Study 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.
- Rectal Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 6 Secondary · Reporting Duration: 3 months post-radiation
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Cohort 2
1 of 2
Cohort 1 (starting)
1 of 2
Experimental Treatment
38 Total Participants · 2 Treatment Groups
Primary Treatment: Short course radiation · No Placebo Group · Phase 1 & 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| North Carolina | 100.0% |
What site did they apply to?
| Holden Comprehensive Cancer Center at the University of Iowa | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
Why did patients apply to this trial?
- "Wanted to try other options"
How many prior treatments have patients received?
| 1 | 100.0% |
How responsive is this trial?
Typically responds via
| Phone Call | 100.0% |
Most responsive sites:
- Holden Comprehensive Cancer Center at the University of Iowa: < 48 hours
Average response time
- < 2 Days
- Seyedin, Steven N., M.M. Hasibuzzaman, Vivan Pham, Michael S. Petronek, Cameron Callaghan, Amanda L. Kalen, Kranti A. Mapuskar, et al.. 2020. “Combination Therapy with Radiation and PARP Inhibition Enhances Responsiveness to Anti-pd-1 Therapy in Colorectal Tumor Models”. International Journal of Radiation Oncology*biology*physics. Elsevier BV. doi:10.1016/j.ijrobp.2020.01.030.
- Joseph Caster, Ph.D., M.D. 2022. "A Safety Study Adding Niraparib and Dostarlimab to Radiation Therapy for Rectal Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04926324.
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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)." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor