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

Alternate Title

Phase II Randomized Study of Adjuvant Radiotherapy Versus Observation in Women With Completely Excised Low-Risk Estrogen Receptor- or Progesterone Receptor-Positive Ductal Carcinoma In Situ of the Breast Receiving Adjuvant Tamoxifen or Anastrozole

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	40 to 70	Other	ICR-DCIS-II EU-20341, NCT00077168

Trial Description

Purpose:

Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether radiation therapy after surgery is effective in preventing a recurrence of ductal carcinoma in situ.

This randomized phase II trial is studying adjuvant radiation therapy to see how well it works compared to observation after surgery in treating women with estrogen receptor positive or progesterone receptor positive ductal carcinoma in situ and are also receiving either tamoxifen or anastrozole.

Eligibility:

Eligibility criteria include the following:

• 40-70 years old
• No more than 6 months since surgery to remove ductal carcinoma in situ
• Received previous tamoxifen or raloxifene for no more than 3 months
• No previous mastectomy
• 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 undergo radiation therapy 5 days a week for 3 or 5 weeks. Patients in group two will undergo observation. All patients will receive either tamoxifen or anastrozole for 5 years.

Quality of life will be assessed periodically. Patients will be evaluated every 6 months for 1 year and once a year 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

Institute of Cancer Research - Sutton

Ronald Kaggwa, Study coordinator		Ph: 44-208-722-4

Registry Information
Official Title		Randomised Trial Testing Observation (No Radiotherapy) Against Radiotherapy In Women With Low-Risk Completely Excised ER Positive Ductal Carcinoma In Situ (DCIS) Of The Breast On Adjuvant Endocrine Therapy
Trial Start Date		2004-04-01
Trial Completion Date		2017-09-30 (estimated)
Registered in ClinicalTrials.gov		NCT00077168
Date Submitted to PDQ		2003-12-11
Information Last Verified		2007-10-14

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