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Radiation Therapy + Combination Chemotherapy as 1st-Line Therapy for Patients With Inoperable Esophageal Cancer

17 dicembre 2015 aggiornato da: UNICANCER

Phase II-III Study Comparing Radiochemotherapy With the FOLFOX Regimen Versus Radiochemotherapy With 5FU-cisplatin (Herskovic Regimen) in First Line Treatment of Patients With Inoperable Oesophageal Cancer.

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, leucovorin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.

PURPOSE: This randomized phase II/III trial is studying radiation therapy and two different combination chemotherapy regimens to compare how well they work as first-line therapy in treating patients with esophageal cancer that cannot be removed by surgery.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

OBJECTIVES:

Primary

  • To assess the feasibility of radiochemotherapy comprising oxaliplatin, fluorouracil, and leucovorin calcium (FOLFOX regimen) vs fluorouracil and cisplatin (Herskovic regimen) in patients with inoperable esophageal cancer. (Phase II)
  • To assess the endoscopic complete response rate in patients treated with these regimens. (Phase II)
  • To compare the event-free survival of patients treated with these regimens. (Phase III)

Secondary

  • To assess the toxicity profile of these regimens using the NCI CTC v2.0 criteria. (Phase II)
  • To compare the overall survival, endoscopic complete response rate, incidence of grade 3-4 toxicities, and time to treatment failure in patients treated with these regimens. (Phase III)
  • To evaluate the quality of life of these patients using EORTC QLQ-C30 (version 3) and a validated disease-specific module EORTC QLQ-OES18. (Phase III)

OUTLINE: This is a multicenter study. Patients are stratified according to histological type (adenocarcinoma or adenosquamous carcinoma vs squamous cell carcinoma), pretreatment weight loss within the past 6 months (grade 1 [< 10%] vs grade 2 [≥ 10%]), ECOG performance status (0 vs 1 vs 2), and participating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I (modified FOLFOX 4 regimen): Patients undergo radiotherapy 5 days a week for 5 weeks. Beginning concurrently with radiotherapy, patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment with chemotherapy repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II (Herskovic regimen): Patients undergo radiotherapy as in arm I. Patients also receive cisplatin IV continuously over 24 hours on day 1 and fluorouracil IV continuously over 96 hours on days 1-4 of weeks 1, 5, 8, and 11 in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, periodically during study therapy, and then every 6 months for 1 year and annually for 3 years after completion of study therapy.

After completion of study therapy, patients are followed at 4 weeks and then every 3-6 months until disease progression.

PROJECTED ACCRUAL: A total of 97 patients will be accrued for the phase II portion of the study. A total of 169 patients will be accrued for the phase III portion of the study.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

266

Fase

  • Fase 2
  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Francia
      • Besancon, Francia, 25030
        • CHR de Besancon - Hopital Saint-Jacques
      • Bordeaux, Francia, 33076
        • Institut Bergonie
      • Bordeaux, Francia, 33075
        • Hopital Saint André
      • Boulogne-Billancourt, Francia, F-92104
        • Hôpital Ambroise Paré
      • Caen, Francia, 14076
        • Centre Regional Francois Baclesse
      • Caen, Francia, 14052
        • Polyclinique du Parc
      • Dijon, Francia, 21034
        • Hôpital du Bocage
      • Dijon, Francia, 21079
        • Centre de Lutte Contre le Cancer Georges-Francois Leclerc
      • Lille, Francia, 59020
        • Centre Oscar Lambret
      • Limoges, Francia, 87042
        • Centre Hospital Regional Universitaire de Limoges
      • Lyon, Francia, 69373
        • Centre Léon Bérard
      • Marseille, Francia, 13385
        • CHU de la Timone
      • Montpellier, Francia, 34298
        • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
      • Nice, Francia, 06189
        • Centre Antoine Lacassagne
      • Paris, Francia, 75015
        • Hôpital Europeén Georges Pompidou
      • Paris, Francia, 75970
        • Hôpital Tenon
      • Paris, Francia, 75475
        • Hôpital Saint-Louis
      • Poitiers, Francia, 86021
        • CHU Poitiers
      • Reims, Francia, 51092
        • CHU - Robert Debre
      • Reims, Francia, 51056
        • Institut Jean Godinot
      • Rennes, Francia, 35042
        • Centre Eugene Marquis
      • Rouen, Francia, 76031
        • Hôpital Charles Nicolle
      • Saint Brieuc, Francia, F-22015
        • Clinique Armoricaine de Radiologie
      • Strasbourg, Francia, 67065
        • Centre Paul Strauss
      • Toulouse, Francia, 31052
        • Institut Claudius Regaud
      • Toulouse, Francia, 31078
        • Clinique du Parc
      • Vandoeuvre-les-Nancy, Francia, 54511
        • Centre Alexis Vautrin
      • Villejuif, Francia, F-94805
        • Institut Gustave Roussy

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

DISEASE CHARACTERISTICS:

  • Histologically proven adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma of the esophagus

    • Locally advanced disease (any T, N0 or N1, M0 or M1a)

      • No metastatic disease, except for tumor involvement of the upper third of the esophagus or cervical esophageal tumor with regional nodes, or tumor involvement of the lower third of the esophagus with celiac nodes (M1a)

        • Cervical primary tumor with positive supraclavicular or cervical lymph nodes (defined as N1) allowed
        • No radiographic evidence of enlarged (≥ 1.5 cm) celiac lymph nodes by CT scan or echography
    • No small cell or undifferentiated carcinoma of the esophagus
    • No multiple carcinomas of the esophagus (i.e., > 1 esophageal tumor)

    • No cardia tumor (Siewert II) or gastric tumor extension to the esophagus (Siewert III)

      • Esophageal tumor extension to the cardia (Siewert I) (center of the tumor lying > 1 cm-5 cm above gastroesophageal junction) allowed
  • Inoperable disease OR surgery is contraindicated
  • No tracheo-esophageal fistula or invasion of the tracheo-bronchial tree

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 3 months
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 10 g/dL (transfusion allowed)
  • Creatinine < 15 mg/L
  • Total bilirubin < 1.5 times upper limit of normal (ULN)
  • ALT and AST < 2.5 times ULN
  • Prothrombin time ≥ 60%
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Caloric intake sufficient (i.e., > 1,000 Kcal/m²/day) (orally or with gastrostomy)
  • No weight loss > 20% normal body weight within the past 3 months
  • No complete dysphagia
  • No exclusive requirement for parenteral nutrition

  • No peripheral neuropathy > grade 1

    • No sensitive peripheral neuropathy with functional impairment
  • No auditory disorders
  • No other prior malignancies except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix or stage I or II node-negative head and neck cancer that was curatively treated > 3 years ago

  • No myocardial infarction within the past 6 months

    • Patients who have had a myocardial infarction > 6 months ago are eligible provided there is no transient ischemia by thallium myocardial scintigraphy and patient is able to undergo chemotherapy , as determined by a cardiologist
  • No other serious illness or medical condition (e.g., symptomatic coronary disease, left ventricular failure, or uncontrolled infection)
  • No stage II-IV arterial disease, according to the DE LERICHE and FONTAINE classification
  • No geographical, social, or psychological circumstances preventing regular follow-up

PRIOR CONCURRENT THERAPY:

  • No prior treatment for esophageal cancer (e.g., surgery, chemotherapy, or radiotherapy)
  • No prior cervical, thoracic, or abdominal radiotherapy with field overlapping the proposed esophageal radiotherapy field
  • More than 30 days since prior experimental drugs or participation in another clinical trial
  • No other concurrent anticancer therapy
  • No concurrent phenytoin or yellow fever vaccine
  • No concurrent high-dose, long-term corticosteroids
  • No concurrent calcium gluconate/magnesium sulfate infusions
  • No concurrent hematopoietic growth factors
  • No concurrent esophageal dilatation

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: FOLFOX and radiotherapy
Oxaliplatin (85mg/m2); Folinic Acid (200mg/m2); 5-FU (400mg/m2-Bolus and 1600mg/m2 over 46h)- once every two weeks for six cycles
Radiazione: radioterapia
Droga: oxaliplatino
Droga: 5-FU
Altri nomi:
  • 5-Fluorouracile
Droga: Acido folinico
Sperimentale: 5-FU / cisplatin and radiotherapy
5-FU (100mg/m2); Cisplatin (75mg/m2)
Radiazione: radioterapia
Droga: cisplatino
Droga: 5-FU
Altri nomi:
  • 5-Fluorouracile

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Percentage of patients who complete the full study treatment (Phase II)
Lasso di tempo: 12 weeks
12 weeks
Endoscopic complete response rate (Phase II)
Lasso di tempo: 12 weeks
12 weeks
Progression-free survival (Phase III)
Lasso di tempo: Until progression
Until progression

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Safety profile as assessed by NCI CTC v2.0 (Phase II)
Lasso di tempo: Total duration of the trial
Total duration of the trial
Overall survival (Phase III)
Lasso di tempo: Total duration of the trial
Total duration of the trial
Complete response rate (Phase III)
Lasso di tempo: Total duration of the trial
Total duration of the trial
Time to treatment failure (Phase III)
Lasso di tempo: Total duration of the trial
Total duration of the trial
Incidence of grade 3-4 toxicities (Phase III)
Lasso di tempo: Total duration of the trial
Total duration of the trial
Quality of life as assessed by EORTC QLQ-C30 (version 3) and EORTC QLQ-OES18 (Phase III)
Lasso di tempo: Total duration of the trial
Total duration of the trial

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

UNICANCER

Investigatori

  • Investigatore principale: Thierry Conroy, MD, Centre Alexis Vautrin

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 2008

Completamento primario (Effettivo)

1 settembre 2011

Completamento dello studio (Effettivo)

1 dicembre 2012

Date di iscrizione allo studio

Primo inviato

12 marzo 2009

Primo inviato che soddisfa i criteri di controllo qualità

12 marzo 2009

Primo Inserito (Stima)

13 marzo 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

18 dicembre 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 dicembre 2015

Ultimo verificato

1 dicembre 2015

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CDR0000595050
  • FRE-FNCLCC- ACCORD-17-0707
  • EU-20848

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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