Spots Global Cancer Trial Database for Hypofractionated Versus Conventional Fractionation Radiotherapy

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Hypofractionated Versus Conventional Fractionation Radiotherapy

Official Title: Hypofractionated Versus Conventional Fractionation Radiation After Conservative Surgery or Mastectomy With Irradiation of Lymph Node Drainage: a Phase II Randomized Clinical Trial for the Evaluation of Acute Toxicity

Study ID: NCT04015531

Conditions

Breast Cancer

Radiation Toxicity

Interventions

Conventional radiotherapy

Hypofractionated radiotherapy

Study Description

Brief Summary: This study was designed to evaluate the acute toxicity and quality of life of hypofractionated radiation versus conventional when regional node irradiation is indicated after breast-conserving surgery or mastectomy.

Detailed Description: Investigators hypothesize that hypofractionated radiotherapy is equal effective and safe as conventional radiotherapy in breast cancer patients undergoing regional nodal irradiation. Eligible breast cancer patients are randomized 1:1 into the following two groups: 1. Hypofractionated therapy: 40 Gy in 15 fractions of 2.67 Gy in breast or chest wall and nodal drainage with Concurrent boost 48.0 Gy / 3.2 Gy daily in tumor bed, in case of conservative surgery; 2. Standard fractionation: 50 Gy in 25 fractions in breast or chest wall and nodal drainage with sequential tumor bed boost with 10 Gy in 5 fractions in tumor bed in case of conservative surgery. Patients will be followed for 6 months after radiotherapy to evaluate acute toxicity and quality of life.