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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Study of Neoadjuvant Cisplatin-Based Chemotherapy Followed By Radical Hysterectomy Versus Standard Therapy With Concurrent Radiotherapy and Cisplatin-Based Chemotherapy in Patients With Stage IB2, IIA, or IIB Cervical Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Active	18 to 75	Other	EORTC-55994 NCT00039338

Trial Description

Purpose:

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.

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.

Eligibility:

Eligibility criteria include the following:

• 18-75 years old
• No previous chemotherapy or radiation therapy
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned to one of two groups.

Patients in group one will receive chemotherapy every 3 weeks for as long as benefit is shown. Within 6 weeks after the last course, patients will undergo surgery to remove the uterus, pelvic lymph nodes, and surrounding tissue. Some patients may then undergo radiation therapy 5 days a week for 5-6 weeks.

Patients in group two will undergo radiation therapy as in group one. At the same time they will receive chemotherapy once a week for up to 6 weeks.

Quality of life will be assessed periodically. Patients will be evaluated every 3 months for 1 year, every 6 months for 4 years, and once a year thereafter.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Fabio Landoni, MD, Study coordinator		Ph: 39-02-5748-954-243
Nicoletta Colombo, MD, Study coordinator		Ph: 39-02-5748-9543 Email: nicoletta.colombo@ieo.it
Stefano Greggi, MD, PhD, Study coordinator		Ph: 39-081-590-3320-390 Email: s.greggi@tin.it
Gemma Kenter, MD, Study coordinator		Ph: 31-71-526-9111 Email: g.g.kenter@lumc.nl

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

Registry Information
Official Title		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
Trial Start Date		2002-03-19
Registered in ClinicalTrials.gov		NCT00039338
Date Submitted to PDQ		2002-04-15
Information Last Verified		2009-07-21

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