Hypofractionated Radiation Therapy in Patients With Breast Cancer (HRBC)
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|ClinicalTrials.gov Identifier: NCT04075058|
Recruitment Status : Enrolling by invitation
First Posted : August 30, 2019
Last Update Posted : September 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Radiation: Hypofractionated Radiation therapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Randomized Study Comparing Two Adjuvant Hypofractionated Radiation Schedules in Patients With Breast Cancer|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||March 2022|
Patients with breast cancer post mastectomy or after breast conservative surgery to be treated with a hypofractionated radiotherapy dose of 34Gy in 10 fractions over 2 weeks.
Radiation: Hypofractionated Radiation therapy
Active Comparator: Control
Patients with breast cancer post mastectomy or after breast conservative surgery to be treated with a hypofractionated radiotherapy dose of 35Gy in 15 fractions over 3 weeks
Radiation: Hypofractionated Radiation therapy
- Local Recurrence [ Time Frame: 5 years ]Any recurrence with in the irradiated area from completion of radiation
- Acute skin toxicity [ Time Frame: After 1 month of completion of radiation ]Acute toxicity will be assessed using a RTOG grading system. Assessment will be carried out weekly during radiotherapy and for 4 weeks after treatment.
- Cosmetic assessment [ Time Frame: Baseline, 1 year, 3 years, 5 years ]done using Harvard/National Surgical Adjuvant Bowel and Breast Project(NSABP)/Radiation Therapy Oncology Group(RTOG) breast cosmesis grading scale. Grading will be done as Excellent- no or minimal difference between two breasts,Good- slight difference between two breasts,Good- slight and Fair minimal difference between two breasts, Fair- obvious difference between two breasts Poor- marked difference between two breasts. Excellent/good and fair/poor will be considered better and worse outcomes, respectively.
- Quality of life [ Time Frame: 3 year, 5 year ]EORTC QLQ -30 The QLQ-C30 is composed of both multi-item scales and single-item measures, as well as five functional scales, three symptom scales, a global health status/QoL scale, and six single items.The scores must be averaged and linearly transformed to obtain a range of scores from 0 to 100, with a higher score representing a greater response level. Thus, a high score for a functional scale represents a healthy level of functioning and a high score for the global health status represents a high QoL, but a high score for the symptom scale represents a high level of symptomatology.
- Quality of life [ Time Frame: 3 year, 5 year ]EORTC QLQ-BR 23 It contains 23 items rated on a four-point scale ranging from 1 (not at all) to 4 (very much). The items assess the side effects of therapy, arm symptoms, breast symptoms, body image, and sexual function. Additionally, there are single items assessing sexual enjoyment, anxiety caused by hair loss, and future outlook. The scores range between 0-100 points. For scales evaluating function, a higher score represents a higher level of functioning. For scales evaluating symptoms, a higher score indicates more severe symptoms.
- Disease free survival [ Time Frame: 5 years, 10 years ]Time interval free from locoregional recurrence and metastasis
- Overall survival [ Time Frame: 5 years, 10 years ]From the date of diagnosis to death
- Arm edema [ Time Frame: 3 years, 5 years, 10 years ]Will be graded by measuring arm circumference 10cm above and below the medial epicondyle of humerus. Treated side will be compared with the untreated opposite side as a reference. It will be classified as none, mild, moderate and marked if there was no difference, 0.5-2cm, 2.1-3cm and >3cm difference, respectively in the circumference of the affected and normal arm.
- Late effects- pain, shoulder stiffness [ Time Frame: 3 years, 5 years, 10 years ]A four point scale(none, a little, quite a bit, very much ) will be used to asess all late effects according to the RTOG LENT SOMA scale(Cox et al, 1995).
- Late effects- Brachial plexopathy [ Time Frame: 3 years, 5 years, 10 years ]If the patient had symptoms of pain in the arm, paresthesia, numbness, weakness, or other sensory symptoms then injury to the brachial plexus will be suspected and reported as brachial plexopathy.
- Late effects- Lung, cardiac [ Time Frame: 5 years, 10 years ]Late lung and cardiac toxicity asess all late effects according to the RTOG LENT SOMA scale (Cox et al, 1995).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075058
|Dr Budhi Singh Yadav|
|Chandigarh, N/A = Not Applicable, India, 91 160012|
|Principal Investigator:||Budhi S Yadav, MD||PGIMER, Chandigarh, India|