Conventional Versus Hypofractionated Radiotherapy in Node Positive Breast Cancer

Last updated: May 29, 2016
Sponsor: Ain Shams University
Overall Status: Active - Recruiting

Phase

3

Condition

Breast Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT02690636
Cure and More3
  • Ages 20-65
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. ECOG. (Eastern Cooperative Oncology Group): 0-2

  2. Histologic documentation of invasive duct or lobular adenocarcinoma of the breast

  3. If neoadjuvant chemotherapy was NOT administered: pathologic T1-3, N1-2 followingdefinitive surgery

  4. If neoadjuvant chemotherapy was administered, pathology from the definitive surgerymust confirm pathologic T1-3, N1-2 disease and also meet one of the followingcriteria: Clinical T1-3, N1-2 or Pathologic confirmation of axillary nodal involvement atpresentation (ie, before neoadjuvant therapy) based on any of the following: Positivefine-needle aspiration (FNA), Positive core needle biopsy.

  5. Complete resection of known breast disease by one of the following surgeriesLumpectomy with axillary lymph node dissection with no more than 12 resected lymphnodes. 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 growthfactor receptor 2) testing performed on the primary breast tumor; when applicable, testingmust have been performed before receiving neoadjuvant chemotherapy.

6-Margins of the resected specimen must be histologically free of invasive tumor and ductalcarcinoma 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 adjuvantchemotherapy 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 thelast 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 ofpregnancy prevention for the duration of study treatment 11-Ability to understand andwillingness to sign the consent form written in Arabic

Exclusion

Exclusion Criteria:

  1. Patients with surgical margins less than or equal to 2mm.

  2. Patients with axillary dissection of more than 12 lymph nodes due to high incidence ofarm lymphedema.

  3. Women with Huge pendulous breast.

  4. Patients with bad breast conservative surgery ( Surgery that impair the cosmeticoutcome before starting radiotherapy).

  5. T4 tumors including inflammatory breast cancer.

  6. Known definitive clinical or radiologic evidence of metastatic disease.

  7. Patients re operated for microscopic positive margins after definitive surgery.

  8. Previous radiation therapy for the currently diagnosed breast cancer prior to studyenrollment

  9. History of ipsilateral or contralateral breast or thoracic radiotherapy for anycondition

  10. History of ipsilateral or contralateral axillary surgery for any condition

  11. History of lymphedema involving the ipsilateral or contralateral arm at present or atany time in the past

  12. Active collagen vascular disease, specifically dermatomyositis with a creatinephosphokinase (CPK) level above normal or with an active skin rash, systemic lupuserythematosis, or scleroderma.

  13. Pregnancy or breastfeeding

  14. Second primary cancer.

Study Design

Total Participants: 500
Study Start date:
January 01, 2016
Estimated Completion Date:
April 30, 2021

Study 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.

Connect with a study center

  • Mahmoud Ellithy

    Cairo, Abbasia 14031
    Egypt

    Active - Recruiting

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