Could skipping chemo be safer for early rectal cancer?

NCT ID NCT07669298

Recruiting now Disease control Sponsor: Medical University of Gdansk Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This trial tests whether close follow-up (active surveillance) is as good as chemoradiotherapy for preventing cancer return after early-stage rectal cancer removal. About 480 adults with intermediate-risk T1 rectal cancer will be randomly assigned to either regular checkups and scans for 5 years or a 5-week course of radiation plus chemotherapy. The goal is to see if surveillance causes fewer serious side effects while keeping cancer outcomes similar.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Active surveillance (regular checkups and scans) vs chemoradiotherapy (radiation plus capecitabine or 5-FU chemotherapy)
What this could lead to: If active surveillance works as well as chemoradiotherapy, patients with early rectal cancer could avoid harsh treatments and their side effects, while still staying safe from cancer recurrence.
What could go wrong: This is a mid-stage trial with 480 participants, so results may not apply to everyone. Active surveillance might miss cancer regrowth, and chemoradiotherapy has known risks like bowel problems or severe side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

rectal cancer rectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

RECTAL CANCER

Contacts and locations

Locations

Institute of Oncology in Warsaw
RECRUITING

Warsaw, Poland
University Clinical Centre
RECRUITING

Gdansk, 80210, Poland
University Hospital, Limoges
NOT_YET_RECRUITING

Limoges, France

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