Hyport adjuvant schema (2)

Sanjoy Chatterjee

and 2 more

BackgroundHypofractionated radiotherapy is the current standard for adjuvant radiotherapy across many centres. Further hypofractionation may be possible but remains to be investigated in non-caucasian populations with more advanced disease, with a higher proportion of patients requiring mastectomy as well as tumour bed boost. We are reporting the design of randomized controlled trial testing the hypothesis that a one week (5 fractions) regimen of radiotherapy will be non-inferior to a standard three week (15 fractions) schedule. MethodsWe describe a multicenter, randomized controlled trial recruiting patients at large academic centres across India. Patients without distant metastases who merit adjuvant radiotherapy will be eligible for inclusion in the study. Patients in the control arm will receive adjuvant radiotherapy to the breast or chest wall (with/without regional nodes) to a dose of 40 Gy / 15 fractions / 3 weeks, while those in the experimental arm will receive a dose of 26 Gy / 5 fractions / 1 week (to the same volume). Use of a simultaneous integrated boost (dose of 8 Gy and 6 Gy respectively) is allowed in patients who have undergone breast conservation. A sample size of 2100 patients provides an 80% power to detect a non-inferiority of 3% in the 5-year locoregional recurrence rate with a one-sided type I error of 2.5%, assuming that the locoregional recurrence rate in the control arm is 5% at 5 years (corresponding to a hazard ratio of 1.63). Patients will be recruited over a period of 5 years, and followed up for a further 5 years thereafter. Discussion If a five-fraction regimen of breast cancer is proven to be non-inferior, this will result in a  significant improvement in the access to radiotherapy, as well as reduced costs of treatment. The trial gives an opportunity to standardize and quality assure radiotherapy practices across the nation at the same time. Along with the results of the FAST Forward trial, the safety of this intervention in advanced node-positive disease requiring regional nodal radiation will be established.Trial Registration The trial has been registered at the Clinical Trial Registry of India (CTRI) vide registration number: CTRI/2018/12/016816 as well as the clinical trial.gov website at NCT03788213. The HYPORT Adjuvant Trial group is presented in the section \ref{author-details}.
Tmc prom architecture

santam chakraborty

and 5 more

BackgroundElectronic collection of patient-reported outcomes (e-PROM) allows accurate recording of data. They also enable the visualization of longitudinal trends in domain-specific scores for a patient, and may improve patient-physician communication. Several commercial offerings are available but deploying them in countries like India is challenging due to language barriers and literacy levels. Additionally, costs involved remain a major problem. We propose to develop an open-source tool to serve the same purpose.Material and MethodsAfter an exhaustive requirement analysis for a minimum viable product, we decided to proceed with developing the system using an open-source content management system. Additional contributed modules like Webform and Media were used to provide additional functionality. Three tiers of user roles with role-specific privileges were defined. A preliminary user experience testing was done for the patient role.ResultsAll requirements identified in the requirement analysis section have been met. The system allows users with a patient role to fill in questionnaires presented to them. To ensure that diverse groups of patients can be accommodated, patients are grouped according to disease groups. Health care workers can visualize the results of the questionnaire as well as develop new questionnaires using a graphical interface. Initial user experience testing shows that 93.5% of the users (playing the role of patients) were able to use the website without additional help. ConclusionAn open-source system to collect electronic PROM has been developed with localization in Indian languages. We aim to continue developing, validating and extending the system in the future.