NSCLC Relapse Therapy After Surgery and Peri-operative Chemotherapy

Carcinoma, Non-Small-Cell Lung Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00535275
• Other study ID #: IFCT-0702
• Status: Terminated
• Phase: Phase 3
• First received: September 25, 2007
• Last updated: February 12, 2015
• Start date: September 2007
• Est. completion date: November 2014

Study information

• Verified date: February 2015
• Source: Intergroupe Francophone de Cancerologie Thoracique
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

Relapses after perioperative chemotherapy and surgery

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 88
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Chemotherapy with platine
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)
• Chemotherapy without Cisplatine
Docetaxel 75 mg/m² D1 (D1=D22, 4 cycles) Docetaxel 75 mg/m² D1 (D1=D22, 2 cycles if disease control)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Intergroupe Francophone de Cancerologie Thoracique

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival (PFS)		one year	Yes

External Links

•   IFCT official website