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Clinical Trials/EUCTR2018-003520-37-GB
EUCTR2018-003520-37-GB
Active, not recruiting
Phase 1

A multi-stage randomised trial of durvalumab (Medi4736) with chemoradiotherapy with 5-fluorouracil and mitomycin C in patients with muscle-invasive bladder cancer - Rad-IO

niversity of Birmingham0 sites159 target enrollmentAugust 22, 2019
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ConditionsMuscle invasive bladder cancerMedDRA version: 21.1Level: LLTClassification code 10022877Term: Invasive bladder cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsImfinziMitomycin C5-Fluorouracil

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Muscle invasive bladder cancer
Sponsor
niversity of Birmingham
Enrollment
159
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 22, 2019
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Age \>18 years old
  • •Body weight \>30 kg
  • •Histologically proven invasive bladder carcinoma (adenocarcinoma,
  • •transitional cell carcinoma or squamous cell carcinoma)
  • •Localised muscle invasive carcinoma either surgically or by imaging (T2\-
  • •T4a N0 M0\)
  • •World Health Organisation (WHO) performance status grade 0 to 1
  • •Adequate normal organ and marrow function as defined below:
  • •oHaemoglobin \=100 g/L
  • •oAbsolute neutrophil count 1\.5 x 109/L

Exclusion Criteria

  • •Uncontrolled systemic disease which would preclude the patient from
  • •participating in the trial including severe or uncontrolled
  • •cardiovascular disease
  • •Restrictive or obstructive disturbances to pulmonary ventilation, renal function or liver function
  • •Previous pelvic radiotherapy
  • •Bilateral hip replacements compromising accurate radiotherapy planning
  • •Evidence of significant clinical disorder, or laboratory finding which,
  • •in the opinion of the investigator, makes it undesirable for the patient
  • •to participate in the trial
  • •Widespread Carcinoma in situ (CIS), or CIS remote from the muscle

Outcomes

Primary Outcomes

Not specified

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