Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

European Organization for Research and Treatment of Cancer

Fabio Landoni

Nicoletta Colombo

Stefano Greggi

Gemma G. Kenter

Argentina
	Buenos Aires
	Hospital de Clinicas "Jose De San Martin"
		Contact Person	Ph: 54-1-5950-8000
Austria
	Graz
	Karl-Franzens-University Graz
		Contact Person	Ph: 43-316-380-4100
	Vienna
	Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital
		Contact Person	Ph: 43-1-601-9152
Belgium
	Edegem
	Universitair Ziekenhuis Antwerpen
		Contact Person	Ph: 32-03-821-3375
	Leuven
	U.Z. Gasthuisberg
		Contact Person	Ph: 32-16-332-211
	Liege
	Centre Hospitalier Regional de la Citadelle
		Contact Person	Ph: 32-4-225-6111
Italy
	Milano
	European Institute of Oncology
		Contact Person	Ph: 39-2-574-891
	Monza
	Ospedale San Gerardo
		Contact Person	Ph: 39-039-2331
	Naples
	Istituto Nazionale per lo Studio e la Cura dei Tumori
		Contact Person	Ph: 39-81-590-3269
	Torino
	Azienda Sanitaria Ospedaliera Ordine Mauriziano
		Contact Person	Ph: 39-11-508-1111
	Turin
	Clinica Universitaria
		Contact Person	Ph: 39-11-434-5345
	Varese
	Ospedale di Circolo e Fondazione Macchi
		Contact Person	Ph: 39-0332-278-376
Netherlands
	Amsterdam
	Academisch Medisch Centrum at University of Amsterdam
		Contact Person	Ph: 31-20-566-9111
	Vrije Universiteit Medisch Centrum
		Contact Person	Ph: 31-20-444-4300
	Enschede
	Medisch Spectrum Twente
		Contact Person	Ph: 31-53-487-2000
	Leiden
	Leiden University Medical Center
		Contact Person	Ph: 31-71-526-911
	Nijmegen
	Universitair Medisch Centrum St. Radboud - Nijmegen
		Contact Person	Ph: 31-80-361-1111
	Rotterdam
	Daniel Den Hoed Cancer Center at Erasmus Medical Center
		Contact Person	Ph: 31-10-439-1911
	Utrecht
	University Medical Center Utrecht
		Contact Person	Ph: 31-30-250-6266
Poland
	Gdansk
	Medical University of Gdansk
		Contact Person	Ph: 48-58-349-2222
Portugal
	Coimbra
	Hospitais da Universidade de Coimbra (HUC)
		Contact Person	Ph: 351-39-403-939
Spain
	Madrid
	Hospital Universitario San Carlos
		Contact Person	Ph: 34-330-3000
United Kingdom
England
	Margate
	Queen Elizabeth The Queen Mother Hospital
		Contact Person	Ph: 44-1843-225-544
Scotland
	Glasgow
	Gartnavel General Hospital
		Contact Person	Ph: 44-141-211-3242
	Western Infirmary
		Contact Person	Ph: 44-141-330-4006

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00039338
Information obtained from ClinicalTrials.gov on December 19, 2011

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