Ovarian-Sparing Radiotherapy for Uterine and Rectal Cancer
(OvAR-Y Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial seeks new methods to protect the ovaries during pelvic radiation therapy, often required for cancers such as uterine or rectal cancer. Radiation can cause premature ovarian failure, leading to heart, bone, and emotional health issues. The trial evaluates an adaptive radiotherapy approach to safeguard the ovaries without surgery. Women under 50 who have regular periods and plan to undergo radiation therapy might be suitable candidates.
As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to potentially groundbreaking advancements in cancer care.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this technique is safe for ovarian function preservation?
Research has shown that adaptive radiotherapy, like the one being tested, is generally safe for patients. A small initial study found that this treatment had acceptable side effects, with no severe harmful reactions reported. Another study demonstrated that daily adjustments to the treatment improved planning and resulted in low short-term side effects, indicating it was well-tolerated.
These findings suggest that the ovarian-sparing adaptive radiotherapy being tested could be safe for participants, with manageable side effects. However, further research is needed to confirm safety for everyone.12345Why are researchers excited about this trial?
Researchers are excited about Ovarian-Sparing Adaptive Radiotherapy because it offers a tailored approach to preserving ovarian function in young adult women undergoing radiation treatment. Unlike traditional radiation therapy, which can damage the ovaries, this method utilizes advanced imaging techniques to precisely target the cancerous area while minimizing exposure to the ovaries. The use of HyperSight CBCT imaging allows for real-time adjustments, ensuring that the ovaries are well-protected during each session. This innovative approach has the potential to maintain fertility and hormonal function, which is a significant advantage over current standard treatments.
What evidence suggests that ovarian-sparing adaptive radiotherapy is effective for protecting ovarian function?
Research shows that ovarian-sparing adaptive radiotherapy, which participants in this trial will receive, can protect the ovaries during pelvic cancer treatment. This method uses advanced imaging to adjust radiation in real-time, focusing on the tumor while avoiding healthy tissues like the ovaries. Studies have found that this approach can help maintain ovarian function while still treating the cancer. By targeting radiation more precisely, fewer side effects are expected. This technique is especially important for younger women who risk early menopause with traditional radiation methods. Initial findings suggest that this method could be a promising option for those wanting to preserve fertility and avoid early ovarian failure.678910
Who Is on the Research Team?
Michael Waters, M.D., Ph.D.
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation
Participants undergo ovarian-sparing adaptive radiotherapy with a 25 Gy / 5 fx rectal plan
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ovarian-Sparing Adaptive Radiotherapy
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
A 25 Gy / 5 fx rectal plan for all patients, irrespective of their primary malignancy, will be created as per institutional standards. Patients may undergo treatment on any radiation therapy machine but will have their pelvis images on a HyperSight CBCT machine after consent while they receive their treatment. In general, patients will be imaged with 2 CBCTs approximately 10 minutes apart, each imaging session / day. However, only one CBCT per treatment session is required, and a patient may have between 1 to 10 scans total throughout 1 to 5 imaging sessions. In general, if ovaries are well visualized then only 1 or 2 imaging sessions will be completed.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
Varian Medical Systems
Industry Sponsor
Dow R. Wilson
Varian Medical Systems
Chief Executive Officer since 2012
MBA from Dartmouth's Amos Tuck School of Business, BA from Brigham Young University
Dr. Deepak Khuntia
Varian Medical Systems
Chief Medical Officer since 2020
MD from the University of Cambridge, PhD from the University of Leicester
Citations
Ovarian-Sparing Adaptive Radiotherapy in Young Adult ...
Ovarian transposition carries variable success rates, is not readily accessible to the general population, and can still be at risk of ...
The New Kid on the Block: Online Adaptive Radiotherapy ...
Adaptive radiotherapy is able to account for these changes in tumor size and potentially treat less normal tissue while maintaining tumor ...
3.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT06904365/ovarian-sparing-adaptive-radiotherapy-in-young-adult-women?id=1014&slug=leiomyomasOvarian-Sparing Adaptive Radiotherapy in Young Adult ...
Study Summary. Female patients with early onset (<50 years old) pelvic malignancies such as uterine and rectal cancers are rising in incidence, ...
Online Adaptive Magnetic Resonance-guided Radiation ...
The estimated 1-year overall survival was 88.9%. The median treatment time was 47 days (range 10–87 days). During external beam radiation therapy, 10 (83.3%) ...
Ovarian-Sparing Adaptive Radiotherapy in Young Adult
This clinical trial is looking at a new way to protect the ovaries of young women who need radiation therapy for certain cancers, such as uterine or rectal ...
Optimal timing of organs-at-risk-sparing adaptive radiation ...
The purpose of this study was to determine the personalized optimal timing of re-planning in adaptive OAR-sparing radiation therapy, considering limited re- ...
Adaptive radiotherapy, promises and pitfalls
A pilot study has shown that MR-guided radiotherapy was safe in this setting, with acceptable toxicity (no toxicity grade 3 or above reported) [30]. 3.1.4.
Clinical Outcomes of Online Adaptive Magnetic Resonance ...
Twenty-five patients (71.4%) had tumor progression during follow-up. The median PFS was 5.1 months (95% CI: 2.9–7.2 months). The 1-year PFS was ...
MR-Guided Adaptive Radiotherapy for OAR Sparing in ...
Outcomes of interest for this clinical trial include xerostomia occurrence, locoregional control and overall survival. 6.3. INSIGHT-2— ...
Dosimetric Outcomes, Acute Toxicity, and First Clinical ...
Daily oART was associated with favorable dosimetry improvement and low acute toxicity, supporting its safety and efficacy for postoperative ...
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