Status and phase
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About
Breast cancer patients operated with modified radical mastectomy or breast conservative surgery will be randomized for either adjuvant conventional radiotherapy versus hypofractionated radiotherapy for chest wall and axilla or breast and axilla.
The patients will be recruited for one year and will be followed for 5 years by monitoring local recurrence, cosmetic outcomes, health economic perspectives, and arm lymph edema.
Full description
The investigators hypothesize that hypofractionated radiotherapy in node positive breast cancer is equally effective and safe as conventional fractionated radiotherapy. Breast cancer patients with pathological positive lymph nodes (N1 - N2) operated with modified radical mastectomy will be randomized 1:1 and also those with breast conservative surgery with positive lymph nodes will be randomized 1:1 for receiving either adjuvant conventional radiotherapy 200cgy x 25 fractions with 200cgy x 5 fractions boost for those with intact breast versus hypofractionated radiotherapy 266cgyx16 fractions and 266 cgy x 4 fractions boost for those with intact breast. The patients will be followed for 5 years to monitor locoregional recurrence, cosmetic outcomes, ipsilateral arm lymph edema. Health economic perspectives will be monitored by calculating cost effective analysis for both treatment plans.
Enrollment
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Inclusion criteria
ECOG. (Eastern Cooperative Oncology Group): 0-2
Histologic documentation of invasive duct or lobular adenocarcinoma of the breast
If neoadjuvant chemotherapy was NOT administered: pathologic T1-3, N1-2 following definitive surgery
If neoadjuvant chemotherapy was administered, pathology from the definitive surgery must confirm pathologic T1-3, N1-2 disease and also meet one of the following criteria:
Clinical T1-3, N1-2 or Pathologic confirmation of axillary nodal involvement at presentation (ie, before neoadjuvant therapy) based on any of the following: Positive fine-needle aspiration (FNA), Positive core needle biopsy.
Complete resection of known breast disease by one of the following surgeries Lumpectomy with axillary lymph node dissection with no more than 12 resected lymph nodes.
Mastectomy and axillary lymph node dissection with no more than 12 resected lymph nodes.
5- ER(estrogen-receptor), PR (progesterone-receptor), and HER2(human epidermal growth factor receptor 2) testing performed on the primary breast tumor; when applicable, testing must have been performed before receiving neoadjuvant chemotherapy.
6-Margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the pathologist.
7-The surgical wound should be completely healed without any signs of infection.
8-Interval between the last surgery for breast cancer or the completion of adjuvant chemotherapy and study enrollment must be ≤ 56 days (ie, a maximum of 8 weeks).
9-If adjuvant chemotherapy is received there should be at least 10 days gap between the last day of chemotherapy and the enrollment in the study to avoid skin toxicity.
10-Women of child-bearing potential must agree to use a medically accepted form of pregnancy prevention for the duration of study treatment 11-Ability to understand and willingness to sign the consent form written in Arabic
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
500 participants in 2 patient groups
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Central trial contact
Mahmoud Ellithy, Phd
Data sourced from clinicaltrials.gov
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