Fractionation trial of adjuvant radiation following immediate autologous breast reconstruction
- Conditions
- 1.Histologically confirmed preinvasive or invasive, Stage I – III breast cancer at initial presentation 2. Considered for whole breast reconstruction3. Merits adjuvant RT
- Registration Number
- CTRI/2017/01/007745
- Lead Sponsor
- Dr Prof Rajendra Badwe
- Brief Summary
Patients undergoing a partial or total mastectomy and IBR and eligible for post-operative RT (as decided in the joint clinic) will be screened for the trial. Patients will be randomized to conventional (Arm A 50 Gy in 25 fractions) or hypo-fractionation (Arm B 40 Gy in 15 fractions) arms. Randomization will be done by permuted blocks with the block length being varied randomly to minimise the effect of entry bias. All patients will receive 3-5 weeks of adjuvant RT as per the treatment arm allocated. It will be desirable to start adjuvant RT with 4-6 weeks of either the date of surgery or date of last chemotherapy whichever is relevant.
**Pre and post treatment evaluation:**
***1 Quality of Life (QOL) forms:***
All patients accrued in the trial will fill up the “Reconstruction module†of the BREAST-Q questionnaire which is specific for breast cancer patients undergoing reconstruction using abdominal flap, nipple or implant. The BREAST-Q is owned and copyrighted by Memorial Sloan-Kettering Cancer Center (MSKCC) and the University of British Columbia. The development and psychometric properties of this instrument have been published by the authors from MSKCC followed by subsequent reports of the validation of this instrument other institutes (22, 23, 24). As BREAST-Q was not available in Indian languages, the linguistic validation of the reconstruction module of this instrument was carried out and published by the principal investigator on this project (25,26). Hence this questionnaire will be used in the current project without any additional items or questions.
The satisfaction domains have 4-point Likert like response category options (“Very Dissatisfiedâ€, “Somewhat Dissatisfiedâ€, “Somewhat Satisfied†and “Very Satisfiedâ€); physical and psychosocial domains have 5-point Likert like response category options (“None of the timeâ€, “A Little of the timeâ€, “Some of the timeâ€, Most of the time†and “All of the timeâ€) whereas the agreement domain has either 3 or 4 response category options (“Definitely Disagreeâ€, “Somewhat Disagreeâ€, “Somewhat Agree†and “Definitely Agreeâ€). Two additional items to score arm edema and skin changes on the same 5 point and 4 point response format as BREAST-Q measure respectively will be used (these not being covered in the BREAST-Q). This assessment will be done at baseline (pre-op module prior to surgery and post op module prior to RT starting), and at 6, 12, 24, 42 and 60 months post randomization.
***2 Clinical assessment of breast shrinkage/fibrosis***
All patients will be followed up for routine clinical assessment at 6 monthly intervals for the first 5 years and yearly thereafter. Clinical data on skin fibrosis (centre, pectoral fold and infra-mammary fold), shrinkage, size and shape of the reconstructed breast will be recorded on the pre-printed case report forms and stored securely by the study team. This will be scored each on a 4-point graded scale (none, a little, quite a bit, very much). Other significant history of ischaemic heart disease, rib fracture and symptomatic lung fibrosis will also be recorded.
***3 Morbidity assessment:***
Major complications will be defined as those requiring corrective (revision) surgery (for wound complications or volume loss) or loss of reconstruction. Minor complications include infection, chest wall fibrosis, fat necrosis (FN), or contracture. The incidence and severity of the morbidity at the graft and donor sites will be recorded for each patient.
***4 Radiologic assessment:***
For assessing the periodic shrinkage of the reconstructed breast, volumetric assessment of the normal and reconstructed breast will be done on the institutional Mammography machine at baseline prior to RT and at 1, 2 and 3.5 and 5 years.
***5 Photographic assessment:***
Photographs will be taken at baseline (post-surgery and pre-radiotherapy) and then at 1, 2, 3.5 and 5 years to assess changes to the reconstructed breast based on change in size, shrinkage, and shape, and scored on a 3-point graded scale (none, mild, marked). Changes in breast appearance (photographic) will be scored by three observers (surgical oncologist, plastic surgeon and radiation oncologist) blind to patient identity, treatment allocation, and year of follow-up, and a final agreed score will be reached by consensus. Breast size and surgical deficit will be defined from the baseline photographs by the same three observers applying 3-point graded scales. Patient developing relapse will be withdrawn from the assessment beyond the time of relapse.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Female
- Target Recruitment
- 160
- 1.Known case of pre-invasive or invasive breast carcinoma (any histological subtype) 2.Stage I – III (Operable breast cancer or Locally Advanced breast cancer) at initial presentation 3.Age > 18 years 4.Undergone IBR following total mastectomy.
- 5.Eligible for adjuvant RT as per institutional protocol 6.Willing to give written informed consent.
1.Histological diagnosis of phyllodes or sarcoma of the breast 2.Male breast cancer 3.History of receipt of previous RT to the chest wall 4.Pregnant unless willing to terminate pregnancy prior to initiation of radiotherapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Satisfaction with breast reconstruction and outcome of surgery 1.Satisfaction with breast reconstruction and outcome of surgery | 2.Late normal tissue effects (shrinkage / fibrosis of reconstructed breast) 2.Late normal tissue effects (shrinkage / fibrosis of reconstructed breast) 1.Satisfaction with breast reconstruction and outcome of surgery | 2.Late normal tissue effects (shrinkage / fibrosis of reconstructed breast)
- Secondary Outcome Measures
Name Time Method 1.Health related Quality of life (HRQOL) 2.Complication rates like fat necrosis, infection, re-surgery
Trial Locations
- Locations (1)
TATA MEMORIAL HOSPITAL
🇮🇳(Suburban), MAHARASHTRA, India
TATA MEMORIAL HOSPITAL🇮🇳(Suburban), MAHARASHTRA, IndiaTabassum WadasadawalaPrincipal investigatordrtabs.radonc@gmail.com