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OncoMatch/Clinical Trials/NCT04389086

Induction Chemotherapy for Locally Recurrent Rectal Cancer

Official title: Multicentre, Open-label, Randomised, Controlled, Parallel Arms Clinical Trial of Induction Chemotherapy Followed by Chemoradiotherapy Versus Chemoradiotherapy Alone as Neoadjuvant Treatment for Locally Recurrent Rectal Cancer - PelvEx II

Is NCT04389086 recruiting? Yes, currently enrolling (Oct 2026). This Phase 3 trial studies Combination drug for recurrent rectal cancer.

Phase 3RecruitingCatharina Ziekenhuis EindhovenNCT04389086Data as of Oct 2026Location: International · 5 countries

Treatment: Combination drug — This is a multicentre, open-label, parallel arms, phase IIII study that randomises patients with locally recurrent rectal cancer in a 1:1 ratio to receive either induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery (experimental arm) or neoadjuvant chemoradiotherapy and surgery alone (control arm)

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Extracted eligibility criteria

Treatments studied

Other

Combination drug

Cancer type

Colorectal Cancer

Biomarker criteria

Excluded: DPYD homozygous deficiency

Known homozygous DPD deficiency

Performance status

WHO 0–1

Prior therapy

Cannot have received: chemotherapy

Cannot have received: radiotherapy

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT04389086 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior chemotherapy, radiotherapy disqualifies patients from enrollment.

Are patients with DPYD alterations eligible?

No. DPYD homozygous deficiency is an exclusion criterion.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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