NSCLC Relapse Therapy After Surgery and Peri-operative Chemotherapy

February 12, 2015 updated by: Intergroupe Francophone de Cancerologie Thoracique

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.

Relapses after perioperative chemotherapy and surgery

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aix En Provence, France
        • Centre hospitalier
      • Ambilly, France, 74100
        • Annemasse - CH
      • Annecy, France, 74374
        • Annecy - CH
      • Auxerre, France, 89011
        • Auxerre - CH
      • Auxerre, France, 89000
        • Auxerre - Polyclinique
      • Bayonne, France
        • CH de la Côte Basque
      • Beauvais, France, 60021
        • Beauvais - CH
      • Besancon, France, 25000
        • CHU Besancon - Pneumologie
      • Blois, France, 41016
        • Blois - CH
      • Bobigny, France, 93000
        • APHP - CHU Avicenne - Oncologie Medicale
      • Boulogne, France
        • Boulogne - Ambroise Paré
      • Caen, France, 14000
        • Caen - Centre François Baclesse
      • Caen, France, 14000
        • CHU - Pneumologie
      • Calais, France, 62017
        • Calais - CH
      • Cannes, France
        • CH de Cannes
      • Chambray Les Tours, France, 37170
        • Chambray Les Tours - Clinique Léonard de Vinci
      • Chauny, France
        • Chauny - CH
      • Chevilly-Larue, France, 94669
        • Chevilly-Larue - CH
      • Cholet, France
        • Hôpital de Cholet - Pneumologie
      • Clamart, France, 92140
        • Hôpital Percy-Armées - Pneumologie
      • Clermont-Ferrand, France
        • Hôpitral Gabriel Montpied - Pneumologie
      • Colmar, France
        • CH
      • Créteil, France
        • Chi Creteil
      • Dax, France, 40107
        • Dax - CH
      • Dijon, France, 21079
        • Dijon - CHU
      • Epinal, France, 88021
        • Epinal - CH
      • Grenoble, France
        • CHU
      • Helfaut, France, 62570
        • Saint Omer - CHI
      • La Roche Sur Yon, France, 85925
        • La Roche Sur Yon - CH
      • Le Coudray, France, 28630
        • Chartres - CH
      • Le Mans, France, 72000
        • Le Mans - Centre Hospitalier
      • Limoges, France, 87042
        • Limoges - Hôpital du Cluzeau
      • Longjumeau, France
        • CH de Longjumeau
      • Lyon, France
        • Hôpital Louis Pradel
      • Lyon, France, 69003
        • Lyon - Clinique Mutualiste
      • Lyon, France, 69000
        • HCL - Croix-Rousse
      • Macon, France
        • CH de Macon
      • Marseille, France
        • Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques
      • Maubeuge, France, 59600
        • Maubeuge - Polyclinique du Parc
      • Meaux, France, 77100
        • Meaux - CH
      • Mont de Marsan, France, 40000
        • Mont de Marsan - CH
      • Montélimar, France
        • Centre hospitalier
      • Moulins, France, 03000
        • Moulins - CH
      • Mulhouse, France, 68000
        • Mulhouse - CH
      • Nancy, France
        • CHU
      • Nanterre, France, 92014
        • Nanterre - CH
      • Nantes, France, 44805
        • Nantes - Centre René Gauducheau
      • Nevers, France
        • CH Nevers
      • Nîmes, France, 30900
        • Nîmes - Clinique Valdegour
      • Orléans, France, 45000
        • Orléans - CH
      • Paris, France
        • Hôpital Saint Antoine
      • Paris, France, 75020
        • APHP - Hopital Tenon - Pneumologie
      • Paris, France
        • GH Paris Saint-Joseph
      • Perpignan, France, 66046
        • Perpignan - Ch
      • Perpignan, France, 66000
        • Centre Catalan d'Onologie
      • Pierre Bénite, France, 69495
        • HCL - Lyon Sud (Pneumologie)
      • Rambouillet, France
        • Centre hospitalier
      • Reims, France, 51092
        • Reims - CHU
      • Reims, France
        • Institut Jean Godinot
      • Rodez, France, 12021
        • Rodez - CH
      • Roncq, France, 59223
        • Roncq - Clinique Saint-Roch
      • Roubaix, France, 59100
        • Roubaix - CH
      • Saint Nazaire, France, 44600
        • Saint Nazaire - Centre Etienne Dolet
      • Saint Quentin, France, 02100
        • Saint Quentin - CH
      • Saint-Brieuc, France
        • CH de Saint-Brieuc
      • Saint-Malo, France, 35403
        • Saint-Malo - CH
      • Saint-priest En Jarez, France, 42271
        • Institut de Cancerologie de La Loire
      • Strasbourg, France, 63000
        • CHU Lyautey - Pneumologie
      • Suresnes, France
        • Hopital Foch
      • Thonon, France
        • Hôpitaux du Léman - Pneumologie et Maladies Infectieuruses
      • Toulon, France, 83000
        • Toulon - CHI
      • Toulouse, France
        • Toulouse - CHU Larrey
      • Tours, France, 37000
        • Tours - CHU
      • Troyes, France, 10000
        • Troyes - CH
      • Valenciennes, France, 59304
        • Valenciennes - Clinique
      • Vesoul, France
        • CHI de la Haute-Saône - Pneumologie
      • Vienne, France, 38200
        • Vienne - CH
      • Villejuif, France, 94800
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
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)
Active Comparator: B
Docetaxel monotherapy
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression-free survival (PFS)
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intergroupe Francophone de Cancerologie Thoracique

Investigators

  • Principal Investigator: Denis Moro-Sibilot, Pr, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

September 25, 2007

First Submitted That Met QC Criteria

September 25, 2007

First Posted (Estimate)

September 26, 2007

Study Record Updates

Last Update Posted (Estimate)

February 16, 2015

Last Update Submitted That Met QC Criteria

February 12, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IFCT-0702

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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