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Radiation Therapy, Cisplatin, Fluorouracil, and Cetuximab in Treating Patients With Locally Advanced Anal Cancer

7 febbraio 2020 aggiornato da: UNICANCER

Phase II Nonrandomized Multicenter Study of the Impact of Radiochemotherapy (65 Gy + Cisplatin + 5FU) Combined With Cetuximab in Patients Presenting With Locally Advanced Anal Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving radiation therapy together with combination chemotherapy and cetuximab may kill more tumor cells.

PURPOSE: This phase II trial is studying giving radiation therapy together with cisplatin, fluorouracil, and cetuximab to see how well it works in treating patients with locally advanced anal cancer.

Panoramica dello studio

Stato

Terminato

Condizioni

Cancro anale

Intervento / Trattamento

Descrizione dettagliata

OBJECTIVES:

Primary

Evaluate the objective response (complete and partial) 8 weeks after completion of study treatment comprising radiotherapy, chemotherapy (fluorouracil and cisplatin), and cetuximab followed by additional radiotherapy in patients with locally advanced anal cancer.

Secondary

Evaluate colostomy-free survival.
Evaluate the local control rate (objective response and stabilization) at 8 weeks.
Evaluate relapse-free survival at 5 years.
Evaluate the intermediate objective response at the end of week 5 of radiotherapy.
Evaluate overall survival at 5 years.
Evaluate the duration of response.
Evaluate acute toxicities according to CTCAE v3.0.
Evaluate late toxicities at 5 years according to CTCAE v3.0.
Study the tumor markers associated with response (survival without relapse) and toxicity.
Study the genotypes of Fc-receptor immunoglobulins (FCGR2A and FCGR3) and their association with skin toxicity, objective survival, and relapse-free survival.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV on days 0, 7, 14, 21, 28, and 35; fluorouracil IV on days 7-10 and 35-38; and cisplatin IV over 2 hours on days 7 and 35. Beginning on day 7, patients also undergo radiotherapy 5 days a week for 5 weeks (weeks 2-6). Two weeks after finishing this treatment, patients undergo additional radiotherapy* 5 days a week for 2 weeks (weeks 9 and 10).

NOTE: *Some patients may undergo brachytherapy.

Blood and tissue samples are collected for further analysis.

After completion of study treatment, patients are followed up for 4 years.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

Fase

Fase 2

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
- - Bordeaux, Francia, 33076
    - Institut Bergonie
  - Brest, Francia, 29609
    - CHU Hopital A. Morvan
  - Caen, Francia, 14076
    - Centre Regional Francois Baclesse
  - La Roche Sur Yon, Francia, F-85025
    - Centre Hospitalier departemental
  - Lille, Francia, 59020
    - Centre Oscar Lambret
  - Limoges, Francia, 87042
    - Centre Hospital Regional Universitaire de Limoges
  - Lyon, Francia, 69373
    - Centre Léon Bérard
  - Montpellier, Francia, 34298
    - Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
  - Nantes-Saint Herblain, Francia, 44805
    - Centre Regional Rene Gauducheau
  - Nice, Francia, 06189
    - Centre Antoine Lacassagne
  - Paris, Francia, 75970
    - Hôpital Tenon
  - Paris, Francia, 75475
    - Hôpital Saint-Louis
  - Paris, Francia, 75248
    - Institut Curie Hopital
  - Pierre Benite, Francia, 69495
    - Centre Hospitalier LYON SUD
  - Rouen, Francia, 76031
    - Hôpital Charles Nicolle
  - Saint-Gregoire, Francia, 35768
    - Centre hospitalier Privé Saint-Grégoire
  - Toulouse, Francia, 31078
    - Clinique du Parc
  - Toulouse, Francia, 31300
    - Groupe Oncorad Garonne
  - 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

Da 18 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

DISEASE CHARACTERISTICS:

Histologically confirmed anal cancer
- Squamous cell disease
- Locally advanced, non-metastatic disease
- One of the following clinical TNM stages:
  - T2, N0, M0 (largest diameter ≥ 3 cm)
  - T3-T4, N0, M0
  - Any T, N1-N3, M0
No undifferentiated small cell carcinoma or adenocarcinoma
Measurable disease according to RECIST criteria
Undergone endorectal ultrasound or MRI to evaluate the primary tumor
Undergone thoraco-abdomino-pelvic scan to evaluate tumor extension
Disease suitable to receive radiotherapy and chemotherapy

PATIENT CHARACTERISTICS:

ECOG performance status 0-1
Leukocytes ≥ 4,000/mm^3
ANC ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 10 g/dL
Creatinine clearance > 60 mL/min
ALT and AST ≤ 5 times upper limit of normal (ULN)
Alkaline phosphatase ≤ 2.5 times ULN
Total bilirubin ≤ 1.5 times ULN
Not pregnant or nursing
Negative pregnancy test
No history of cancer within the past 8 years except for in situ cervical cancer or previously treated basal cell carcinoma of the skin
No contraindications to any component of study therapy
No serious uncontrolled illness
No symptomatic grade 1 angina pectoris or angina pectoris ≥ grade 2
No congestive heart failure
No peripheral sensory neuropathy
No uncontrolled diabetes
No HIV positivity
No geographical, social, or psychological situations that preclude medical follow up
Affiliated with a social security system
No patient deprived of liberty or under trusteeship

PRIOR CONCURRENT THERAPY:

Patients with a diverting colostomy are eligible
No prior excision of this tumor
No prior chemotherapy or radiotherapy for the treatment of this cancer or any other history of radiotherapy or pelvic brachytherapy
No concurrent coumarin anticoagulants, phenytoin, sorivudine or brivudine, antacids, or allopurinol
Not registered in another clinical trial with an experimental drug

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: N / A
Modello interventistico: Assegnazione di gruppo singolo
Mascheramento: Nessuno (etichetta aperta)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Objective response (complete and partial) according to RECIST criteria at 8 weeks after completion of study treatment

Misure di risultato secondarie

Misura del risultato
Durata della risposta obiettiva
Survival rate at 3 and 5 years
Colostomy-free survival at 3 and 5 years

Collaboratori e investigatori

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

Sponsor

UNICANCER

Investigatori

Investigatore principale: Eric Deutsch, MD, Gustave Roussy, Cancer Campus, Grand Paris

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 2009

Completamento primario (Effettivo)

26 novembre 2010

Completamento dello studio (Effettivo)

26 novembre 2010

Date di iscrizione allo studio

Primo inviato

7 agosto 2009

Primo inviato che soddisfa i criteri di controllo qualità