MICC Research Newsletter 2020 Vol 2 Iss 1 (1)

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Page 5MICC NewsletterQ- Since CReDO was started, has it made an impact in India?A– A total of 5 CReDO workshops have been conducted until now and around 250 people have beentrained. We send follow-up questionnaires to participants after the course to enquire about their progressand to motivate them to carry out their projects.The biggest challenge is that participants go back fully charged with their protocols but many of them donot get adequate support and funding after the workshop. We are trying to address these problems in twoways.First, some of the protocols developed at CReDO are considered for funding by the National Cancer Grid ofIndia (NCG). Second, we have the NCG Contract Research Organisation (CRO) to help with trial logistics. Inaddition, we are working on setting up an academic Clinical Trials Unit (CTU) to help with study design andplanning. Several studies developed at the previous CReDO workshops are now full-fledged multi-centrictrials with NCG funding and support.Q- What are the fees for the workshop? Can an applicant apply for any scholarship orsubsidy?A- The course fee at present for academic participants from LMICs is Rs. 10,000, which includes transportto/from Mumbai to Lonavala, accommodation and food for participants during the workshop, and access tocourse material. This is a heavily subsidised fee, since the actual cost per participant is almost twenty timeshigher. CReDO is a non-profit venture; we want to encourage participants from all regions and do not wantthe fee to be a limiting factor. This has been possible by support from several organisations which fund usdirectly or indirectly namely, the Tata Trust, Tata Memorial Centre, National Cancer Institute, USA, King’sCollege London, American Society of Clinical Oncology and the Indian Council of Medical Research.
Page 6MICC NewsletterShowcasing Research in Breast DMGClinical Trial 1:Title: A phase III, multicentre, randomised, double-blind, placebo-controlled study of XXX (Anti-PD-L1Antibody) in combination with paclitaxel compared with placebo with Paclitaxel for patients withpreviously untreated inoperable locally advanced or metastatic triple negative breast cancer.Centres and Local PI: Max Patparganj and Dr Meenu WaliaStudy Objectives: Evaluation of the efficacy, safety, and pharmacokinetics (Pk) of atezolizumab pluspaclitaxel compared with placebo plus paclitaxel in patients with inoperable locally advanced or metastaticTriple-negative adenocarcinoma of the breast (TNBC) who have not received prior systemic therapy forthese conditions.PrimaryObjectiveSecondaryObjectivesExploratoryObjectivesBiomarker• Progression Free Survival(PFS)• Overall Survival (OS)• 12-month and 18-monthOS rates• Health-related Quality ofLife (HRQoL)• 12-month PFS rate• Objective Response Rate(ORR)• Duration of objectiveResponse (DoR)• Clinical Benefit Rate (CBR)• Safety• Pk• Immunogenicity• Second line PFS (PFS2)• EORTC QLQ-C30 andQLQ-BR23• Global HealthStatus/HRQoL scale• European Quality of Life 5Dimension (EQ-5D)• Functional Assessment ofCancer Therapy – General(FACT-G)• Potential effects ofAnti-therapeuticAntibodies (ATAs)• Activity and safety ofXXX according toProgrammed Death−ligand 1 (PD-L1)statusStudy Design:Multicentre double-blind randomised phase III trialPaclitaxel 90 mg/m 2 d1, 8,15 + placebo d1 & 15Metastatic or unresectablelocally advanced TNBCN=495R1:2Cycles repeated q28dPaclitaxel 90 mg/m 2 d1, 8,15 + atezo 840 mg d1 & 15Treat to PD,unacceptable toxicity orwithdrawal of consent
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MICC Research Newsletter 2020 Vol 2 Iss 1 (1)

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