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Rectal cancer patients may avoid surgery with new Chemo-Radiation combo

NCT ID NCT04864067

Disease control Sponsor: Servicio de Salud Metropolitano Sur Oriente Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Summary

This study tested a treatment plan for locally advanced rectal cancer that uses a short course of radiation followed by chemotherapy, aiming to avoid surgery. 39 patients were enrolled. The goal was to see if the cancer could be completely controlled without an operation, using a 'watch and wait' approach for those who responded well. The study measured how many patients had a complete response lasting more than a year.

What this could mean

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

Active substance
Oxaliplatin, 5-Fluoracil, Leucovorin, Capecitabine (chemotherapy drugs) and radiation therapy
What this could lead to
If successful, this approach could allow some patients with locally advanced rectal cancer to avoid major surgery and its side effects, while still controlling the disease.
What could go wrong
This is a small, single-arm Phase 2 trial with only 39 participants, so results may not apply to everyone. The long-term safety and effectiveness compared to standard treatment are not yet proven.

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

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

39 people

The number who actually took part.

Started

Jun 2021

Finished

May 2026

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically confirmed diagnosis of adenocarcinoma of the rectum * Clinical Stage II (T3-4, N-) or Stage III (any T, N+) based on Magnetic Resonance Imaging (MRI) * Tumors \< 7cm from anal verge (palpable) * No prior history of rectal cancer Exclusion Criteria * Patients with tumors \>7cm from anal verge * ECOG \>1, * Contraindication for chemotherapy: Hemoglobin \<8, White Blood Count \<4000, Platelets \<100,000, Creatinine Clearance \<50ml/min, Total Bilirubin \<5mg/dl, * Stage IV at diagnosis * Coronary artery disease, either no treated or recent acute coronary syndrome in the last 12 months. * Congestive heart failure * Peripheral neuropathy * Previous pelvic radiotherapy * Prior rectal cancer treatment * Pregnancy or nursery * Any contraindications to MRI (e.g. patients with pacemakers) * Indication of pelvic exenteration * Impossibility to consent.

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Conditions

The condition(s) this trial relates to.

adenocarcinoma 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

  • Complejo Asistencial Doctor Sótero del Rio

    Santiago, RM, Chile

  • Hospital La Florida

    Santiago, RM, Chile

  • Hospital Padre Hurtado

    Santiago, RM, Chile

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