Swebcg 91:A RT. Breast Conserving Surgery With or Without Radiotherapy for Breast Cancer Patients

Region Skane

Status: Active, not recruiting

Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Treatments: Radiation: postoperative radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06637202

LU 80/90

Details and patient eligibility

About

The main goal of the trial was to analyse the value of radiotherapy after breast conserving surgery for patients with breast cancer, and to find groups of patients where the treatment could be omitted.

Full description

The trial recruited patients between 1991-1996, and the primary outcome in terms of recurrences has been updated through the years since then. Tumour material has been collected in order to study prognostic and predictive factors for breast cancer patients that are treated today. Late side effects of the treatment are studied.

Enrollment: 1,187 patients

Sex: Female

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• female
• not over the age of 75 years
• operated because of stage 1-2 invasive adenocarcinoma of the breast
• radical excision of the tumour

Exclusion criteria

• earlier cancer except cancer in situ of the cervix or skin
• distant metastases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,187 participants in 2 patient groups

postoperative radiotherapy

Active Comparator group

Description:

Patients were treated with radiotherapy to 50 Gy in 25 fractions

Treatment:

Radiation: postoperative radiotherapy

control

No Intervention group

Description:

Patients received no further treatment after surgery