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Second radiation blast for belly tumors: safe or too risky?

NCT ID NCT06397573

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests whether giving another round of high-dose radiation to people with abdominal or pelvic cancers that were previously treated with radiation is safe. Ten participants will receive 5 sessions of focused radiation. The main goal is to see what side effects occur, especially serious ones. This is an early safety trial, not a test of whether the treatment works.

What this could mean

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

Active substance
radiation therapy (reirradiation)
What this could lead to
If successful, this could show that a second round of high-dose radiation is safe and may help control tumors in the abdomen or pelvis that have come back after prior radiation.
What could go wrong
This is a very early, small trial (10 people) focused only on safety, not effectiveness. There is a risk of serious side effects from giving more radiation to an area already treated.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 10 people

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

Started

Jun 2024

Expected to finish

Jun 2027

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 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: * A primary or metastatic lesion in the abdomen or pelvis for which reirradiation will be delivered. There is no maximum lesion size. * Single course of prior radiation therapy with prescribed equivalent dose in 2 Gy fractions (EDQ210) of at least 40 Gy. * 50% isodose line of the prior radiation therapy course is expected to overlap at minimum the 50% isodose line of the radiation therapy delivered in this study. * At least 6 months from completion of prior radiation therapy to initiation of study therapy. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Life expectancy at least 6 months. * Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Abstinence is acceptable if it is the participant's preferred method. Should a participant become pregnant or suspect pregnancy while participating in this study, the treating physician must be informed immediately. * Concurrent hormonal therapy or immunotherapy such as immune checkpoint inhibitor is allowed Exclusion Criteria: * Contraindication to having an MRI scan. * Lesion that would receive study therapy arises from or invades a gastrointestinal (GI) luminal organ (a lesion abutting but not invading a GI luminal organ is permitted) * Lesion that would receive study therapy is not located in the abdomen or pelvis. * \> 1 course of overlapping radiation therapy delivered to the abdomen or pelvis. * \< 70% of the gross tumor volume (GTV) receives at least the 95% of the prescribed dose on the original plan using the simulation day anatomy. * More than 1 lesion in the abdomen or pelvis that requires reirradiation. * History of inflammatory bowel disease. * Unable to acquire DICOM radiation therapy treatment plan from the prior radiation therapy. * Unresolved grade 2+ toxicity (Common Terminology Criteria for Adverse Events version 5.0) from previous anti-cancer therapy. * Any condition in the opinion of the investigator that would interfere with evaluation of study treatment or interpretation of participant safety or study results. * Individuals who are pregnant. * Chemotherapy given within 1 week prior to or following reirradiation. * Vascular endothelial growth factor (VEGF) inhibitor given within 8 weeks prior to or following reirradiation

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Conditions

The condition(s) this trial relates to.

digestive system cancer Pelvic Neoplasms

As listed by the trial registrant

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

Contacts and locations

Locations

  • Miami Cancer Institute at Baptist Health South Florida

    Miami, Florida, 33176, United States

More trials for these conditions

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