InPOG-HL-15-01 - Challenges and lessons learnt in setting up the first collaborative multicentre prospective clinical trial in childhood cancer in India

Abstract

InPOG-HL-15-01 is a multicenter Indian Pediatric Oncology Group (InPOG) study for childhood Hodgkin lymphoma in India. The aim is to describe the epidemiology and outcomes of these children on a risk-stratified, response-based strategy on an ABVD backbone with radiation reserved for those with bulky disease or suboptimal response. In this manuscript we share the challenges and lessons learnt in setting up and conducting this study successfully. The protocol was peer-reviewed, ethical approval was obtained and it was registered on the Clinical Trial Registry of India. Funding was limited and a national non-governmental organisation was the sponsor. Data collection was done on Google Forms. At end of recruitment, 410 patients were enrolled from 27 centres from 2015 to 2018. Follow-up and follow-on studies are in process. This study will provide valuable information on childhood HL in India as well as conduct of similar future InPOG studies.

Keywords

• Hodgkin lymphoma
• Child
• India
• Clinical trials
• Multicentre studies