Conventional Versus Hypofractionated Radiotherapy in Node Positive Breast Cancer

NCT ID: NCT02690636

Last Updated: 2016-06-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2021-04-30

Brief 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.

Detailed 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional

The patients will receive adjuvant radiotherapy conventionally fractionated 5000 cgy fractionated by 200cgy daily fractions, five fractions per week over 5 weeks with an additional 200cgy daily for five days as boost for patients with breast conservative surgery.

Group Type: ACTIVE_COMPARATOR

radiotherapy

Intervention Type: RADIATION

daily fractions, five fractions per week.

Hypofractionated

The patients will receive adjuvant radiotherapy hypofractionated 266cgy daily fractions, five fractions per week for total 16 fractions and an additional five daily fractions will be added as boost for patients with breast conservative surgery.

Group Type: EXPERIMENTAL

radiotherapy

Intervention Type: RADIATION

daily fractions, five fractions per week.

Interventions

radiotherapy

daily fractions, five fractions per week.

Intervention Type: RADIATION

Eligibility Criteria

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 following definitive surgery

4. 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.

5. 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

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 of arm lymphedema.

3. Women with Huge pendulous breast.

4. Patients with bad breast conservative surgery ( Surgery that impair the cosmetic outcome 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 study enrollment

9. History of ipsilateral or contralateral breast or thoracic radiotherapy for any condition

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

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

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

13. Pregnancy or breastfeeding

14. Second primary cancer.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mit Ghamr Oncology Center

OTHER

Sponsor Role: collaborator

Clinical Oncology department. Elmansoura University.

UNKNOWN

Sponsor Role: collaborator

Zagazig University

OTHER_GOV

Sponsor Role: collaborator

Assiut University

OTHER

Sponsor Role: collaborator

Tanta University

OTHER

Sponsor Role: collaborator

Al-Azhar University

OTHER

Sponsor Role: collaborator

Medical Research Institute. Department of Cancer Management and Research.

UNKNOWN

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: collaborator

Clinical Oncology Department. Banha University.

UNKNOWN

Sponsor Role: collaborator

Ayadi El Mostakbal Cancer Center. Alexandria.

UNKNOWN

Sponsor Role: collaborator

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Ellithy

Associate professor of clinical oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mahmoud Ellithy, Phd

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Mahmoud Ellithy

Cairo, Abbasia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mahmoud Ellithy, Phd

Role: CONTACT

ellithym@med.asu.edu.eg

01000069694 ext. 002

Facility Contacts

Mahmoud Ellithy, Phd

Role: primary

ellithym@med.asu.edu.eg

01000069694 ext. 002

Other Identifiers

Cure and More3

Identifier Type: -

Identifier Source: org_study_id