Clinical trial · Observational
Evaluation of Two Boost Radiation Schedules in Post Lumpectomy Early Stage Carcinoma Breast
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In a general radiation oncology practice, breast cancer typically comprises approximately 25% of the total patient caseload.1 Surgery is the primary modality of treatment. Radical mastectomy remained the mainstay of surgical therapy into the 1970s. Breast-conserving surgery followed by radiation therapy to the intact breast is an established standard of care for the majority of women with early stage invasive breast cancer. Recommended techniques for breast-conservation treatment are local excision of the primary tumor, preferably with clear margins, axillary lymph node dissection, and breast irradiation (45 to 50 Gy), usually with a boost (10 to 20 Gy, depending on tumor size and status of the surgical margins). The aim of this study is to compare the two boost regimen 10Gy/5#/1 week with 16Gy/8#/1.5 weeks in post lumpectomy patients of early stage breast cancer, following whole breast irradiation (WBI). The study will include 50 patients, (25 in each arm) of early stage post lumpectomy breast cancer patients. Each patient will be treated by WBI followed by tumor bed boost with either electron beam therapy or 3D CRT. The primary end point of the study will be assessment of acute and late radiation toxicities, cosmetic score analysis and local control between two schedules. Secondary end points will be recurrence-free survival.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adverse Effect of Radiation Therapy | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Radiation toxicities- acute and early-late
- timeFrame
- 6 months
- description
- Acute toxicity will be assessed at at 1 month. Assessment of toxicity will be done as per RTOG scores AND LENT SOMA scale Pigmentary change scale: 0 = None 1. = Transitory , slight 2. = Permanent , marked Breast edema: 0 = None 1 = Asymptomatic 2 = Symptomatic 3 = Secondary dysfunction
Secondary outcomes (1)
- measure
- Cosmetic outcome and local control iii) Local control
- timeFrame
- 6 months to 5 years
- description
- Cosmetic assessment will be done using Harvard/NSABP/RTOG breast cosmesis grading scale.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Unicentric primary breast cancer with invasive ductal histology. 2. Stage T1, T2, N0, N1, M0 - Exclusion Criteria: 1. Tumor histology with invasive or in situ lobular carcinoma or pure ductal carcinoma in situ. 2. Skin involvement. 3. History of prior primary malignancy. 4. History of prior irradiation to chest 5. Patients who received neoadjuvant chemotherapy. -
References
Publications (0)
Data not yet available