An interventional study of 3 week RT and 1 week RT in Breast Cancer Female, sponsored by Tata Medical Center. Recruiting at 1 site in India. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-23.
Sponsored by Tata Medical Center · Not applicable, Interventional, and Treatment
Background:Moderate three week hypofractionated adjuvant radiotherapy schedule is a standard care in breast cancers. A five day schedule has been demonstrated to be iso-toxic as a standard three week schedule. Recently studies have also demonstrated the safety and feasibility of simultaneous integrated boost in this setting. This randomized trial will investigate if a one-week course of hypofractionated breast radiotherapy is non-inferior to a three week course.
Aim: To determine if one-week schedule of adjuvant radiotherapy in breast cancer is non-inferior to a three week schedule.
Primary Objective: Locoregional Recurrence Rate (LRR) (Cumulative proportion of patients with locoregional recurrence) at 5 years
Secondary Objective:
Hypothesis:
Design: Open-label, parallel group, two arm, randomised, phase III, non-inferiority trial.
Population: Patients with breast cancer who need adjuvant radiotherapy after breast conservation or mastectomy.
Intervention: Patients will be randomized to 15 days or 5 days of radiotherapy to the whole breast or chest wall or reconstructed breast. Nodal radiation will be delivered as indicated. A simultaneous integrated boost (SIB) will be delivered to patients who need a tumor bed boost after breast cancer. The following dose schedules will be tested:
Control Group: 40 Gy in 15 fractions over 3 weeks (with SIB of 8 Gy)*
Test Group: 26 Gy in 5 fractions over 1 week (with SIB of 6 Gy).*
* Use of Sequential Boost is allowed in both arms if prespecified by the institution. If used dose is 12 Gy in 4 fractions in 1 week in both arms.
Outcomes and measures:
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 2,100 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Tata Medical Center is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients after mastectomy if any of the below:
Exclusion Criteria:
Adjuvant Radiotherapy delivered over 3 weeks
Radiation: 3 week RT
Adjuvant Radiotherapy delivered over 1 week
Radiation: 1 week RT
40 Gy in 15 fractions over 3 weeks to the whole breast or chest wall. Patients undergoing breast conservation therapy will receive additional boost radiotherapy to the tumor bed. The supraclavicular fossa will be treated in patient with node positive disease or those receiving neoadjuvant chemotherapy. IMC and Axillary radiotherapy will be given as per the institutional policy. Boost Dose schedule for BCS patients will be 8 Gy delivered in 15 fractions simultaneously with tangential EBRT. In institutions planning for sequential boost, a dose of 12 Gy in 4 fractions will be delivered after whole breast EBRT.
26 Gy in 5 fractions over 1 week to the whole breast or chest wall. Treatment volumes will be same as the control arm. Additional boost will be delivered to patients who have undergone breast conservation. Boost Dose schedule for BCS patients will be 6 Gy delivered in 5 fractions simultaneously with tangential EBRT. In institutions planning for sequential boost, a dose of 12 Gy in 4 fractions will be delivered after whole breast EBRT.
Locoregional Recurrence Rate (LRR)
Cumulative proportion of patients with locoregional recurrence
Time frame: 5 years
Overall Survival (OS )
Time from randomization to the time of death due to any cause. Cumulative proportion reported at 5 years
Time frame: 5 Years
Invasive Disease Free Survival ( iDFS )
Time from randomization to any disease recurrence, death due to any cause or second primary invasive cancer. Cumulative proportion reported at 5 years.
Time frame: 5 Years
Adverse Event ( AE )
Proportion of patients with late Grade 2 or more AE as defined by the CTCAE 5 criteria
Time frame: 5 Years
Quality of Life ( QoL )
Proportion of patients with a worse summary score in the health related quality of life as measured using the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ C30) at 12 months post-treatment as compared to the baseline score. The total summary score may range between 0 - 100 with higher scores indicating better health related quality of life. This score is the mean of the 13 of the 15 items of the EORTC QLQ C30 questionnaire which include the scores related to all the domains excepting the Global quality of life scale and Financial impact scale.
Time frame: 12 months
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tata Medical Center