Can a short burst of radiation plus triple chemotherapy wipe out rectal cancer before surgery?
NCT ID NCT05253846
First seen Jul 24, 2026 · Last updated Jul 24, 2026
Summary
This phase 2 trial is testing whether a short course of radiation followed by a powerful three-drug chemotherapy regimen (FOLFOXIRI) can completely eliminate tumors in people with locally advanced rectal cancer before they undergo surgery. The study enrolls adults aged 18 to 70 with specific high-risk features. The goal is to see if this total neoadjuvant therapy leads to a pathological complete response, meaning no cancer cells remain in the removed tissue.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- a combination of short-course radiotherapy, FOLFOXIRI chemotherapy (irinotecan, oxaliplatin, leucovorin, 5-fluorouracil), and surgery
- What this could lead to
- If successful, this approach could increase the chance of eliminating all cancer cells before surgery, potentially improving long-term outcomes and reducing the need for additional treatments.
- What could go wrong
- This is a phase 2 trial with a small number of participants, so results may not apply to all patients. The intensive chemotherapy regimen carries risks of significant side effects, including toxicity.
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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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U.O. Oncologia Medica 2 Universitaria - Azienda Ospedaliero-Universitaria Pisana Dipartimento di Ricerca Traslazionale e Nuove Tecnologie - University of Pisa
Pisa, 56126, Italy
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Other studies related to the condition(s) this trial covers.
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- New combo without chemotherapy aims to shrink rectal tumors before surgery
- Could chemo replace surgery for rectal cancer? new study explores
- Oxygen-Boosting injection may help rectal cancer patients avoid surgery