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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 Concurrent Chemoradiotherapy Followed By Adjuvant Chemotherapy Versus Pelvic Radiotherapy Alone in Patients With High-Risk Stage IB-III Endometrial Carcinoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active Not specified Other CKTO-2006-04 ISRCTN14387080, CKTO-PORTEC-3, EU-20664, NCT00411138

Trial Description

Purpose:

Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving chemotherapy together with radiation therapy is more effective than giving radiation therapy alone in treating endometrial cancer.

This randomized phase III trial is studying chemotherapy and radiation therapy to see how well they work compared with radiation therapy alone in treating patients with high-risk, stage I, stage II, or stage III endometrial cancer.

Eligibility:

Eligibility criteria include the following:

• Has undergone surgery to remove the uterus, cervix, both ovaries, and both fallopian tubes within the past 8 weeks
• No uterine sarcoma
• No previous radiation therapy to the pelvis
• No previous hormone therapy or chemotherapy for this tumor
• 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 (have an equal chance of being placed) to one of two treatment groups.

Patients in group one will receive a 1- to 2-hour infusion of cisplatin in weeks 1 and 4. They will also undergo radiation therapy to the pelvis 5 days a week for up to 6 weeks. Beginning at least 3 weeks after finishing chemotherapy and radiation therapy, patients will receive a 3-hour infusion of paclitaxel and a 1-hour infusion of carboplatin. Treatment with paclitaxel and carboplatin may repeat every 3 weeks for up to four courses.

Patients in group two will undergo radiation therapy to the pelvis 5 days a week for up to 6 weeks.

In both groups, some patients will undergo internal radiation to the vagina.

Quality of life will be assessed before beginning treatment, after finishing radiation therapy, after finishing paclitaxel and carboplatin, at 6 months, and once a year for 5 years.

After finishing treatment, patients will be evaluated periodically for up to 10 years.

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

Leiden University Medical Center

Carien Creutzberg, MD, PhD, Protocol chair		Ph: 31-71-526-3027 Email: c.l.creutzberg@lumc.nl

Netherlands
	Leiden
	Leiden University Medical Center
		Carien Creutzberg, MD, PhD	Ph:  31-71-526-3027
			Email: c.l.creutzberg@lumc.nl

Registry Information
Official Title		Randomized Phase III Trial Comparing Concurrent Chemoradiation and Adjuvant Chemotherapy with Pelvic Radiation Alone in High Risk and Advanced Stage Endometrial Carcinoma: PORTEC-3
Trial Start Date		2006-10-16
Trial Completion Date		2012-10-16 (estimated)
Registered in ClinicalTrials.gov		NCT00411138
Date Submitted to PDQ		2006-11-09
Information Last Verified		2007-02-13