 are excluded·
Stage IIIB T4 or N3.
- In the T4 category, patients with pleural or pericardial effusion and multiple nodules in the same lobe are excluded.
- Patients with T4 disease secondary to extensive and massive involvement of the great vessels are excluded.Patients should be excluded when the expected risk of pulmonary toxicity is likely to be high, e.g. V20 in excess of 35%.
- Males or females aged between 18 and 75 years.
- Life expectancy of at least 12 weeks.
- WHO performance status 0 or 1.
- Weight loss <=10% within the last 3 months.
Laboratory requirements at entry (within 7 days before randomization):
Blood cell counts:
- Absolute neutrophils >= 2.0 x 10^9/L
- Platelets >= 100 x 10^9/L
- Hemoglobin >= 10 g/dl
Renal function:
- Serum creatinine <=1 x the upper limit of normal (UNL). In case of borderline value of serum creatinine, the 24h creatinine clearance should be >= 60 mL/min.
Hepatic function:
- Serum bilirubin <= 1 x UNL
- ASAT and ALAT <= 2.5 x UNL
- Alkaline phosphatase <= 5 x UNL Patients with ASAT and/or ALAT > 1.5 x UNL associated with alkaline phosphatase> 2.5 x UNL are not eligible for the study.
Lung function tests at entry:
- FEV1: >= 50 % x Normal value
- DLCO: >= 50 % x Normal value
- Adequate cardiac function.
- Patient with either measurable and/or non-measurable lesion (according to RECIST criteria).
Exclusion Criteria:
- Diagnosis of small cell lung cancer.
- Pregnant or lactating women.
- Patients (male or female) with reproductive potential not implementing adequate contraceptive measures.
- Prior systemic chemotherapy, immunotherapy, or biological therapy including neoadjuvant or adjuvant treatment for NSCLC.
- Prior surgery for NSCLC, if less than 5 years from study.
- Prior radiotherapy for NSCLC.
- History of prior malignancies, except for cured non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least five years.
- Symptomatic peripheral neuropathy Grade >= 2 except if due to trauma.
Other serious concomitant illness or medical conditions:
- Congestive heart failure or angina pectoris except if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or arrhythmias.
- History of significant neurological or psychiatric disorders including dementia or seizures.
- Active infection requiring IV antibiotics.
- Active ulcer, unstable diabetes mellitus or other contra-indication to corticosteroid therapy.
- Superior vena cava syndrome contra-indicating hydration.
- Preexisting pericardial effusion.
- Preexisting symptomatic pleural effusion.
- Significant gastrointestinal abnormalities, including requirement for intravenous nutrition, active peptic ulcer disease, prior surgical procedures affecting absorption.
- Distant metastasis.
- Concurrent treatment with any other experimental anti-cancer drugs.
- Concomitant or within 4-week period administration of any other experimental drug under investigation.
- Significant ophthalmologic abnormalities.
- Moderate to severe dermatitis.
- Hypersensitivity to docetaxel, cisplatin, or any of its excipients.
- Concomitant use of phenytoin, carbamazepin, barbiturates, or rifampicin.
- Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
- Patient unlikely to comply with protocol, i.e., uncooperative attitude, inability to return for follow-up visits, and not likely to complete the study.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 |
---|---|
실험적: 1
Induction chemotherapy followed by concurrent chemoradiotherapy
|
Docetaxel (75 mg/m2, IV, Day 1) and cisplatin (40 mg/m2, IV, Day 1, 2) every 3 weeks for 2 cycles, followed by concurrent chemo-radiotherapy with docetaxel (20 mg/m2, IV) and cisplatin (20 mg/m2) weekly for 6 weeks + radiotherapy 2 Gy/day, 5 days per week to a total dose of 66 Gy.
|
활성 비교기: 2
Concurrent chemo-radiotherapy followed by consolidation chemotherapy
|
Docetaxel (20 mg/m2, IV) and cisplatin (20 mg/m2) weekly for 6 weeks + radiotherapy 2 Gy/day, 5 days per week to a total dose of 66 Gy followed by docetaxel (75 mg/m2, IV, Day 1) and cisplatin (40 mg/m2, IV, Day 1, 2) every 3 weeks for 2 cycles.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
overall response rate
기간: in population of patients eligible and evaluable for response
|
in population of patients eligible and evaluable for response
|
time to progression
기간: from the date of start treatment until progression
|
from the date of start treatment until progression
|
duration of response
기간: only on responders
|
only on responders
|
공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: M COUDERC, Dr, Sanofi
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
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 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. .
비소세포폐암에 대한 임상 시험
-
Millennium Pharmaceuticals, Inc.완전한GCB(Non-Germinal B-cell-like) 미만성 거대 B-세포 림프종(DLBCL)미국
docetaxel and cisplatin에 대한 임상 시험
-
University of OregonSpecial X Inc.모병부모-자녀 관계 | 육아 | 아동 행동 | 발달 장애 | 개발 지연 | 발달 장애, 아동미국
-
University Hospitals Cleveland Medical Center알려지지 않은
-
San Diego State UniversityRady Children's Hospital, San Diego알려지지 않은
-
Istituto per la Ricerca e l'Innovazione BiomedicaFondazione di Comunità di Messina onlus모병
-
GenSight Biologics모병
-
University of North Carolina, Chapel HillNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Splendor-NC모병비만 | 초과 중량 | 체중 | 체중 감량 | 체중 변화 | 만성 질환 | 과체중 및 비만 | 신체 활동 부족 | 행동, 식사 | 중량 감소미국
-
Dalarna UniversityUppsala University; The Swedish Research Council모병백치 | 가벼운 인지 장애 | 치매, 혼합 | 알츠하이머형 치매 | 주관적 인지 장애 | 치매 노인성스웨덴
-
Children's National Research InstituteAppleTree Institute; The Maddux School초대로 등록
-
Northwestern UniversityUniversity of Michigan; The University of Texas Health Science Center at San Antonio; University... 그리고 다른 협력자들완전한
-
Polares Medical SAPolares Medical, Inc.아직 모집하지 않음