NSCLC Relapse Therapy After Surgery and Peri-operative Chemotherapy

NCT ID: NCT00535275

Last Updated: 2015-02-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2014-11-30

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Group Type: EXPERIMENTAL

Chemotherapy with platine

Intervention Type: DRUG

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)

B

Docetaxel monotherapy

Group Type: ACTIVE_COMPARATOR

Chemotherapy without Cisplatine

Intervention Type: DRUG

Docetaxel 75 mg/m² D1 (D1=D22, 4 cycles) Docetaxel 75 mg/m² D1 (D1=D22, 2 cycles if disease control)

Interventions

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)

Intervention Type: DRUG

Chemotherapy without Cisplatine

Docetaxel 75 mg/m² D1 (D1=D22, 4 cycles) Docetaxel 75 mg/m² D1 (D1=D22, 2 cycles if disease control)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Intergroupe Francophone de Cancerologie Thoracique

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Denis Moro-Sibilot, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

Centre Hospitalier

Aix-en-Provence, , France

Annemasse - CH

Ambilly, , France

Annecy - CH

Annecy, , France

Auxerre - Polyclinique

Auxerre, , France

Auxerre - CH

Auxerre, , France

CH de la Côte Basque

Bayonne, , France

Beauvais - CH

Beauvais, , France

CHU Besancon - Pneumologie

Besançon, , 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-lès-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

Épinal, , 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

Lyon - Clinique Mutualiste

Lyon, , France

Hôpital Louis Pradel

Lyon, , France

Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques

Marseille, , France

Maubeuge - Polyclinique du Parc

Maubeuge, , France

CH de Macon

Mâcon, , 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

Reims - CHU

Reims, , France

Institut Jean Godinot

Reims, , France

Rodez - CH

Rodez, , France

Roncq - Clinique Saint-Roch

Roncq, , France

Roubaix - CH

Roubaix, , France

CH de Saint-Brieuc

Saint-Brieuc, , France

Saint Nazaire - Centre Etienne Dolet

Saint-Nazaire, , France

Institut de Cancérologie de la Loire

Saint-Priest-en-Jarez, , France

Saint Quentin - CH

Saint-Quentin, , France

Saint-Malo - CH

St-Malo, , France

CHU Lyautey - Pneumologie

Strasbourg, , France

Hôpital Foch

Suresnes, , France

Hôpitaux du Léman - Pneumologie et Maladies Infectieuruses

Thonon-les-Bains, , 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, , France

Countries

France

Related Links

http://www.ifct.fr

IFCT official website

Other Identifiers

IFCT-0702

Identifier Type: -

Identifier Source: org_study_id