OnCo
ideasIdea

A biomarker-directed trial of vitamin D after surgery for digestive tract cancers

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.

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.

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.
What would test it
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
Who has to act
research
Cost to try
Medium ($1M to $50M)
Years to first evidence
6
Bottlenecks it attacks

Connected

8top

Pages like this

not linked directly; found by shared links

cancers

3
Colorectal cancerGastric & gastro-oesophageal junction cancerOesophageal cancer

technologies

1
Vitamin D and omega-3 supplementation

targets

1
TP53

trials

1
VITAL (VITamin D and OmegA-3 TriaL)

bottlenecks

2
Biomarkers are not validated or standardisedNo incentive to repurpose cheap drugs