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Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer

Sponsored by Medical Research Council

About this trial

Last updated 12 years ago

Study ID

CDR0000067661

Status

Completed

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
18+ Years
Female
Female

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 21 years ago

What is this trial about?

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of radiation therapy is more effective following surgery for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of radiation therapy following surgery in treating women who have early stage breast cancer.

What are the Participation Requirements?

DISEASE CHARACTERISTICS:

- Histologically confirmed invasive unilateral breast cancer

- T1-3, N0-1, M0 at presentation

- Complete macroscopic excision of tumor by breast conserving surgery or mastectomy

- No immediate breast reconstruction

- No requirement for axillary radiotherapy after greater than a Level 1 axillary
dissection or after greater than 10 lymph nodes have been removed

- Not enrolled on SECRAB or OSCAR trials

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Sex:

- Female

Menopausal status:

- Not specified

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

PRIOR CONCURRENT THERAPY:

- Prior neoadjuvant, or primary medical, therapy is allowed provided subsequent surgery
confirms complete macroscopic excision of residual primary tumor

Biologic therapy:

- Not specified

Chemotherapy:

- At least 2 weeks since prior cytotoxic agents

- No concurrent chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

Surgery:

- See Disease Characteristics

Locations

Location

Status