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Prospective Study of Adjuvant Radiotherapy in High Risk Bladder Cancer. (Bladder-Aid)

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ClinicalTrials.gov Identifier: NCT03718741
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Michele Tedeschi, Istituto Clinico Humanitas

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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Radiation: Radiotherapy +/- CT Phase 2

Detailed Description:

Bladder cancer represents the ninth neoplasm in the world, with approximately 430,000 new cases diagnosed in 2012. Of them, around 118,000 were diagnosed in Europe, and 52,000 had died from this disease.

Patients with advanced bladder cancer (stage ≥pT3) have a five-year overall survival of ~50% after cystectomy and pelvic lymphadenectomy +/− chemotherapy with approximately half of recurrences in the pelvis, either as isolated failures or synchronous with distant metastases. In fact, radical cystectomy with or without chemotherapy has a 5-year overall survival of approximately 60% for patients with pathologic T2 disease confined to the bladder but only 10-40% for stage ≥pT3 when disease extends into the extravesicular tissues.

Pelvic failures after radical cystectomy are common, especially for ≥pT3 urothelial carcinoma with a cumulative incidence of locoregional failure of 32% at 5 years in the SWOG 8710 cohort. Adjuvant radiation therapy (RT) can reduce locoregional failure and may even improve overall survival, but currently has no defined role, in part because of toxicity reported in older series using 1980s radiation techniques.

An externally validated risk stratification to identify patients at highest risk for local-regional failure who are most likely to benefit from adjuvant RT has been developed based on pathologic T-stage, surgical margin status, and extent of the lymph node dissection.

Local-regional recurrence following radical cystectomy for patients with locally advanced urothelial carcinoma is common. The risk of local-regional recurrence is not diminished with chemotherapy, and salvage treatment is rarely successful. Adjuvant RT can reduce locoregional failure and may even improve overall survival, but currently has no defined role, in part because of toxicity reported in older series using 1980s radiation techniques. Several lines of evidence support the hypothesis that improved local control may lead to improved disease-free and overall survival.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Adiuvant Radiotherapy +/- CT
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Study of Adjuvant Radiotherapy in High Risk Bladder Cancer.
Actual Study Start Date : February 5, 2019
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: Adiuvant Radiotherapy +/- CT

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
Adiuvant Radiotherapy +/- weekly cisplatin




Primary Outcome Measures :
  1. Local Control Rate [ Time Frame: 2 year ]
    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.


Secondary Outcome Measures :
  1. PFS [ Time Frame: 2 years ]
    Progression Free Survival

  2. OS [ Time Frame: 2 years ]
    Overall survival



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03718741


Contacts
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Contact: Giuseppe D'Agostino, MD +39 0282247301 giuseppe.dagostino@humanitas.it
Contact: Lucia Di Brina, MD +39 0282247585 lucia.dibrina@humanitas.it

Locations
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Italy
Istituto Clinico Humanitas Recruiting
Rozzano, Milano, Italy, 20089
Contact: Giuseppe D'Agostino, MD         
Sponsors and Collaborators
Istituto Clinico Humanitas

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Responsible Party: Michele Tedeschi, Head of Clinical Trials Department, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT03718741     History of Changes
Other Study ID Numbers: 2107
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases