A COMPARATIVE STUDY EVALUATING ACUTE TOXICITY AND BREASTCOSMESIS IN EARLY STAGE BREAST CANCER PATIENTS RECEIVINGMODERATE VERSUS EXTREME HYPOFRACTIONATED RADIOTHERAPY
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Recruiting
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- To compare acute toxicity in breast carcinoma patients treated with moderately Hypofractionated radiotherapy versus extreme hypofractionated radiotherapy.
Study Overview
Brief Summary
A COMPARATIVE STUDY EVALUATING ACUTE TOXICITY AND BREAST COSMESIS IN EARLY STAGE BREAST CANCER PATIENTS RECEIVING MODERATE VERSUS EXTREME HYPOFRACTIONATED RADIOTHERAPY- Breast cancer is treated with surgery, chemotherapy, radiotherapy and hormonal agents. The techniques of radiotherapy available are varied and so are the dose schedules, with more than one standard dose schedules. In this study, we are comparing two standard radiation dose schedules. The 1st one treatment completes in 4 weeks and in the 2nd one treatment completes in 2 weeks. Both of them has been found to be similar in efficacy and toxicity in early stage breast cancer patients of western countries. We plan to evaluate the radiation schedules in terms of the acute toxicity and the breast cosmesis in our Indian population. We believe this study would enable us to take a more informed decision on the choice of dose schedule for the patients with early breast cancer in India.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •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).
- •Written informed consent
- •18 to 70 years
- •Female gender
- •ECOG Performance status
- •Non-metastatic disease.
Exclusion Criteria
- •Any histopathology other than invasive carcinoma and DCIS.
- •Synchronous or metachronous malignancy.
- •Pregnant or lactating women.
- •Uncontrolled concurrent illness like DM, HTN, tuberculosis.
- •Evidence of distant metastasis.
- •Recurrent or residual disease.
- •Previous history of radiation to thoracic and neck area.
- •Patients not meeting dose volume constraints.
Outcomes
Primary Outcomes
To compare acute toxicity in breast carcinoma patients treated with moderately Hypofractionated radiotherapy versus extreme hypofractionated radiotherapy.
Time Frame: Weekly assessment of acute toxicity during radiotherapy at 4 weeks & 3 months
Secondary Outcomes
- -To compare breast cosmesis in breast carcinoma patients treated with moderately hypofractionated radiotherapy versus extreme hypofractionated radiotherapy.(-Skin changes & subcutaneous tissue changes)