Studying of two different techniques of radiation therapy in breast cancer patients after tumor excision surgery.

Phase 2

Recruiting

• Conditions: STABLE, FIT FOR TREATMENT

• Registration Number: CTRI/2018/04/013008
• Lead Sponsor: PGIMER

Brief Summary

Breast irradiation has reduced the rate of localrecurrence significantly in case of breast cancer which have undergone breastconservative surgery. The recurrence of cancer is most likely in theregion surrounding the original tumor, therefore addition of boost irradiationto the tumor bed after whole breast irradiation has been shown to furtherimprove local control. Conventionally the radiation treatment is delivered in a sequential manner of whole breast radiation followed by boost dose delivery. While now with the introduction of volumetricarc therapy (VMAT) technique, simultaneous irradiation of tumour bed is alsopossible with the radiation of whole breast. It helps in achieving minimaldoses to the organs at risk. The simultaneous boost technique will be compared with sequential boost where the boost dose will be delivered after the delivery of whole breast radiation. Doses will be studied in both the arms in terms of target coverage, homogenity and doses to organs at risk. The radiation treatment has cosmeticeffects on the treated breast. The study will assess the cosmeticeffects on the treated breast as compared to the untreated breast. Cosmetic effects will be assessed by both subjective and objective methods.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-05
• Last Update Posted: 2018-03-26

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

BREAST CANCER PATIENTS AFTER BREAST CONSERVING SURGERY.

Exclusion Criteria

patients with poor KPS (performance status ) patients with double malignancy patients with history of prior radiation patients >70 years of age.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dosimetry and cosmetic outcomes and acute toxicities	Post radiation, 1 month, 3 months, 6 months

Secondary Outcome Measures

Name	Time	Method
Late toxicities, locoregional control, TOXICITIES, disease free survival, event free survival, overall survival.	immediately post radiation, 1 month post radiation, 3 month post radiation, 6 month post radiation

Trial Locations

Locations (1)

PGIMER; 🇮🇳 Chandigarh, CHANDIGARH, India

PGIMER

🇮🇳Chandigarh, CHANDIGARH, India

Dr Shipra gupta

Principal investigator

8527216552

shiprag184@gmail.com