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New drug combo aims to save bladders in cancer fight

NCT ID NCT01495676

Disease control Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial tested whether adding gemcitabine to standard cisplatin and radiation therapy could help control muscle-invasive bladder cancer while preserving the bladder. About 69 patients were enrolled to compare the combination against standard treatment. The study was terminated early, so firm conclusions are limited.

What this could mean

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

Active substance
gemcitabine and cisplatin
What this could lead to
If successful, this could offer a bladder-sparing treatment option for muscle-invasive bladder cancer, avoiding the need for radical surgery.
What could go wrong
This trial was terminated early with only 69 participants, so results are limited. The combination may increase side effects without improving disease control.

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

69 people

The number who actually took part.

Started

Jul 2011

Finished

Dec 2024

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: * Muscle invasive urothelial cancer (front line or following the progression of a superficial tumor), pT2-pT3 stage without lymphatic impairment (N0) and without detectable metastases (M0). An optimal macroscopic resection (TURB) have to be performed * The proof of invasive tumor to the muscle should be brought by a transurethral resection under anaesthesia less than 8 weeks before or, in the absence, by superficial biopsies and formal imaging. Multiples biopsies in the bladder must also be performed. * Age ≥ 18 years * Life expectancy ≥ 6 months * Kanorfsky index ≥ 70 % (WHO 0, 1, 2) * Biological criteria: neutrophils ≥ 1500/mm3, Platelets ≥ 100 000/mm3, haemoglobin ≥ 10 g/dl, creatinine clearance \> 60 ml/mn * No distant metastases (Thorax, abdomen, and pelvic CT-scan, bone scan) * Efficient contraception for premenopausal women, maintained during the whole treatment and up to two months after the completion of radiotherapy. * No radiotherapy or chemotherapy history except for in situ bladder lesions. * No carcinological history except for non melanoma skin tumours, in situ uterine cervix cancer * No contraindication to gemcitabine or cisplatin. * No contraindication to radiotherapy * Information letter and informed consent signed * Patient covered by social security Exclusion Criteria: * Bladder tumors without any muscle infiltration * Epidermoid carcinoma or adenocarcinoma * Distance metastases or extrapelvic node positivity * Severe digestive history (ulcerative colitis, complicated diverticulitis) * Pregnancy and breast feeding

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Conditions

The condition(s) this trial relates to.

infiltrating bladder urothelial carcinoma Urinary Bladder Neoplasms

As listed by the trial registrant

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

Infiltrating bladder urothelial carcinoma

Contacts and locations

Locations

  • CRLC GF Leclerc

    Dijon, 21000, France

  • CRLC Val d'Aurelle-Paul Lamarque

    Montpellier, 34000, France

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511, France

  • Centre Antoine Lacassagne

    Nice, 06189, France

  • Centre Francois Baclesse

    Caen, 14000, France

  • Centre azuréen de Cancérologie

    Mougins, 06250, France

  • Clinique Patseur

    Toulouse, 31300, France

  • HEGP

    Paris, 75015, France

  • Hopital Henri Mondor

    Créteil, 94010, France

  • Hopital saint Louis

    Paris, 75010, France

  • Institut Bergonié

    Bordeaux, 33000, France

  • Institut de Cancérologie Lucien Neuwirth

    Saint-Priest-en-Jarez, 42705, France

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