# Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy.

Source: https://onco.cc/trials/nct03869892/  
OnCo record `nct03869892` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of capecitabine in colorectal cancer, run by Institut de Recherches Internationales Servier, active but no longer recruiting.

## Summary

Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy. is a phase 3, randomised interventional study registered as NCT03869892 by Institut de Recherches Internationales Servier, with a registry enrolment figure of 856 participants, started 2019-03-21 and due to reach its primary completion in 2021-06-29. Interventions recorded: Trifluridine/tipiracil hydrochloride (S95005); Capecitabine; Bevacizumab experimental; Bevacizumab control. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: Progression-free Survival (PFS). Colorectal eligibility wording from the registry: "Has definitive histologically confirmed adenocarcinoma of the colon or rectum (all other histological types are excluded)". Sites: Argentina, Australia, Austria, Brazil, Bulgaria, Czechia, Denmark, Estonia, France, Germany, Hungary, Ireland and 13 more countries. United Kingdom sites listed: 11. No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-24
- Also known as: SOLSTICE
- Tags: ctgov-ingest; colorectal-deep-dive
- Registry id: NCT03869892
- Phase: 3
- Setting: An Open-label, Randomised, Phase III Study cOmparing trifLuridine/Tipiracil (S 95005) in Combination With Bevacizumab to Capecitabine in Combination With Bevacizumab in firST-line Treatment of Patients With metastatIC Colorectal Cancer Who Are Not candidatE for Intensive Therapy (SOLSTICE Study)
- Sponsor: Institut de Recherches Internationales Servier
- Enrolled: 856

## Notes

- UK sites (registry): Aberdeen Royal Infirmary Oncology Department (Aberdeen); University Hospitals Bristol Bristol Haematology & Oncology Centre (Bristol); St James's University Hospital (Leeds); Leicester Royal Infirmary The HOPE Clinical Trials Unit (Leicester); Royal Marsden Hospital Department of Medicine (London); Hammersmith Hospital Gary Weston Centre (London); Sarah Cannon Research Institute UK Clinical Trials (London); Imperial Healthcare NHS Trust Charing Cross Hospital (London); Christie Hospital NHS Foundation Trust GI & Endocrine (Manchester); Glan Clwyd Hospital North Wales Cancer Treatment Centre (Rhyl); Royal Marsden Hospital Department of Medicine (Sutton).

## Sources

- ClinicalTrials.gov NCT03869892: https://clinicaltrials.gov/study/NCT03869892

## Connected records

- cancers: [Colon cancer (adenocarcinoma of the colon)](https://onco.cc/cancers/colon-cancer/), [Rectal cancer](https://onco.cc/cancers/rectal-cancer/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/)
- drugs: [Capecitabine](https://onco.cc/drugs/capecitabine/)
- terms: [Colorectal cancer trials open today (registry snapshot)](https://onco.cc/terms/colorectal-trials-open-today/)

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JSON: https://onco.cc/api/v1/entities/nct03869892.json