Bladder cancer trial pits radiotherapy against standard immunotherapy
NCT ID NCT07268339
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This phase 3 trial compares radiotherapy with a radiosensitiser to the standard BCG immunotherapy for high-risk non-muscle invasive bladder cancer. About 328 patients will be randomly assigned to one of the two treatments after tumor removal. The goal is to see which approach better prevents cancer from coming back or getting worse.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- radiotherapy with radiosensitisation (gemcitabine, mitomycin C/fluorouracil, or carbogen/nicotinamide)
- What this could lead to
- If successful, this could offer a more effective alternative to BCG for high-risk bladder cancer, reducing recurrence and the need for bladder removal.
- What could go wrong
- This is an early-stage trial with 328 participants, and radiotherapy may cause side effects like bladder or bowel irritation. It may not prove superior to BCG.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 328 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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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
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16 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Diagnosed with histologically confirmed grade 3 T1 N0 M0 transitional cell carcinoma, OR carcinoma in situ of the bladder (and N0 M0), OR both, with detrusor muscle present in the biopsy specimen if T1 disease (or a repeat resection that does contain muscle that is clear) * Suitable for BCG treatment * Suitable for radiotherapy and radiosensitisation according to the schedule of administration outlined in the Radiotherapy Planning Guidance document. * Life expectancy over 12 months * ECOG performance status 0 - 2 * Age \>=16 years * Provided written informed consent Exclusion Criteria: * MDT selected patients with HR-NMIBC who are deemed best suited for primary cystectomy (patients that have had this treatment recommendation but then decline cystectomy remain eligible for TRAIN) * Previous radiotherapy to the pelvis * Previous intravesical therapy * Poor bladder function (IPSS \>16) * A recent or current other cancer. Current non-melanoma skin cancer, cervical carcinoma in situ or localized prostate cancer not requiring current treatment are permissible, as is a history of a separate other malignancy having completed all active treatment ≥2 years previously and without evidence of relapse * Pre-existing medical conditions that preclude treatment options in either trial arm * Patient currently recruited to another interventional trial or participation within an interventional clinical trial within 3 months of the point of registration within TRAIN. * Pregnant or breast-feeding * Not able to use appropriate adequate effective contraception during and for 3 months after the study
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
Contacts and locations
Locations
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The Christie
Manchester, M20 4BX, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Bladder cancer drug delivered directly: a new hope for BCG failures
- New bladder cancer drug enters first human tests
- New bladder gel could help patients avoid bladder removal surgery
- Urine test may spare bladder cancer patients from unnecessary second surgery
- New pill could fight bladder cancer when standard therapy fails