- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00535275
NSCLC Relapse Therapy After Surgery and Peri-operative Chemotherapy
Comparison of 2 Chemotherapy Regimens in Non-small-cell Lung Cancer (NSCLC) Patients Relapsing After Surgery and Peri-operative Chemotherapy. A Randomized Phase III Study.
연구 개요
상세 설명
As chemotherapy gains wider acceptance for the treatment of earlier stages of NSCLC, particularly in the adjuvant and neoadjuvant setting, physicians face a growing population of high performance status patients who have relapsed after their first-line chemotherapy. The type of second-line chemotherapy after initial adjuvant or neoadjuvant treatment with a platinum-based regimen remains largely undefined. Some might consider rechallenging patients with a platinum based doublet whereas others might treat these patients with a monochemotherapy (pemetrexed or docetaxel).
Most relapses occurring after perioperative chemotherapy and surgery are non surgical locally advanced relapses or metastatic diseases.
Some differences exist between these post surgical relapses and the progressions occurring after the first line non surgical treatment of a stage III/IV.
- Patients are most often in a good condition (performance status 0-1).
- Progression is often asymptomatic and diagnosed in the post surgical follow up.
- The dose of chemotherapy previously administered is lower than that administered in first line of a stage III/IV.
- The time between the first line of treatment and the treatment of the relapse is longer.
These differences might be associated with a more chemosensitive disease and thus might be the rationale of using a platinum containing doublet instead of the classical mono chemotherapy docetaxel or pemetrexed.
Thus, the current study has been designed to answer these questions.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Aix En Provence, 프랑스
- Centre Hospitalier
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Ambilly, 프랑스, 74100
- Annemasse - CH
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Annecy, 프랑스, 74374
- Annecy - CH
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Auxerre, 프랑스, 89011
- Auxerre - CH
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Auxerre, 프랑스, 89000
- Auxerre - Polyclinique
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Bayonne, 프랑스
- CH de la Côte Basque
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Beauvais, 프랑스, 60021
- Beauvais - CH
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Besancon, 프랑스, 25000
- CHU Besancon - Pneumologie
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Blois, 프랑스, 41016
- Blois - CH
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Bobigny, 프랑스, 93000
- APHP - CHU Avicenne - Oncologie Medicale
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Boulogne, 프랑스
- Boulogne - Ambroise Paré
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Caen, 프랑스, 14000
- Caen - Centre François Baclesse
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Caen, 프랑스, 14000
- CHU - Pneumologie
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Calais, 프랑스, 62017
- Calais - CH
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Cannes, 프랑스
- CH de Cannes
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Chambray Les Tours, 프랑스, 37170
- Chambray Les Tours - Clinique Léonard de Vinci
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Chauny, 프랑스
- Chauny - CH
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Chevilly-Larue, 프랑스, 94669
- Chevilly-Larue - CH
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Cholet, 프랑스
- Hôpital de Cholet - Pneumologie
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Clamart, 프랑스, 92140
- Hôpital Percy-Armées - Pneumologie
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Clermont-Ferrand, 프랑스
- Hôpitral Gabriel Montpied - Pneumologie
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Colmar, 프랑스
- CH
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Créteil, 프랑스
- CHI Créteil
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Dax, 프랑스, 40107
- Dax - CH
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Dijon, 프랑스, 21079
- Dijon - CHU
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Epinal, 프랑스, 88021
- Epinal - CH
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Grenoble, 프랑스
- CHU
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Helfaut, 프랑스, 62570
- Saint Omer - CHI
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La Roche Sur Yon, 프랑스, 85925
- La Roche Sur Yon - CH
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Le Coudray, 프랑스, 28630
- Chartres - CH
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Le Mans, 프랑스, 72000
- Le Mans - Centre Hospitalier
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Limoges, 프랑스, 87042
- Limoges - Hôpital du Cluzeau
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Longjumeau, 프랑스
- CH de Longjumeau
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Lyon, 프랑스
- Hôpital Louis Pradel
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Lyon, 프랑스, 69003
- Lyon - Clinique Mutualiste
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Lyon, 프랑스, 69000
- HCL - Croix-Rousse
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Macon, 프랑스
- CH de Macon
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Marseille, 프랑스
- Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques
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Maubeuge, 프랑스, 59600
- Maubeuge - Polyclinique du Parc
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Meaux, 프랑스, 77100
- Meaux - CH
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Mont de Marsan, 프랑스, 40000
- Mont de Marsan - CH
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Montélimar, 프랑스
- Centre Hospitalier
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Moulins, 프랑스, 03000
- Moulins - CH
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Mulhouse, 프랑스, 68000
- Mulhouse - CH
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Nancy, 프랑스
- CHU
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Nanterre, 프랑스, 92014
- Nanterre - CH
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Nantes, 프랑스, 44805
- Nantes - Centre René Gauducheau
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Nevers, 프랑스
- CH Nevers
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Nîmes, 프랑스, 30900
- Nîmes - Clinique Valdegour
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Orléans, 프랑스, 45000
- Orléans - CH
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Paris, 프랑스
- Hopital Saint Antoine
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Paris, 프랑스, 75020
- APHP - Hopital Tenon - Pneumologie
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Paris, 프랑스
- GH Paris Saint-Joseph
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Perpignan, 프랑스, 66046
- Perpignan - Ch
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Perpignan, 프랑스, 66000
- Centre Catalan d'Onologie
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Pierre Bénite, 프랑스, 69495
- HCL - Lyon Sud (Pneumologie)
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Rambouillet, 프랑스
- Centre Hospitalier
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Reims, 프랑스, 51092
- Reims - CHU
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Reims, 프랑스
- Institut Jean Godinot
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Rodez, 프랑스, 12021
- Rodez - CH
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Roncq, 프랑스, 59223
- Roncq - Clinique Saint-Roch
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Roubaix, 프랑스, 59100
- Roubaix - CH
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Saint Nazaire, 프랑스, 44600
- Saint Nazaire - Centre Etienne Dolet
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Saint Quentin, 프랑스, 02100
- Saint Quentin - CH
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Saint-Brieuc, 프랑스
- CH de Saint-Brieuc
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Saint-Malo, 프랑스, 35403
- Saint-Malo - CH
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Saint-priest En Jarez, 프랑스, 42271
- Institut de Cancerologie de La Loire
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Strasbourg, 프랑스, 63000
- CHU Lyautey - Pneumologie
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Suresnes, 프랑스
- Hôpital FOCH
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Thonon, 프랑스
- Hôpitaux du Léman - Pneumologie et Maladies Infectieuruses
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Toulon, 프랑스, 83000
- Toulon - CHI
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Toulouse, 프랑스
- Toulouse - CHU Larrey
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Tours, 프랑스, 37000
- Tours - CHU
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Troyes, 프랑스, 10000
- Troyes - CH
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Valenciennes, 프랑스, 59304
- Valenciennes - Clinique
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Vesoul, 프랑스
- CHI de la Haute-Saône - Pneumologie
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Vienne, 프랑스, 38200
- Vienne - CH
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Villejuif, 프랑스, 94800
- Institut Gustave Roussy
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients with histologically or cytologically confirmed inoperable non-small cell-lung cancer not eligible for curative radio-therapy (local or metastatic relapse).
- Previous history of adjuvant or neoadjuvant chemotherapy (at least 2 full cycles of a platinum containing regimen)
- Initial stage pT1N0 to pT3N2 (TNM classification 1999), complete resection. T4 tumours (several nodules in the same lobe) and M1 tumours (several nodules in the same lung) N0-2 completely resected are allowed to inclusion. Histological complete response tumours (pT0N0) after neoadjuvant chemotherapy are allowed to inclusion.
- At least one unidimensionally measurable disease (RECIST criteria) (lesions must have clearly defined margins on X-ray, CT-scan, MRI or ultra-sound (US) examination and should measure at least 1 cm if assessed by CT, MRI or US and at least 2 cm if assessed by X-ray, target lesions should be selected outside a previously irradiated field ). PET scans and ultra sonography are not allowed
- ECOG Performance status 0 to 1).
- Patients with adequate biological functions:
- Written informed consent from patient.
- The effects of docetaxel, cisplatin and carboplatin on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because docetaxel, cisplatin and carboplatin as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Life expectancy > 12 weeks
- Patient compliance and geographic proximity that allow adequate follow-up.
- Patient affiliated to a social insurance program
Exclusion Criteria:
- Previous treatment with docetaxel.
- Hypersensitivity to docetaxel, cisplatin, carboplatin or polysorbate 80 (excipient).
- Previous history of cancer other than Non small cell lung cancer, in situ carcinoma of the uterine cervix and basal cell carcinoma of the skin.
- Patients previously treated by an investigational agent in the last 30 days.
- Patient treated with preoperative platin based chemotherapy, achieving a progression of disease after treatment evaluation.
- Patients non responders to preoperative chemotherapy and whose tumor specimen did not disclose any necrosis nor tumoral modification thus confirming the lack of chemosensitivity to platin based chemotherapy
- Patient treated with platin based adjuvant chemotherapy, relapsing within the first 6 months after surgery.
- Patients with a peripheral neuropathy grade CTC >= 2
- Patients unable to fulfill protocol requirements
- Serious concomitant morbidity incompatible with the study (at the discretion of the investigator).
- Relapse within the month following lung cancer resection or adjuvant chemotherapy
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Significant loss of weight (> 10 %) in the 6 weeks preceding patient selection.
- Concomitant administration of another anti cancer treatment
- Pregnant women are excluded from this study. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued.
- Patient under legal protection.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: ㅏ
|
Docetaxel 75 mg/m² D1 + Cisplatine 75 mg/m² or Carboplatin AUC5 D1 (D1=D22, 4 cycles) Docetaxel 75 mg/m² D1 (D1=D22, 2 cycles if disease control)
|
활성 비교기: B
Docetaxel monotherapy
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Docetaxel 75 mg/m² D1 (D1=D22, 4 cycles) Docetaxel 75 mg/m² D1 (D1=D22, 2 cycles if disease control)
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
무진행생존기간(PFS)
기간: 1년
|
1년
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Denis Moro-Sibilot, Pr, University Hospital, Grenoble
간행물 및 유용한 링크
유용한 링크
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. .
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