Role of NAC in cT0 Muscle-invasive Bladder Cancer After Maximal TURBt

Launched by REGINA ELENA CANCER INSTITUTE · Mar 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of two treatment options for patients with muscle-invasive bladder cancer who have had surgery to remove the tumor. Researchers want to find out if receiving chemotherapy before surgery (called neoadjuvant chemotherapy) helps patients live longer compared to having surgery alone. The trial focuses on patients who have no remaining visible cancer after surgery, and the main goal is to determine whether the chemotherapy offers any benefits or just delays treatment without improving survival.

Eligible participants are adults aged 18 and older who have been diagnosed with muscle-invasive bladder cancer but have no remaining tumor after their initial surgery. They should be able to undergo surgery and follow the study's requirements. Those who join the trial can expect to be randomly assigned to either receive chemotherapy before surgery or go straight to surgery. Throughout the study, participants will complete questionnaires about their quality of life. It's important to note that the trial is currently recruiting participants and aims to provide valuable insights into the best treatment approaches for this type of cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • diagnostic TURBt with cT2-4, cN0, cM0;
• • non-radiologic or endoscopic residual tumor after a maximal TURBt (cT0);
• • patients eligible to curative intent, candidate to surgical treatment and/or NAC (all patients must meet all the criteria required to be able to undergo RC and/or NAC);
• • ≥ 18 yrs old;
• • compliants patients able to follow the study protocol and fill in EORTC quality of life questionnaires;
• • patients able to provide a written informed consent for the trial
• Exclusion criteria:
• • anaesthesiologic contraindications to surgery;
• • palliative intent;
• • patients ineligible for cisplatin-combination chemotherapy