Evaluation of the Clinical Utility of Online Adaptive Radiotherapy in Bladder Cancer (BLADAPT-GETUG V11)

NCT07043543 | Not Yet Recruiting

• 1 other identifier: PROICM 2024-02 BLA
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 11

Brief Summary

Trimodal therapy (TMT) consisting of transurethral resection of bladder tumors followed by radiotherapy and chemotherapy is a therapeutic alternative in patients with Muscle-Infiltrating Bladder Cancer who are inoperable or refuse surgery. One of the main challenges of TMT is the planning and delivery of radiation therapy. Indeed, the bladder is a mobile hollow organ subject to repletion, with variations in size and shape during and between radiotherapy sessions. Standard radiotherapy techniques require large planning target volume margins around the bladder, which can be responsible for irradiation of a large volume of large and small bowel with grade 2 and 3 toxicities. Adaptive radiotherapy allows for the generation of a treatment fraction personalized to a patient's anatomical modification with margin reduction and improves the dosimetric quality of the delivered plans. The hypothesis is that this improvement results in radiation-induced toxicity improvement.

Conditions

Bladder Cancer

Keywords

Adaptive radiotherapy; standard radiotherapy; Tri-Modal therapy

Outcome Measures

Primary Outcomes (1)

• evaluation of the technique of adaptive radiotherapy in terms of acute Gastro-Intestinal toxicity.

  rate of patients without acute diarrhea grade ≥2

  from the Day 1 Radiotherapy to 3 months after the last day of Radiotherapy

Secondary Outcomes (12)

• Evaluation of all acute toxicities

  from the Day 1 Radiotherapy to 3 months after the last day of Radiotherapy

• Evaluation of all late toxicities

  from 3 months after the last day of Radiotherapy to 5 years after the last day of Radiotherapy

• evaluation of quality of life specific to the cancer disease

  at baseline, the last day of radiotherapy, every 3 months after the last day of radiotherapy, during first year and every 6 months then after until 3 years.

• evaluation of quality of life and of the measurements specific to the treatment of bladder cancer with muscle invasion

  at baseline, the last day of radiotherapy, every 3 months after the last day of radiotherapy, during first year and every 6 months then after until 3 years.

• evaluation of quality of life for patient ≥ 70 years old in order to establish a minimum standardized geriatric assessment

  at baseline, the last day of radiotherapy, every 3 months after the last day of radiotherapy, during first year and every 6 months then after until 3 years.

Study Arms (2)

experimental arm

EXPERIMENTAL

Adaptive radiotherapy +/- chemotherapy

Radiation: Adaptive radiotherapy

standard arm

ACTIVE COMPARATOR

Standard radiotherapy +/- chemotherapy

Radiation: standard radiotherapy

Interventions

Adaptive radiotherapy RADIATION

Patient will be treated by concomitant: * adaptive radiotherapy 5 days a week for 4 weeks with hypofractionated irradiation 55 Gy / 20 fractions +/- pelvic inclusion 44 Gy/20 fractions (SIB). * chemotherapy if not contraindicated : * Cisplatin : 20 mg/m2/day on day 1 to day 4 and day 22 to day 25 (or 80 mg/m2 during week 1 and 4 of radiotherapy) Or * Gemcitabine: 80 to 100 mg/m2/week Or * Mitomycin C: 12 mg/m2 on day 1 only + 5FU infusion 500 mg/m2/day during 5 days on week 1 and 4 of radiotherapy (alternatively : capecitabine taken twice daily at a dose of 825 per square meter per day on the days of radiotherapy)

experimental arm

standard radiotherapy RADIATION

Patient will be treated by concomitant: * standard 5 days a week for 4 weeks with hypofractionated irradiation 55 Gy / 20 fractions +/- pelvic inclusion 44 Gy/20 fractions (SIB). * chemotherapy if not contraindicated : * Cisplatin : 20 mg/m2/day on day 1 to day 4 and day 22 to day 25 (or 80 mg/m2 during week 1 and 4 of radiotherapy) Or * Gemcitabine: 80 to 100 mg/m2/week Or * Mitomycin C: 12 mg/m2 on day 1 only + 5FU infusion 500 mg/m2/day during 5 days on week 1 and 4 of radiotherapy (alternatively : capecitabine taken twice daily at a dose of 825 per square meter per day on the days of radiotherapy)

standard arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven muscle-infiltrating bladder cancer (de novo MIBC or after a history of non-muscle-invasive bladder cancer) or patients with initial high-grade T1 tumor showing Ta or T1 recurrence, or those with high-grade T1 after a course of intravesical biological therapy or chemotherapy;
• Age ≥ 18 years;
• Urothelial carcinoma (transitional cell carcinoma of the bladder, micropapillary, microcystic with trophoblastic differenciation) and squamous cell histological types are allowed;
• Stage T1-T4aN0M0
• Suitable for radiotherapy;
• Eastern Cooperative Oncology Group/World Human Organisation (ECOG/WHO) performance status from 0 to 2
• Negative pregnancy test (blood or urine), for women of childbearing age only;
• If the patient is sexually active, he/she must agree to use contraception deemed adequate and appropriate by the investigator throughout the period of study drug administration and 6 months after the end of treatment for both men and women.
• Affiliation to the French Social Security System;
• Dated, written and signed Informed consent

You may not qualify if:

• Prior pelvic radiation therapy;
• Patients with previous or concomitant other malignancy within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease free for at least five years;
• Presence of endopenic stent;
• Inability to comply with the protocol;
• Grade 1 or greater baseline diarrhea;
• Uncontrolled inflammatory bowel disease (ulcerative colitis or Crohn's disease);
• Uncontrolled immune or cardiac or pulmonary disease;
• Patients whose regular follow-up is impossible for psychological, family, social or geographical reasons;
• Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study;
• Pregnant or breast-feeding subjects

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead
• Ligue contre le cancer, France: collaborator

Study Sites (11)

Centre Georges François Leclerc

Dijon, Côte d'or, 21079, France

Location

Institut du Cancer de Montpellier

Montpellier, Herault, 34298, France

Location

Centre Eugène Marquis

Rennes, Ille et Vilaine, 35000, France

Location

Institut de Cancérologie de l'Ouest

Saint-Herblain, Loire Atlantique, 44800, France

Location

Centre Oscar Lambret

Lille, Nord, 59000, France

Location

Centre de radiothérapie Bayard

Villeurbanne, Rhone, 69100, France

Location

Centre Henri Becquerel

Rouen, Seine Maritime, 76038, France

Location

Institut Sainte Catherine

Avignon, Var, 84000, France

Location

Centre de radiothérapie Saint-Louis

Toulon, Var, 83100, France

Location

Hôpital Tenon

Paris, Île-de-France Region, 75020, France

Location

Institut Curie

Saint-Cloud, Île-de-France Region, 92210, France

Location

Related Publications (42)

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Related Links

• incidence et de la mortalité par cancer en France métropolitaine

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Olivier RIOU, MD

  INSTITUT REGIONAL DU CANCER DE MONTPELLIER

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurore MOUSSION

CONTACT

467613102; aurore.moussion@icm.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 29, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): January 30, 2029
• Study Completion (Estimated): September 30, 2033
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (11)