EFFORT-MIBC: Evaluating the Impact of FDG-PET-CT on Risk Stratification and Treatment Adaptation for Patients With Muscle Invasive Bladder Cancer

Sponsor

University Hospital, Ghent (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04724928

Collaborator

(none)

156

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

To evaluate the impact of 18F-FDG-PET-CT on the staging of patients with muscle invasive bladder cancer. Based on the results of 2 18F-FDG-PET-CT's patients are stratified in non-metastatic, oligometastatic and polymetastatic bladder cancer patients and the treatment is adapted accordingly to improve overall survival.

Condition or Disease	Intervention/Treatment	Phase
Muscle-Invasive Bladder Carcinoma Oligometastatic Disease	Radiation: metastasis directed therapy (MDT) Drug: Immunotherapy	Phase 2

Detailed Description

Only patients presenting with non-metastatic MIBC on conventional CT scan are eligible for the trial.

Additionally, 2 18F FDG-PET-CT scans per patient will be performed, prior and after neo-adjuvant chemotherapy. All patients will have a radical treatment to the bladder either by radical cystectomy or trimodality therapy.

In case of diagnosis of oligometastatic disease on 1 of both FDG-PET-CT's, a metastasis directed therapy to the oligometastatic sites will be added.

In case of polymetastatic disease on FDG-PET-CT, additional immunotherapy will be administered (this is standard of care after chemotherapy failure)

Study Design

Study Type:

Interventional

Anticipated Enrollment :

156 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Prospective Trial to Evaluate the Impact of 18F-FDG-PET-CT in Stratifying Patients With Muscle Invasive Bladder Cancer and Tailoring the Treatment Accordingly

Anticipated Study Start Date :

Feb 1, 2021

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: non-metastatic MIBC on PET-CT patients receive classical treatment with neo-adjuvant chemotherapy followed by radical cystectomy (RC) or trimodality therapy (TMT) and regular follow up
Experimental: oligo-metastatic MIBC on PET-CT patients receive classical treatment with neo-adjuvant chemotherapy followed by RC or trimodality therapy TMT and metastasis-directed therapy followed by regular follow up	Radiation: metastasis directed therapy (MDT) MDT in case of oligometastases
Experimental: poly-metastatic MIBC on PET-CT patients receive classical treatment with neo-adjuvant chemotherapy followed by RC or trimodality therapy TMT and start of immunotherapy followed by regular follow up	Drug: Immunotherapy immunotherapy in the setting of polymetastatic disease

Arm

Intervention/Treatment

No Intervention: non-metastatic MIBC on PET-CT

patients receive classical treatment with neo-adjuvant chemotherapy followed by radical cystectomy (RC) or trimodality therapy (TMT) and regular follow up

Experimental: oligo-metastatic MIBC on PET-CT

patients receive classical treatment with neo-adjuvant chemotherapy followed by RC or trimodality therapy TMT and metastasis-directed therapy followed by regular follow up

Radiation: metastasis directed therapy (MDT)

MDT in case of oligometastases

Experimental: poly-metastatic MIBC on PET-CT

patients receive classical treatment with neo-adjuvant chemotherapy followed by RC or trimodality therapy TMT and start of immunotherapy followed by regular follow up

Drug: Immunotherapy

immunotherapy in the setting of polymetastatic disease

Outcome Measures

Primary Outcome Measures

survival [24 months]
2-years overall survival

Secondary Outcome Measures

side effects [3 months]
side effects [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

newly diagnosed MIBC with no signs of metastasis on conventional imaging (i.e. CT)

Exclusion Criteria:

Extra-pelvic metastasis (M1 disease) on conventional imaging (CT thorax/abdomen/MRI)
Prior RT enabling MDT
Contra-indication for 18F FDG PET-CT
Contraindications to radiotherapy (including active inflammatory bowel disease)
No prior Cisplatin-based chemotherapy in the neo-adjuvant setting
Patient refusing 18F FDG PET-CT
Patient refusing MDT or immunotherapy
Other primary tumour diagnosed <5 years ago and for which treatment is still required

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Ghent

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Ghent

ClinicalTrials.gov Identifier:

NCT04724928

Other Study ID Numbers:

86702020000105

First Posted:

Jan 26, 2021

Last Update Posted:

Jan 26, 2021

Last Verified:

Aug 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Ghent

PET-CT

Additional relevant MeSH terms:

Urinary Bladder Neoplasms

Study Results

No Results Posted as of Jan 26, 2021