A STUDY COMPARING ACUTE SIDE EFFECTS AND BREAST COSMESIS IN EARLY STAGE BREAST CANCER PATIENTS RECEIVING SHORT COURSE RADIOTHERAPY VERSUS VERY SHORT COURSE RADIOTHERAPY

A COMPARATIVE STUDY EVALUATING ACUTE TOXICITY AND BREAST COSMESIS IN EARLY STAGE BREAST CANCER PATIENTS RECEIVING MODERATE VERSUS EXTREME HYPOFRACTIONATED RADIOTHERAPY

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/06/053665

Enrollment

Registered

2023-06-08

Start date

Unknown

Completion date

Unknown

Last updated

2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: EXTREME HYPOFRACTIONATED RT IN EARLY STAGE BREAST CANCER PATIENTS: ARM B OF THE STTUDY WILL INCLUDE POST OP EARLY BREAST CANCER PATIENT WHO WILL RECEIVE 26Gy/5#daily +boost of 12.5/5# d

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histologically proven invasive carcinoma of the breast cT1-T2 N0-1M0 and cT3N0 AJCC stage 1 & 2 patients following complete excision of the primary tumour by breast conservation surgery. There should be adequate surgical resection of primary (ink negative) and nodal disease (negative sentinel lymph node biopsy or adequate axillary sampling or dissection (yield atleast 10 nodes). 2. Written informed consent 3. Age - 18 to 70 years 4. Female gender 5. ECOG Performance status 0 - 2 6. Non-metastatic disease.

Exclusion criteria

Exclusion criteria: 1. Any histopathology other than invasive carcinoma and DCIS. 2. Synchronous or metachronous malignancy. 3. Pregnant or lactating women. 4. Uncontrolled concurrent illness like DM, HTN, tuberculosis. 5. Evidence of distant metastasis. 6. Recurrent or residual disease. 7. Previous history of radiation to thoracic and neck area. 8. Patients not meeting dose volume constraints.

Design outcomes

Primary

Measure	Time frame
To compare acute toxicity in breast carcinoma patients treated with moderately Hypofractionated radiotherapy versus extreme hypofractionated radiotherapy.Timepoint: Weekly assessment of acute toxicity during radiotherapy at 4 weeks & 3 months	—

Secondary

Measure	Time frame
-To compare breast cosmesis in breast carcinoma patients treated with moderately hypofractionated radiotherapy versus extreme hypofractionated radiotherapy. -Skin changes & subcutaneous tissue changesTimepoint: Cosmetic evaluation- baseline, end of RT, 6 months post RT & 1 year post RT.	—

Countries

India

Contacts

Public ContactPRASHANTH GIRIDHAR

MAHAMANA PANDIT MADAN MOHAN MALVIYA CANCER CENTRE (MPMMCC)

lincoln.pujari@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026