Chemotherapy Followed By Surgery Vs Radiotherapy Plus Chemotherapy in Patients With Stage IB or II Cervical Cancer
NCT ID: NCT00039338
Last Updated: 2016-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
686 participants
INTERVENTIONAL
2002-03-31
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Chemotherapy followed by surgery
neoadjuvant chemotherapy (Cisplatin) followed by surgery (radial hysterectomy)
conventional surgery
Radial hysterectomy
neoadjuvant chemotherapy
Experimental arm: minimal cumulative cisplatin dose of 225 mg/m2. Comparator arm: cumulative cisplatin dose of 200-240 mg/m2.
cisplatin
Minimal cumulative 225 mg/m2 (experimental arm). Cumulative 200-240 mg/m2 (comparator arm).
Radio-chemotherapy
Concomitant radiotherapy (external radiotherapy combined with external boost or brachytherapy) and chemotherapy (cisplatin)
neoadjuvant chemotherapy
Experimental arm: minimal cumulative cisplatin dose of 225 mg/m2. Comparator arm: cumulative cisplatin dose of 200-240 mg/m2.
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.
radiation therapy
Between 45-50 Gy, in fractions of 1.8 to 2 Gy.
cisplatin
Minimal cumulative 225 mg/m2 (experimental arm). Cumulative 200-240 mg/m2 (comparator arm).
Interventions
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conventional surgery
Radial hysterectomy
neoadjuvant chemotherapy
Experimental arm: minimal cumulative cisplatin dose of 225 mg/m2. Comparator arm: cumulative cisplatin dose of 200-240 mg/m2.
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.
radiation therapy
Between 45-50 Gy, in fractions of 1.8 to 2 Gy.
cisplatin
Minimal cumulative 225 mg/m2 (experimental arm). Cumulative 200-240 mg/m2 (comparator arm).
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
75 Years
FEMALE
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Fabio Landoni, MD
Role: STUDY_CHAIR
Istituto Europeo Di Oncologia, Milano
Alessandro Colombo, MD
Role: STUDY_CHAIR
Ospedale Alessandro Manzoni, Lecco
Stefano Greggi, MD, PhD
Role: STUDY_CHAIR
Istituto Nazionale per lo Studio e la Cura dei Tumori, Napoli
Gemma G. Kenter, MD
Role: STUDY_CHAIR
Academisch Medisch Centrum - Universiteit van Amsterdam
Locations
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Karl-Franzens-University Graz
Graz, , Austria
Kaiser Franz Josef Hospital
Vienna, , Austria
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
Centre Hospitalier Regional de la Citadelle
Liège, , Belgium
Centre Regional Francois Baclesse
Caen, , France
Istituto Europeo Di Oncologia
Milan, , Italy
Ospedale San Gerardo
Monza, , Italy
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori
Naples, , Italy
Ospedale Mauriziano Umberto I
Torino, , Italy
Clinica Universitaria
Turin, , Italy
Ospedale di Circolo e Fondazione Macchi
Varese, , Italy
Academisch Medisch Centrum at University of Amsterdam
Amsterdam, , Netherlands
Vrije Universiteit Medisch Centrum
Amsterdam, , Netherlands
Medisch Spectrum Twente
Enschede, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Universitair Medisch Centrum St. Radboud - Nijmegen
Nijmegen, , Netherlands
Erasmus MC - Daniel den Hoed Cancer Center
Rotterdam, , Netherlands
Universitair Medisch Centrum - Academisch Ziekenhuis
Utrecht, , Netherlands
Hospitais da Universidade de Coimbra (HUC)
Coimbra, , Portugal
Hospital Universitario San Carlos
Madrid, , Spain
Queen Elizabeth The Queen Mother Hospital
Margate, England, United Kingdom
NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom
Mid Kent Oncology Centre
Maidstone, Kent, , United Kingdom
Countries
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References
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Kenter GG, Greggi S, Vergote I, Katsaros D, Kobierski J, van Doorn H, Landoni F, van der Velden J, Reed N, Coens C, van Luijk I, Colombo N, Steen-Banasik EV, Ottevanger N, Casado A; EORTC-55994 Study Group. Randomized Phase III Study Comparing Neoadjuvant Chemotherapy Followed by Surgery Versus Chemoradiation in Stage IB2-IIB Cervical Cancer: EORTC-55994. J Clin Oncol. 2023 Nov 10;41(32):5035-5043. doi: 10.1200/JCO.22.02852. Epub 2023 Sep 1.
Other Identifiers
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2008-003396-52
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EORTC-55994
Identifier Type: -
Identifier Source: org_study_id