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Niraparib + Dostarlimab + Radiation for Rectal Cancer (TOPAZ Trial)
TOPAZ Trial Summary
This trial is designed to find the best dose of niraparib to combine with dostarlimab and hypofractionated radiation for locally advanced rectal cancer, and to see what effect this has on the tumor and patient reported outcome measures.
TOPAZ Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTOPAZ Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TOPAZ Trial Design
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Who is running the clinical trial?
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- I have not received a live vaccine in the last 14 days.I have had severe blood cell count issues from my last chemotherapy that lasted more than 4 weeks.I have had radiation therapy to my pelvic area before.I agree not to donate blood during and for 3 months after the study.My rectal cancer is advanced but can be surgically removed.I have not had a platelet transfusion in the last 4 weeks.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.My blood clotting time is longer than normal, but it's controlled with medication.My blood clotting time is longer than normal, but it's managed with my current anticoagulant therapy.I have active Crohn's disease or another type of inflammatory bowel disease.I am 18 years old or older.My colorectal cancer cannot be surgically removed without prior treatment.I have a history of lung scarring or fibrosis.I do not have any serious health issues that would prevent me from having a specific type of surgery.I have not had major surgery in the last 3 weeks.I haven't taken any experimental drugs within the last 4 weeks or 5 half-lives of the drug, whichever is shorter.I am mostly active and can carry out daily activities.I am advised to undergo radiation therapy before surgery.My cancer has spread to distant parts of my body.I am recommended to have intensive therapy before surgery.I do not have any serious infections that required hospital stay or delayed treatment.I haven't had treatment for another cancer type, except skin or treated cervical cancer, in the last 2 years.My kidney function is within the normal range.I have an immune system disorder or have taken immune-weakening medicines in the last week.I have had a severe reaction to previous immunotherapy, except for minor lab changes.I have a history of MDS or AML.I have not received colony stimulating factors in the last 4 weeks.I have had anti-PD-L1 or PARPi therapy, or I have a BRCA-1/2 gene mutation.
- Group 1: Cohort 1 (starting)
- Group 2: Cohort 2
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are volunteers still needed for this clinical trial?
"The information available on clinicaltrials.gov affirms that this trial is actively recruiting patients. The listing was first created on 7/7/2022 and has since been updated on 7/22/2022. At present, the study requires 38 participants at a single site."
What is the general consensus in the medical community about Short course radiation?
"There are 112 ongoing studies related to Short course radiation, with 14 of them in Phase 3. Many research centres for this topic are based in Washington D.C., but there are 3147 locations conducting trials globally."
What are researchers hoping to achieve with this clinical trial?
"The primary outcome of this study, according to GlaxoSmithKline, will be measured over a 21 week period starting from day one of treatment. This medical research is also investigating secondary outcomes like local recurrence free survival (defined as the time until disease progression or death), metastasis free survival (defined as the time until documented disease progression or death), and overall survival (the time from treatment day 1 until death)."
How many study participants are being treated with the experimental therapy?
"Yes, that is accurate. The trial was posted on 7/7/2022 and was last updated almost two weeks ago on 7/22/2022. They are currently 38 patients needed from 1 site."
When is it common to use radiation therapy for a short amount of time?
"While frequently used to treat primary peritoneal cancer, short course radiation can also be an effective treatment for advanced mismatch repair-deficient (dmmr) endometrial cancer, disease that has progressed during or following platinum-containing chemotherapy, and fallopian tubes cancer."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Holden Comprehensive Cancer Center at the University of Iowa: < 48 hours
Average response time
- < 2 Days
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