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SG + Radiation Therapy for Bladder Cancer
Phase 1
Recruiting
Led By Omar Mian, MD, PhD
Research Sponsored by Omar Mian
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Performance status: ECOG Performance status ≤ 2
Participants must have histologically or cytologically confirmed muscle-invasive bladder cancer (MIBC) (T2-T4aN0M0). Participants with mixed urothelial carcinoma will be eligible for the trial, except for small cell or neuroendocrine component
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 6 months
Awards & highlights
Study Summary
This trial explores the safety and tolerability of a drug (SG) combined with radiation therapy to help treat localized bladder cancer. Patients receive SG for 3 cycles during 8 weeks of treatment, then monitored for up to 5 years.
Who is the study for?
This trial is for adults with muscle-invasive bladder cancer (MIBC) that's not spread beyond the bladder. They should have had a tumor removal surgery recently and no prior systemic chemotherapy for MIBC. Participants must be in good health otherwise, with normal organ function, and not pregnant or breastfeeding. Those who've received other recent investigational treatments or have certain medical conditions are excluded.Check my eligibility
What is being tested?
The study tests combining Sacituzumab Govitecan (SG), an IV drug given on specific days of a treatment cycle, with adaptive radiation therapy to see if it's safe and can help preserve the bladder. The trial includes initial SG treatment before starting radiation therapy, followed by two more cycles during radiation.See study design
What are the potential side effects?
Potential side effects include reactions related to infusion of SG such as nausea, fatigue, hair loss; plus typical risks from radiation like skin irritation and discomfort near the treated area. Organ-specific inflammation might also occur due to either treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
Select...
My bladder cancer is invasive but hasn't spread beyond my pelvis.
Select...
My blood tests show normal liver, kidney, and bone marrow function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of acute-dose limiting toxicities
Secondary outcome measures
Determine the bladder intact event-free survival (BI-EFS)
Other outcome measures
Characterize imaging changes
Characterize immune repertoire editing
Characterize tumor clonal dynamics
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: SG + Adaptive radiotherapyExperimental Treatment2 Interventions
Sacituzumab Govitecan, IV, 8 mg/kg, 21-day cycles for 1 loading cycle prior to radiation and two subsequent cycles with concurrent adaptive radiotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sacituzumab govitecan
2017
Completed Phase 3
~530
Adaptive Radiotherapy
2007
Completed Phase 2
~160
Find a Location
Who is running the clinical trial?
Omar MianLead Sponsor
1 Previous Clinical Trials
4 Total Patients Enrolled
Varian IncUNKNOWN
Gilead SciencesIndustry Sponsor
1,084 Previous Clinical Trials
848,242 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had bladder cancer or related types outside the bladder in the last 2 years, except for specific early-stage cancers if I had complete surgery.I do not have any uncontrolled illnesses that could interfere with the study.My bladder functions well enough for preservation, with no severe blockages due to the tumor.I haven't had chemotherapy for my condition and I'm not going for or can't have cystectomy now.I've had recent scans of my chest, abdomen, and pelvis showing no advanced cancer.I can take care of myself but might not be able to do heavy physical work.I have had treatments like chemotherapy or radiation for bladder cancer, but treatments directly into the bladder are okay.I have issues controlling my bladder, including needing help to urinate.My bladder cancer is invasive but hasn't spread beyond my pelvis.My blood tests show normal liver, kidney, and bone marrow function.My tumor was removed as much as possible by my doctor.I am not pregnant or breastfeeding.I had or will have a bladder tumor removal surgery within the last 60 days.I have had radiation therapy in the pelvic area for bladder cancer or another type of cancer.I have been diagnosed with swelling in both kidneys.
Research Study Groups:
This trial has the following groups:- Group 1: SG + Adaptive radiotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it still possible to join this medical trial?
"The trial listing on clinicaltrials.gov reveals that this study is not currently enrolling participants, although it was originally posted in June of 2023 and last edited April 18th of the same year. However, 2774 other trials are actively recruiting patients at present."
Answered by AI
Is there a high risk associated with utilizing SG + Adaptive radiotherapy?
"Our team at Power has assessed that SG + Adaptive radiotherapy is relatively safe, giving it a score of 1 due to the fact that this trial is in its Phase 1 stage and there are only preliminary data points supporting efficacy."
Answered by AI
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