{"entity":{"id":"idea-reg-vitamin-d-digestive-cancer-biomarker-trial","kind":"idea","name":"A biomarker-directed trial of vitamin D after surgery for digestive tract cancers","aka":[],"tldr":"A Japanese trial found vitamin D supplements did not help everyone after digestive cancer surgery, but appeared to help a subgroup identified by a tumour marker. That subgroup deserves its own trial.","summary":"The AMATERASU trial of vitamin D3 after surgery for digestive tract cancers was negative overall, but pre-specified and post-hoc analyses reported large relapse and death reductions in subgroups (p53-immunoreactive tumours, low-to-mid baseline vitamin D). Similar biomarker-restricted signals appeared in SUNSHINE (colorectal, high-dose vitamin D with chemotherapy). Vitamin D is nearly free. The proposal is a confirmatory randomised trial restricted to the biomarker-defined subgroup, with relapse-free survival as the primary endpoint, funded publicly.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (No incentive to repurpose cheap drugs): Pantziarka et al., The Repurposing Drugs in Oncology (ReDO) Project (ecancer 2014)","url":"https://doi.org/10.3332/ecancer.2014.442"}],"tags":[],"related":[],"cancers":["colorectal","gastric","esophageal"],"sections":[],"technologies":[],"targets":["tp53"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-generic-repurposing","b-biomarker-validation"],"keyPapers":["paper-pantziarka-ecancermedicalscience"],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Vitamin D3 2,000 IU daily improves 5-year relapse-free survival by at least 10 absolute percentage points in patients with p53-immunoreactive digestive tract cancers after curative surgery.","rationale":"Subgroup findings from a negative trial are usually false, but this one was pre-specified in part, is mechanistically plausible and is being echoed in a second trial; the cost of a definitive test is trivial relative to the potential benefit in common cancers.","test":"Randomised placebo-controlled trial of about 800 biomarker-positive patients across Japan and Europe with RFS primary endpoint and serum vitamin D monitoring.","maturity":"early-clinical","actor":"research","cost":"medium","horizonYears":6},"route":"/ideas/idea-reg-vitamin-d-digestive-cancer-biomarker-trial/","neighbours":{"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"gastric","kind":"cancer","name":"Gastric & gastro-oesophageal junction cancer","route":"/cancers/gastric/"},{"id":"esophageal","kind":"cancer","name":"Oesophageal cancer","route":"/cancers/esophageal/"}],"target":[{"id":"tp53","kind":"target","name":"TP53","route":"/targets/tp53/"}],"bottleneck":[{"id":"b-biomarker-validation","kind":"bottleneck","name":"Biomarkers are not validated or standardised","route":"/bottlenecks/b-biomarker-validation/"},{"id":"b-generic-repurposing","kind":"bottleneck","name":"No incentive to repurpose cheap drugs","route":"/bottlenecks/b-generic-repurposing/"}],"paper":[{"id":"paper-pantziarka-ecancermedicalscience","kind":"paper","name":"The Repurposing Drugs in Oncology (ReDO) Project","route":"/key-papers/paper-pantziarka-ecancermedicalscience/"}],"technology":[{"id":"vitamin-d-omega3-supplementation","kind":"technology","name":"Vitamin D and omega-3 supplementation","route":"/technologies/vitamin-d-omega3-supplementation/"}],"trial":[{"id":"vital","kind":"trial","name":"VITAL (VITamin D and OmegA-3 TriaL)","route":"/trials/vital/"}]}}