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New radiation boost may improve rectal cancer treatment

NCT ID NCT06246344

Disease control Sponsor: Shandong Cancer Hospital and Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Updated 2 times

Summary

This study tests whether giving a higher, targeted radiation dose to the main tumor and nearby lymph nodes can improve outcomes for people with locally advanced rectal cancer. About 128 adults whose cancer has not spread beyond the pelvis will receive either standard radiation or an adaptive boost that adjusts the dose based on imaging. The goal is to see if this approach leads to more complete tumor disappearance before surgery and makes the operation safer.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 128 people

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

Started

Dec 2023

Expected to finish

Dec 2030

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 75 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 years or older. 2. ECOG performance status of 0 or 1. 3. Histologically confirmed rectal adenocarcinoma. 4. Primary tumor located within 10 cm of the anal verge by pelvic MRI and/or rigid sigmoidoscopy. 5. Clinically involved regional lymph nodes (cN1-2) according to the AJCC 8th edition. 6. At least one additional high-risk feature: cT4 disease, cN2 disease, extramural vascular invasion, mesorectal fascia involvement, lateral pelvic lymph-node involvement, tumor deposits, or low rectal cancer (≤5 cm from the anal verge). 7. Baseline locoregional staging with contrast-enhanced pelvic MRI and chest/abdominal imaging excluding distant metastases. 8. Treatment-naïve with respect to systemic therapy and pelvic radiotherapy for the index rectal cancer and suitable for total mesorectal excision. 9. Adequate organ function and no medical contraindication to chemoradiotherapy. 10. Written informed consent before study-specific procedures. Exclusion Criteria 1. Prior pelvic radiotherapy. 2. Prior rectal surgery for the index cancer, including local excision or transanal procedures. 3. Radiologically or pathologically confirmed distant metastasis. 4. Locally recurrent rectal cancer. 5. Active inflammatory bowel disease. 6. History of another primary malignancy within the preceding 5 years, except adequately treated non-melanoma skin cancer or carcinoma in situ. 7. Pregnancy or lactation. 8. Severe or uncontrolled medical condition contraindicating chemoradiotherapy or surgery. 9. Clinically significant hypersensitivity to protocol systemic therapy that precludes treatment.

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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

  • Department of Radiation Oncology, Shandong Cancer Hospital and Institute

    Jinan, Shandong, 0531, China

More trials for these conditions

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