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Boosting radiation may help more rectal cancer patients reach remission

NCT ID NCT07200141

Disease control Sponsor: Peking Union Medical College Hospital 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a higher dose of radiation (58.75 Gy) given before surgery can help more people with locally advanced rectal cancer achieve a complete response (no cancer left) compared to the standard dose (50 Gy). About 156 adults aged 18-79 will receive radiation plus chemotherapy, then either surgery or a watch-and-wait approach. The goal is to improve tumor control and possibly avoid surgery.

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

About 156 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 80 years

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: 1. Age ≥18 and \<80 years 2. Histologically confirmed rectal adenocarcinoma 3. Tumor located within 10 cm from the anal verge 4. MRI staging: T3-T4 and/or N+, M0 (AJCC 8th edition) 5. ECOG performance status 0-2 6. Adequate bone marrow function: WBC ≥3×10⁹/L, ANC ≥1.5×10⁹/L, PLT ≥100×10⁹/L, Hb ≥90 g/L 7. Adequate liver function: TBIL ≤1.5 × ULN, ALT/AST ≤2.5 × ULN 8. Adequate renal function: Cr ≤1.5 × ULN or CCr ≥60 mL/min 9. Signed informed consent Exclusion Criteria: 1. Prior rectal cancer surgery 2. Prior induction chemotherapy, immunotherapy, or pelvic radiotherapy 3. History of other malignancies 4. History of chronic colitis, ulcerative colitis, or nonspecific proctitis 5. Pregnant or breastfeeding women 6. Active infection or fever 7. Severe uncontrolled comorbidities (e.g., unstable heart disease, renal disease, chronic hepatitis, uncontrolled diabetes, psychiatric disorders) 8. Inability to comply with study protocol

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Conditions

The condition(s) this trial relates to.

rectum adenocarcinoma

As listed by the trial registrant

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

Locally advanced rectal adenocarcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.