Skip to content

Ultra Hypo-fractionation In Carcinoma Breast

An Interventional Study To Assess The Dosimetric Feasibility Of A One-week Adjuvant Hypofractionated Radiotherapy Schedule In Patients With Carcinoma Breast - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/076036
Enrollment
35
Registered
2024-10-29
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Health Condition 1: C00-D49- Neoplasms

Interventions

Intervention1: Application of 5 fraction schedule of adjuvant radiotherapy in breast cancer patients post breast conservation surgery or mastectomy and evaluation the dosimetric feasibility of the pla

Sponsors

Dr Ananya Nandi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All the following criteria must be met: 1. Age more than 18years 2. Female or male 3. Pathologically proven invasive carcinoma of breast 4. Mastectomy or breast conservation surgery 5. Axillary staging and or dissection 6. Complete microscopic excision of primary tumour 7. Early or locally advanced breast cancer 8. Written informed consent 9. Able to comply with follow up N.B. concurrent Trastuzumab or/and endocrine therapies are allowed.

Exclusion criteria

Exclusion criteria: The patient is ineligible if any of the following exclusion criteria is met: 1. age more than 65 year with pT1G1or 2, ER positive, Her 2 negative pN0M0 invasive disease. 2. Ipsilateral micro-invasive disease and non-gradable tumour. 3. Past history of malignancy 4. Contralateral and or previous ipsilateral breast cancer, including DCIS, irrespective of date of diagnosis. 5. Previous thoracic radiotherapy 6. Distant metastasis

Design outcomes

Primary

MeasureTime frame
To assess the dosimetric feasibility of hypofractionated radiotherapy to Target volumes and Organs at riskTimepoint: During execution of radiotherapy treatment

Secondary

MeasureTime frame
1. Acute adverse effects at 1 month. 2. Chronic adverse events at 6 months. 3. Ipsilateral locoregional tumor control at 6 months. 4. Quality of life before and after completion of radiotherapy and after 6 months.Timepoint: at 6 months

Countries

India

Contacts

Public ContactDr Ananya Nandi

Assistant Professor

ajay.rt@aiimsmangalagiri.edu.in7989599004

Outcome results

None listed

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