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Chemotherapy Followed By Surgery Vs Radiotherapy Plus Chemotherapy in Patients With Stage IB or II Cervical Cancer

2. december 2016 opdateret af: European Organisation for Research and Treatment of Cancer - EORTC

Randomized Phase III Study Of Neoadjuvant Chemotherapy Followed By Surgery Vs. Concomitant Radiotherapy And Chemotherapy In FIGO Ib2, IIa>4 cm or IIb Cervical Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed during surgery. Radiation therapy uses high-energy x-rays to kill tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known whether chemotherapy is more effective followed by surgery or combined with radiation therapy in treating cervical cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy followed by radical hysterectomy with that of chemotherapy plus radiation therapy in treating patients who have stage IB or stage II cervical cancer.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

  • Compare the overall and progression-free survival of patients with stage IB2, IIA, or IIB cervical cancer treated with neoadjuvant cisplatin-based chemotherapy followed by radical hysterectomy vs standard therapy comprising concurrent radiotherapy and cisplatin-based chemotherapy.
  • Compare the toxicity of these regimens in these patients.
  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, FIGO stage, age (18 to 50 vs 51 to 75), and histological subtype (adenomatous vs non-adenomatous component). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive neoadjuvant cisplatin-based chemotherapy on day 1. Treatment repeats every 21 days. Within 6 weeks after the last chemotherapy course, patients undergo a type III-V Piver-Rutledge radical hysterectomy. Patients with positive lymph nodes or tumor invasion into the parametria or less than 5 mm from the resection borders after surgery receive standard adjuvant external beam radiotherapy once daily, 5 days a week, for 5-5.6 weeks (25-28 treatment days) followed by external boost radiotherapy or brachytherapy for 1 or 2 days.
  • Arm II: Patients receive standard therapy comprising radiotherapy as in arm I concurrently with cisplatin-based chemotherapy once weekly for 6 weeks. Adjuvant hysterectomy is allowed, but not recommended, in case of histologically proven residual tumor.

Treatment in both arms continues in the absence of disease progression or unacceptable toxicity. For patients in both arms, cisplatin may be combined with other chemotherapeutics as long as the minimum platinum dose is given.

Quality of life is assessed at baseline and at 6, 12, 18, and 24 months.

Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 686 patients (343 per treatment arm) will be accrued for this study within 3.8 years.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

686

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Belgien
      • Edegem, Belgien
        • Universitair Ziekenhuis Antwerpen
      • Leuven, Belgien
        • U.Z. Gasthuisberg
      • Liege, Belgien, 4000
        • Centre Hospitalier Regional de la Citadelle
  • Det Forenede Kongerige
      • Maidstone, Kent, Det Forenede Kongerige
        • Mid Kent Oncology Centre
    • England
      • Margate, England, Det Forenede Kongerige
        • Queen Elizabeth the Queen Mother Hospital
    • Scotland
      • Glasgow, Scotland, Det Forenede Kongerige
        • NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre
  • Frankrig
      • Caen, Frankrig
        • Centre Regional Francois Baclesse
  • Holland
      • Amsterdam, Holland, 1105 AZ
        • Academisch Medisch Centrum at University of Amsterdam
      • Amsterdam, Holland
        • Vrije Universiteit Medisch Centrum
      • Enschede, Holland
        • Medisch Spectrum Twente
      • Leiden, Holland
        • Leiden University Medical Center
      • Nijmegen, Holland
        • Universitair Medisch Centrum St. Radboud - Nijmegen
      • Rotterdam, Holland, 3008 AE
        • Erasmus MC - Daniel den Hoed Cancer Center
      • Utrecht, Holland
        • Universitair Medisch Centrum - Academisch Ziekenhuis
  • Italien
      • Milano, Italien
        • Istituto Europeo di Oncologia
      • Monza, Italien
        • Ospedale San Gerardo
      • Naples, Italien
        • Istituto Nazionale per lo Studio e la Cura dei Tumori
      • Torino, Italien, 10128
        • Ospedale Mauriziano Umberto I
      • Turin, Italien, 10126
        • Clinica Universitaria
      • Varese, Italien
        • Ospedale di Circolo e Fondazione Macchi
  • Portugal
      • Coimbra, Portugal
        • Hospitais da Universidade de Coimbra (HUC)
  • Spanien
      • Madrid, Spanien
        • Hospital Universitario San Carlos
  • Østrig
      • Graz, Østrig
        • Karl-Franzens-University Graz
      • Vienna, Østrig
        • Kaiser Franz Josef Hospital

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

Kvinde

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically confirmed cervical cancer, including the following subtypes:

    • Squamous cell carcinoma
    • Adenosquamous cell carcinoma
    • Adenocarcinoma (excluding small cell, clear cell, and other rare variants of the classical adenocarcinoma)
  • FIGO stage IB2, IIA (greater than 4 cm), or IIB

PATIENT CHARACTERISTICS:

Age:

  • 18 to 75

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Bilirubin less than 1.46 mg/dL

Renal:

  • Creatinine clearance greater than 60 mL/min

Other:

  • No other prior or concurrent malignancy except adequately treated basal cell skin cancer
  • No psychological, familial, sociological, or geographical condition that would preclude study
  • Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • Not specified

Other:

  • No other concurrent anticancer agent

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: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Chemotherapy followed by surgery
neoadjuvant chemotherapy (Cisplatin) followed by surgery (radial hysterectomy)
Procedure: conventional surgery
Radial hysterectomy
Procedure: neoadjuvant chemotherapy
Experimental arm: minimal cumulative cisplatin dose of 225 mg/m2. Comparator arm: cumulative cisplatin dose of 200-240 mg/m2.
Medicin: cisplatin
Minimal cumulative 225 mg/m2 (experimental arm). Cumulative 200-240 mg/m2 (comparator arm).
Aktiv komparator: Radio-chemotherapy
Concomitant radiotherapy (external radiotherapy combined with external boost or brachytherapy) and chemotherapy (cisplatin)
Procedure: neoadjuvant chemotherapy
Experimental arm: minimal cumulative cisplatin dose of 225 mg/m2. Comparator arm: cumulative cisplatin dose of 200-240 mg/m2.
Medicin: cisplatin
Minimal cumulative 225 mg/m2 (experimental arm). Cumulative 200-240 mg/m2 (comparator arm).
Stråling: brachytherapy
Brachytherapy at the end of external radiation. Minimal total dose (external with or without external boost + brachytherapy) of 75 Gy EQD2 to point A. Overall treatment less than 50 days.
Stråling: radiation therapy
Between 45-50 Gy, in fractions of 1.8 to 2 Gy.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Samlet overlevelse ved 5 år
Tidsramme: 5 år
5 år

Samarbejdspartnere og efterforskere

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

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Efterforskere

  • Studiestol: Fabio Landoni, MD, Istituto Europeo Di Oncologia, Milano
  • Studiestol: Alessandro Colombo, MD, Ospedale Alessandro Manzoni, Lecco
  • Studiestol: Stefano Greggi, MD, PhD, Istituto Nazionale per lo Studio e la Cura dei Tumori, Napoli
  • Studiestol: Gemma G. Kenter, MD, Academisch Medisch Centrum - Universiteit van Amsterdam

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. marts 2002

Primær færdiggørelse (Forventet)

1. juli 2019

Datoer for studieregistrering

Først indsendt

6. juni 2002

Først indsendt, der opfyldte QC-kriterier

26. januar 2003

Først opslået (Skøn)

27. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. december 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. december 2016

Sidst verificeret

1. december 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EORTC-55994
  • 2008-003396-52 (EudraCT nummer)

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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Sponsor / samarbejdspartnere

Placeringer

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