Clinical trial NCT00535275: NSCLC Relapse Therapy After Surgery and Peri-operative Chemotherapy
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: NSCLC relapse after adjuvant chemotherapy
Lead sponsor: Intergroupe Francophone de Cancerologie Thoracique
Sponsor class: OTHER
First posted: 2007-09-26
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Relapses after perioperative chemotherapy and surgery

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: progression-free survival (PFS)
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Aix En Provence
country: France
facility: Centre Hospitalier
city: Ambilly
country: France
facility: Annemasse - CH
city: Annecy
country: France
facility: Annecy - CH
city: Auxerre
country: France
facility: Auxerre - Polyclinique
city: Auxerre
country: France
facility: Auxerre - CH
city: Bayonne
country: France
facility: CH de la Côte Basque
city: Beauvais
country: France
facility: Beauvais - CH
city: Besancon
country: France
facility: CHU Besancon - Pneumologie
city: Blois
country: France
facility: Blois - CH
city: Bobigny
country: France
facility: APHP - CHU Avicenne - Oncologie Medicale
city: Boulogne
country: France
facility: Boulogne - Ambroise Paré
city: Caen
country: France
facility: Caen - Centre François Baclesse
city: Caen
country: France
facility: CHU - Pneumologie
city: Calais
country: France
facility: Calais - CH
city: Cannes
country: France
facility: CH de Cannes
city: Chambray Les Tours
country: France
facility: Chambray Les Tours - Clinique Léonard de Vinci
city: Chauny
country: France
facility: Chauny - CH
city: Chevilly-Larue
country: France
facility: Chevilly-Larue - CH
city: Cholet
country: France
facility: Hôpital de Cholet - Pneumologie
city: Clamart
country: France
facility: Hôpital Percy-Armées - Pneumologie
city: Clermont-Ferrand
country: France
facility: Hôpitral Gabriel Montpied - Pneumologie
city: Colmar
country: France
facility: CH
city: Créteil
country: France
facility: CHI Créteil
city: Dax
country: France
facility: Dax - CH
city: Dijon
country: France
facility: Dijon - CHU
city: Epinal
country: France
facility: Epinal - CH
city: Grenoble
country: France
facility: CHU
city: Helfaut
country: France
facility: Saint Omer - CHI
city: La Roche Sur Yon
country: France
facility: La Roche Sur Yon - CH
city: Le Coudray
country: France
facility: Chartres - CH
city: Le Mans
country: France
facility: Le Mans - Centre Hospitalier
city: Limoges
country: France
facility: Limoges - Hôpital du Cluzeau
city: Longjumeau
country: France
facility: CH de Longjumeau
city: Lyon
country: France
facility: HCL - Croix-Rousse
city: Lyon
country: France
facility: Lyon - Clinique Mutualiste
city: Lyon
country: France
facility: Hôpital Louis Pradel
city: Macon
country: France
facility: CH de Macon
city: Marseille
country: France
facility: Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques
city: Maubeuge
country: France
facility: Maubeuge - Polyclinique du Parc
city: Meaux
country: France
facility: Meaux - CH
city: Mont de Marsan
country: France
facility: Mont de Marsan - CH
city: Montélimar
country: France
facility: Centre Hospitalier
city: Moulins
country: France
facility: Moulins - CH
city: Mulhouse
country: France
facility: Mulhouse - CH
city: Nancy
country: France
facility: CHU
city: Nanterre
country: France
facility: Nanterre - CH
city: Nantes
country: France
facility: Nantes - Centre René Gauducheau
city: Nevers
country: France
facility: CH Nevers
city: Nîmes
country: France
facility: Nîmes - Clinique Valdegour
city: Orléans
country: France
facility: Orléans - CH
city: Paris
country: France
facility: APHP - Hopital Tenon - Pneumologie
city: Paris
country: France
facility: GH Paris Saint-Joseph
city: Paris
country: France
facility: Hôpital Saint Antoine
city: Perpignan
country: France
facility: Centre Catalan d'Onologie
city: Perpignan
country: France
facility: Perpignan - Ch
city: Pierre Bénite
country: France
facility: HCL - Lyon Sud (Pneumologie)
city: Rambouillet
country: France
facility: Centre Hospitalier
city: Reims
country: France
facility: Reims - CHU
city: Reims
country: France
facility: Institut Jean Godinot
city: Rodez
country: France
facility: Rodez - CH
city: Roncq
country: France
facility: Roncq - Clinique Saint-Roch
city: Roubaix
country: France
facility: Roubaix - CH
city: Saint Nazaire
country: France
facility: Saint Nazaire - Centre Etienne Dolet
city: Saint Quentin
country: France
facility: Saint Quentin - CH
city: Saint-Brieuc
country: France
facility: CH de Saint-Brieuc
city: Saint-Malo
country: France
facility: Saint-Malo - CH
city: Saint-priest En Jarez
country: France
facility: Institut de Cancérologie de la Loire
city: Strasbourg
country: France
facility: CHU Lyautey - Pneumologie
city: Suresnes
country: France
facility: Hôpital Foch
city: Thonon
country: France
facility: Hôpitaux du Léman - Pneumologie et Maladies Infectieuruses
city: Toulon
country: France
facility: Toulon - CHI
city: Toulouse
country: France
facility: Toulouse - CHU Larrey
city: Tours
country: France
facility: Tours - CHU
city: Troyes
country: France
facility: Troyes - CH
city: Valenciennes
country: France
facility: Valenciennes - Clinique
city: Vesoul
country: France
facility: CHI de la Haute-Saône - Pneumologie
city: Vienne
country: France
facility: Vienne - CH
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: University Hospital, Grenoble
name: Denis Moro-Sibilot, Pr
role: PRINCIPAL_INVESTIGATOR
References: