Evaluation of Two Boost Radiation Schedules in Post Lumpectomy Early Stage Carcinoma Breast

NCT02142907 | Completed DMC

• 1 other identifier: BD
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer; Adverse Effect of Radiation Therapy

Keywords

Breast conservative surgery; boost radiation; acute toxicity; cosmesis; local control

Outcome Measures

Primary Outcomes (1)

• Radiation toxicities- acute and early-late

  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

  6 months

Secondary Outcomes (1)

• Cosmetic outcome and local control iii) Local control

  6 months to 5 years

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stage I , stage II of breast carcinoma with breast conservative surgery

You may qualify if:

• Unicentric primary breast cancer with invasive ductal histology.
• Stage T1, T2, N0, N1, M0 -

You may not qualify if:

• Tumor histology with invasive or in situ lobular carcinoma or pure ductal carcinoma in situ.
• Skin involvement.
• History of prior primary malignancy.
• History of prior irradiation to chest
• Patients who received neoadjuvant chemotherapy. -

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Dr Budhi Singh Yadav

Chandigarh, N/A = Not Applicable, 91 160012, India

Location

MeSH Terms

Conditions

Breast Neoplasms; Radiation Injuries

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Wounds and Injuries

Study Officials

• Budhi S Yadav, MD

  Post Graduate Institute of Medical Education & Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: May 20, 2014
• Study Start: January 1, 2013
• Primary Completion: January 1, 2020
• Study Completion: December 1, 2020
• Last Updated: June 23, 2021

Record last verified: 2021-06

Locations

IN (1)