Prospective Study of Adjuvant Radiotherapy in High Risk Bladder Cancer.

NCT03718741 | Terminated DMC

• 1 other identifier: 2107
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective interventional study aims at evaluating the safety and efficacy of an adjuvant radiation treatment in cases of muscle-invasive bladder cancer, submitted to radical cystectomy and presenting clinic-pathological characteristics of high risk of recurrence.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Local Control Rate

  This prospective interventional study aims at evaluating the safety and efficacy of an adjuvant radiation treatment in cases of muscle-invasive bladder cancer, submitted to radical cystectomy and presenting clinic-pathological characteristics of high risk of recurrence.

  2 year

Secondary Outcomes (2)

• PFS

  2 years

• OS

  2 years

Study Arms (1)

Adiuvant Radiotherapy +/- CT

EXPERIMENTAL

The radiation treatment will be delivered with two possible schedules, according to the presence of positive margins on the pathology specimen: * R0: PTVb + PTVn 50 Gy in 25 fractions * R1-2: PTVn 50 Gy in 25 fractions. PTVb (including cystectomy bed and residual tumor when present) 55 Gy in 25 fractions with simultaneous integrated boost (SIB). Considering an alfa/beta of 10 for bladder tumor and 3 for healthy tissues the equivalent doses will be respectively: BED10: 60/67.1; EQD2: 50/55.92 Gy BED3: 83.33/95.33; EQD2: 50/57.20 Gy Patients with ECOG PS\<2, good haematological, hepatic and renal function (haemoglobin, neutrophil count, platelets, creatinine, glycaemia, Bilirubin, AST, ALT values within the limits of normal), will be submitted to concurrent cisplatin based weekly chemotherapy, 20-30 mg/m2, if they have not received neoadjuvant chemotherapy before surgery.

Radiation: Radiotherapy +/- CT

Interventions

Radiotherapy +/- CT RADIATION

Adiuvant Radiotherapy +/- weekly cisplatin

Adiuvant Radiotherapy +/- CT

Eligibility Criteria

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

You may qualify if:

• Age \>18 years
• Karnofsky index \> 60 % (ECOG \< 2)
• Histologically confirmed muscle-invasive bladder cancer (MIBC) submitted to radical cystectomy.
• Pathological T-stage \> pT3, and/or pathological N-stage \> pN1, and/or residual tumor present after surgery (R\>1)
• No distant metastases
• Written informed consent

You may not qualify if:

• Prior RT in the pelvic region
• Presence of distant metastases
• Pregnancy
• Inability to consent

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Clinical Trials Department

Model Details: Adiuvant Radiotherapy +/- CT

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: October 24, 2018
• Study Start: February 5, 2019
• Primary Completion: March 9, 2022
• Study Completion: March 9, 2022
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)