Study Stopped
Final analysis done, follow-up of patients no more necessary
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.
1 other identifier
interventional
88
1 country
78
Brief Summary
Relapses after perioperative chemotherapy and surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2007
Longer than P75 for phase_3
78 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 25, 2007
CompletedFirst Posted
Study publicly available on registry
September 26, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedFebruary 16, 2015
February 1, 2015
7.2 years
September 25, 2007
February 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
progression-free survival (PFS)
one year
Study Arms (2)
A
EXPERIMENTALB
ACTIVE COMPARATORDocetaxel monotherapy
Interventions
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)
Docetaxel 75 mg/m² D1 (D1=D22, 4 cycles) Docetaxel 75 mg/m² D1 (D1=D22, 2 cycles if disease control)
Eligibility Criteria
You may qualify if:
- 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)
- 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
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (78)
Centre Hospitalier
Aix-en-Provence, France
Annemasse - CH
Ambilly, 74100, France
Annecy - CH
Annecy, 74374, France
Auxerre - Polyclinique
Auxerre, 89000, France
Auxerre - CH
Auxerre, 89011, France
CH de la Côte Basque
Bayonne, France
Beauvais - CH
Beauvais, 60021, France
CHU Besancon - Pneumologie
Besançon, 25000, France
Blois - CH
Blois, 41016, France
APHP - CHU Avicenne - Oncologie Medicale
Bobigny, 93000, France
Boulogne - Ambroise Paré
Boulogne, France
Caen - Centre François Baclesse
Caen, 14000, France
CHU - Pneumologie
Caen, 14000, France
Calais - CH
Calais, 62017, France
CH de Cannes
Cannes, France
Chambray Les Tours - Clinique Léonard de Vinci
Chambray-lès-Tours, 37170, France
Chauny - CH
Chauny, France
Chevilly-Larue - CH
Chevilly-Larue, 94669, France
Hôpital de Cholet - Pneumologie
Cholet, France
Hôpital Percy-Armées - Pneumologie
Clamart, 92140, France
Hôpitral Gabriel Montpied - Pneumologie
Clermont-Ferrand, France
CH
Colmar, France
CHI Créteil
Créteil, France
Dax - CH
Dax, 40107, France
Dijon - CHU
Dijon, 21079, France
Epinal - CH
Épinal, 88021, France
CHU
Grenoble, France
Saint Omer - CHI
Helfaut, 62570, France
La Roche Sur Yon - CH
La Roche-sur-Yon, 85925, France
Chartres - CH
Le Coudray, 28630, France
Le Mans - Centre Hospitalier
Le Mans, 72000, France
Limoges - Hôpital du Cluzeau
Limoges, 87042, France
CH de Longjumeau
Longjumeau, France
HCL - Croix-Rousse
Lyon, 69000, France
Lyon - Clinique Mutualiste
Lyon, 69003, France
Hôpital Louis Pradel
Lyon, France
Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques
Marseille, France
Maubeuge - Polyclinique du Parc
Maubeuge, 59600, France
CH de Macon
Mâcon, France
Meaux - CH
Meaux, 77100, France
Mont de Marsan - CH
Mont-de-Marsan, 40000, France
Centre Hospitalier
Montélimar, France
Moulins - CH
Moulins, 03000, France
Mulhouse - CH
Mulhouse, 68000, France
CHU
Nancy, France
Nanterre - CH
Nanterre, 92014, France
Nantes - Centre René Gauducheau
Nantes, 44805, France
CH Nevers
Nevers, France
Nîmes - Clinique Valdegour
Nîmes, 30900, France
Orléans - CH
Orléans, 45000, France
APHP - Hopital Tenon - Pneumologie
Paris, 75020, France
GH Paris Saint-Joseph
Paris, France
Hôpital Saint Antoine
Paris, France
Centre Catalan d'Onologie
Perpignan, 66000, France
Perpignan - Ch
Perpignan, 66046, France
HCL - Lyon Sud (Pneumologie)
Pierre-Bénite, 69495, France
Centre Hospitalier
Rambouillet, France
Reims - CHU
Reims, 51092, France
Institut Jean Godinot
Reims, France
Rodez - CH
Rodez, 12021, France
Roncq - Clinique Saint-Roch
Roncq, 59223, France
Roubaix - CH
Roubaix, 59100, France
CH de Saint-Brieuc
Saint-Brieuc, France
Saint Nazaire - Centre Etienne Dolet
Saint-Nazaire, 44600, France
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, 42271, France
Saint Quentin - CH
Saint-Quentin, 02100, France
Saint-Malo - CH
St-Malo, 35403, France
CHU Lyautey - Pneumologie
Strasbourg, 63000, France
Hôpital Foch
Suresnes, France
Hôpitaux du Léman - Pneumologie et Maladies Infectieuruses
Thonon-les-Bains, France
Toulon - CHI
Toulon, 83000, France
Toulouse - CHU Larrey
Toulouse, France
Tours - CHU
Tours, 37000, France
Troyes - CH
Troyes, 10000, France
Valenciennes - Clinique
Valenciennes, 59304, France
CHI de la Haute-Saône - Pneumologie
Vesoul, France
Vienne - CH
Vienne, 38200, France
Institut Gustave Roussy
Villejuif, 94800, France
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Denis Moro-Sibilot, Pr
University Hospital, Grenoble
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2007
First Posted
September 26, 2007
Study Start
September 1, 2007
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
February 16, 2015
Record last verified: 2015-02