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NSCLC Relapse Therapy After Surgery and Peri-operative Chemotherapy

12. februar 2015 opdateret af: 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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

88

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: EN
Medicin: 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)
Aktiv komparator: B
Docetaxel monotherapy
Medicin: Chemotherapy without Cisplatine
Docetaxel 75 mg/m² D1 (D1=D22, 4 cycles) Docetaxel 75 mg/m² D1 (D1=D22, 2 cycles if disease control)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
progressionsfri overlevelse (PFS)
Tidsramme: et år
et år

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Intergroupe Francophone de Cancerologie Thoracique

Efterforskere

  • Ledende efterforsker: Denis Moro-Sibilot, Pr, University Hospital, Grenoble

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2007

Primær færdiggørelse (Faktiske)

1. november 2014

Studieafslutning (Faktiske)

1. november 2014

Datoer for studieregistrering

Først indsendt

25. september 2007

Først indsendt, der opfyldte QC-kriterier

25. september 2007

Først opslået (Skøn)

26. september 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. februar 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. februar 2015

Sidst verificeret

1. februar 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IFCT-0702

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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