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Radiation Therapy, Chemotherapy, and Cetuximab Followed by Surgery, Chemotherapy, and Cetuximab in Treating Patients With Locally Advanced or Metastatic Rectal Cancer That Can Be Removed by Surgery

7. februar 2020 opdateret af: UNICANCER

Phase II Multicenter Study of the Impact of the Therapeutic Sequence of Radiochemotherapy (50 Gy + Capecitabine + Oxaliplatin + Cetuximab) Followed by Total Mesorectal Excision Surgery Then Post-surgery Chemotherapy (FOLFOX 4 + Cetuximab) in Synchronous Locally Advanced or Metastatic Cancers of the Rectum With Metastases Resectable From the Start (T3-4 Nx or T2 N+ M1).

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as capecitabine, oxaliplatin, fluorouracil, and leucovorin, 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 before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy and cetuximab after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II clinical trial is studying how well giving radiation therapy together with chemotherapy and cetuximab followed by surgery, chemotherapy, and cetuximab works in treating patients with locally advanced or metastatic rectal cancer that can be removed by surgery.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Primary

  • Determine the complete remission rate at 6 months after neoadjuvant radiotherapy, capecitabine, and oxaliplatin (XELOX), and cetuximab followed by surgery, adjuvant FOLFOX 4, and cetuximab in patients with synchronous locally advanced or metastatic cancer of the rectum with resectable metastases (T3-4 Nx or T2 N+ M1).

Secondary

  • Determine progression-free survival.
  • Determine overall survival.
  • Assess toxicities.
  • Evaluate objective response in patients with measurable metastases.
  • Determine the rate of local recurrence.
  • Evaluate the downstaging and downsizing of patients with operable disease.
  • Evaluate surgical complications in patients with operable disease.
  • Evaluate biological markers predictive of response to cetuximab.

OUTLINE: This is a multicenter study.

  • Neoadjuvant therapy: Patients undergo radiotherapy for 5 weeks and receive concurrent oral capecitabine twice daily on days 1-5 of each week and oxaliplatin IV over 2 hours on day 1 of each week (XELOX). Patients also receive cetuximab IV on day 1 of the first week and on days 1-7 of weeks 2-5.
  • Surgery: At 6 weeks after completing chemoradiotherapy, patients with resectable disease undergo surgery comprising total mesorectal excision. Patients with progressive disease, nonresectable tumor, or who require R2 surgery are removed from the study.
  • Adjuvant therapy: Patients who undergo surgery, with or without removal of metastases, receive FOLFOX 4, comprising oxaliplatin IV over 2 hours, fluorouracil IV over 46 hours, and leucovorin calcium IV on day 1, and cetuximab IV. Treatment repeats every 2 weeks for up to 6 courses (approximately 3 months). Patients who have not undergone prior surgical resection of metastases may have surgery to remove metastases after completing this second regimen of chemotherapy.

After completion of study therapy, patients are followed periodically for up to 5 years.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

19

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Frankrig
      • Bordeaux, Frankrig, 33076
        • Institut Bergonie
      • Dijon, Frankrig, 21079
        • Centre de Lutte Contre le Cancer Georges-Francois Leclerc
      • Lille, Frankrig, 59020
        • Centre Oscar Lambret
      • Lyon, Frankrig, 69373
        • Centre Leon Berard
      • Montpellier, Frankrig, 34298
        • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
      • Nice, Frankrig, 06189
        • Centre Antoine Lacassagne
      • Pierre Benite, Frankrig, 69495
        • Centre Hospitalier Lyon Sud
      • Saint Cloud, Frankrig, 92210
        • Centre René Huguenin
      • Vandoeuvre-les-Nancy, Frankrig, 54511
        • Centre Alexis Vautrin
      • Villejuif, Frankrig, F-94805
        • 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 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the rectum

    • Locally advanced (T3-4 Nx) or metastatic (T2 N+ M1) synchronous disease

      • Metastases must be resectable
    • Primary tumor examined by endorectal echography and MRI
  • Measurable disease by thoraco-abdomino-pelvic scanner
  • Disease considered susceptible to treatment with radiotherapy and chemotherapy
  • No diffuse metastases considered nonresectable
  • No acute occlusion not caused by colostomy

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • ECOG performance status 0-2
  • WBC ≥ 4,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 g/dL
  • Creatinine ≤ 130 µmol/L
  • Transaminases ≤ 5 times upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients of must use effective contraception

Exclusion criteria:

  • Contraindication to therapy with capecitabine, oxaliplatin, cetuximab, and/or radiotherapy
  • Impossible to perform translational analyses
  • Uncontrolled severe illness
  • Severe renal or hepatic insufficiency
  • Cardiac insufficiency or symptomatic coronary disease
  • Sensitive peripheral neuropathy
  • Uncontrolled diabetes
  • Other malignancy within the past 10 years except previously treated basal cell skin cancer or carcinoma in situ of the cervix
  • Impossible to participate in study due to geographic, social, or psychiatric reasons
  • Patients who are under supervision or incarcerated

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior anticancer chemotherapy or radiotherapy for this cancer
  • No therapy with coumarin anticoagulants, phenytoin, sorivudine, brivudine, antacids, or allopurinol
  • No concurrent participation in another therapeutic study or receiving another experimental drug

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: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Complete remission at ≥ 6 months by abdomino-pelvic-thoracic scan and a pelvic MRI

Sekundære resultatmål

Resultatmål
Progressionsfri overlevelse
Samlet overlevelse
Seksuel funktion
Sen toksicitet
Kirurgiske komplikationer
Sphincter funktion
Preoperative clinical response
Early toxicity before surgery
Early toxicity due to surgery (mortality at 30 days, postoperative complications, surgical recovery)
Late radiotherapy toxicity by CTC AE v. 3.0
Objective response of measurable metastases by RECIST
Downstaging and downsizing of patients with operable disease
Predictive biomarkers of response to cetuximab

Samarbejdspartnere og efterforskere

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

Sponsor

UNICANCER

Efterforskere

  • Ledende efterforsker: David Azria, MD, PhD, Institut du Cancer de Montpellier - Val d'aurelle

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 (Faktiske)

29. oktober 2007

Primær færdiggørelse (Faktiske)

29. januar 2010

Studieafslutning (Faktiske)

29. januar 2010

Datoer for studieregistrering

Først indsendt

5. oktober 2007

Først indsendt, der opfyldte QC-kriterier

5. oktober 2007

Først opslået (Skøn)

8. oktober 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. februar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. februar 2020

Sidst verificeret

1. februar 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR0000565937
  • FRE-FNCLCC-ACCORD-14/0604 (Anden identifikator: FNCLCC)
  • EU-20759
  • 2006-003336-30 (EudraCT nummer)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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