Chemotherapy Followed By Surgery Vs Radiotherapy Plus Chemotherapy in Patients With Stage IB or II Cervical Cancer
- Conditions
- Cervical Cancer
- Interventions
- Procedure: conventional surgeryProcedure: neoadjuvant chemotherapyRadiation: brachytherapyRadiation: radiation therapy
- Registration Number
- NCT00039338
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 686
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Chemotherapy followed by surgery conventional surgery neoadjuvant chemotherapy (Cisplatin) followed by surgery (radial hysterectomy) Radio-chemotherapy neoadjuvant chemotherapy Concomitant radiotherapy (external radiotherapy combined with external boost or brachytherapy) and chemotherapy (cisplatin) Radio-chemotherapy brachytherapy Concomitant radiotherapy (external radiotherapy combined with external boost or brachytherapy) and chemotherapy (cisplatin) Chemotherapy followed by surgery neoadjuvant chemotherapy neoadjuvant chemotherapy (Cisplatin) followed by surgery (radial hysterectomy) Radio-chemotherapy radiation therapy Concomitant radiotherapy (external radiotherapy combined with external boost or brachytherapy) and chemotherapy (cisplatin) Chemotherapy followed by surgery cisplatin neoadjuvant chemotherapy (Cisplatin) followed by surgery (radial hysterectomy) Radio-chemotherapy cisplatin Concomitant radiotherapy (external radiotherapy combined with external boost or brachytherapy) and chemotherapy (cisplatin)
- Primary Outcome Measures
Name Time Method Overall survival at 5 years 5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (24)
Karl-Franzens-University Graz
🇦🇹Graz, Austria
Ospedale Mauriziano Umberto I
🇮🇹Torino, Italy
Centre Hospitalier Regional de la Citadelle
🇧🇪Liege, Belgium
Kaiser Franz Josef Hospital
🇦🇹Vienna, Austria
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Ospedale di Circolo e Fondazione Macchi
🇮🇹Varese, Italy
Vrije Universiteit Medisch Centrum
🇳🇱Amsterdam, Netherlands
Universitair Medisch Centrum St. Radboud - Nijmegen
🇳🇱Nijmegen, Netherlands
Clinica Universitaria
🇮🇹Turin, Italy
Medisch Spectrum Twente
🇳🇱Enschede, Netherlands
Erasmus MC - Daniel den Hoed Cancer Center
🇳🇱Rotterdam, Netherlands
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Centre Regional Francois Baclesse
🇫🇷Caen, France
Ospedale San Gerardo
🇮🇹Monza, Italy
Academisch Medisch Centrum at University of Amsterdam
🇳🇱Amsterdam, Netherlands
Universitair Medisch Centrum - Academisch Ziekenhuis
🇳🇱Utrecht, Netherlands
Hospitais da Universidade de Coimbra (HUC)
🇵🇹Coimbra, Portugal
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Queen Elizabeth The Queen Mother Hospital
🇬🇧Margate, England, United Kingdom
Istituto Europeo Di Oncologia
🇮🇹Milano, Italy
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori
🇮🇹Naples, Italy
Hospital Universitario San Carlos
🇪🇸Madrid, Spain
Mid Kent Oncology Centre
🇬🇧Maidstone, Kent, United Kingdom
NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, Scotland, United Kingdom