Hypofractionated Radiation Therapy for Endometrial Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Teresa Meier
Must not be taking: Investigational agents
Disqualifiers: Inflammatory bowel disease, Periaortic disease, others
Stay on Your Current Meds
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?Studying adjuvant hypofractionated whole pelvis radiation therapy in Endometrial Cancer.
Do I need to stop my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What data supports the effectiveness of the treatment Hypofractionated Whole Pelvis Radiation Therapy for Endometrial Cancer?
Research on hypofractionated radiation therapy in prostate cancer suggests that it can be effective and well-tolerated, with potential benefits in shortening treatment time and maintaining low side effects. Although specific data for endometrial cancer is limited, similar techniques in prostate cancer show promise for improving outcomes with manageable side effects.
12345Is hypofractionated whole pelvis radiation therapy safe for humans?
Research on hypofractionated whole pelvis radiation therapy, particularly in prostate cancer, suggests that it generally has low levels of side effects when compared to traditional radiation therapy. However, it is still considered investigational, and more studies are needed to fully understand its safety profile.
13456How is hypofractionated radiation therapy different for endometrial cancer treatment?
Hypofractionated radiation therapy for endometrial cancer involves delivering higher doses of radiation in fewer sessions compared to traditional radiation therapy, potentially reducing the overall treatment time while maintaining effectiveness. This approach is being explored for its ability to spare healthy tissues and reduce side effects, similar to its use in other cancers like prostate and breast cancer.
12378Eligibility Criteria
This trial is for adults over 18 with stage I, II, or III endometrial cancer who've had a hysterectomy and possibly lymph node removal. It's suitable for those needing pelvic radiation but not vaginal cuff brachytherapy due to anatomy or higher risk of nodal recurrence. Participants must be in good general health (ECOG ≤2) and able to consent.Inclusion Criteria
I am 18 years old or older.
I have stage I, II, or III endometrial cancer and need pelvic radiation as advised by my oncologist.
Ability to understand and the willingness to sign a written informed consent document.
+3 more
Exclusion Criteria
I have been diagnosed with Inflammatory Bowel Disease.
I have active disease in the nodes around my aorta confirmed by surgery.
I have had pelvic radiotherapy before.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Radiation
Participants receive hypofractionated whole pelvis radiation therapy to determine the maximum tolerated dose per fraction
3 months
15 sessions for Cohort 1, 10 sessions for Cohort 2
Follow-up
Participants are monitored for safety and effectiveness after radiation therapy, focusing on acute gastrointestinal and genitourinary toxicity
3 months
Participant Groups
The study tests hypofractionated whole pelvis radiation therapy as an additional treatment after surgery for endometrial cancer patients. The goal is to see if this type of targeted radiation can effectively treat the area around where the tumor was located.
1Treatment groups
Experimental Treatment
Group I: Hypofractionated Whole-Pelvis RadiotherapyExperimental Treatment1 Intervention
Hypofractionated WPRT Cohort 1: 41.25 Gy in 15 fx Cohort 2: 38 Gy in 10 fx
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Cincinnati Medical CenterCincinnati, OH
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Who Is Running the Clinical Trial?
Teresa MeierLead Sponsor
References
Dosimetric comparison of postoperative whole pelvic radiotherapy for endometrial cancer using three-dimensional conformal radiotherapy, intensity-modulated radiotherapy, and helical tomotherapy. [2010]The use of Intensity-modulated radiotherapy (IMRT) and Helical tomotherapy (HT) is increasing in gynecological cancer patients. No published studies have performed a dosimetric evaluation of whole pelvic radiotherapy (WPRT) using HT for postoperative endometrial cancer. The purpose of this study was to perform a direct dosimetric comparison of three-dimensional conformal radiotherapy (3D-CRT), IMRT and HT plans for WPRT in postoperative endometrial cancer patients, and to evaluate the integral dose to organs at risk (OARs) and normal tissue.
Effective Organs-at-Risk Dose Sparing in Volumetric Modulated Arc Therapy Using a Half-Beam Technique in Whole Pelvic Irradiation. [2022]Although there are some controversies regarding whole pelvic radiation therapy (WPRT) due to its gastrointestinal and hematologic toxicities, it is considered for patients with gynecological, rectal, and prostate cancer. To effectively spare organs-at-risk (OAR) doses using multi-leaf collimator (MLC)'s optimal segments, potential dosimetric benefits in volumetric modulated arc therapy (VMAT) using a half-beam technique (HF) were investigated for WPRT.
Whole-pelvic nodal radiation therapy in the context of hypofractionation for high-risk prostate cancer patients: a step forward. [2022]Given the low α/β ratio of prostate cancer, prostate hypofractionation has been tested through numerous clinical studies. There is a growing body of literature suggesting that with high conformal radiation therapy and even with more sophisticated radiation techniques, such as high-dose-rate brachytherapy or image-guided intensity modulated radiation therapy, morbidity associated with shortening overall treatment time with higher doses per fraction remains low when compared with protracted conventional radiation therapy to the prostate only. In high-risk prostate cancer patients, there is accumulating evidence that either dose escalation to the prostate or hypofractionation may improve outcome. Nevertheless, selected patients who have a high risk of lymph node involvement may benefit from whole-pelvic radiation therapy (WPRT). Although combining WPRT with hypofractionated prostate radiation therapy is feasible, it remains investigational. By combining modern advances in radiation oncology (high-dose-rate prostate brachytherapy, intensity modulated radiation therapy with an improved image guidance for soft-tissue sparing), it is hypothesized that WPRT could take advantage of recent results from hypofractionation trials. Moreover, the results from hypofractionation trials raise questions as to whether hypofractionation to pelvic lymph nodes with a high risk of occult involvement might improve the outcomes in WPRT. Although investigational, this review discusses the challenging idea of WPRT in the context of hypofractionation for patients with high-risk prostate cancer.
Is hypofractionated whole pelvis radiotherapy (WPRT) as well tolerated as conventionally fractionated WPRT in prostate cancer patients? The HOPE trial. [2021]Patients with high-risk prostate cancer are at increased risk of lymph node metastasis and are thought to benefit from whole pelvis radiotherapy (WPRT). There has been recent interest in the use of hypofractionated radiotherapy in treating prostate cancer. However, toxicity and cancer outcomes associated with hypofractionated WPRT are unclear at this time. This phase II study aims to investigate the impact in quality of life associated with hypofractionated WPRT compared to conventionally fractionated WPRT.
The early result of whole pelvic radiotherapy and stereotactic body radiotherapy boost for high-risk localized prostate cancer. [2020]The rationale for hypofractionated radiotherapy in the treatment of prostate cancer is based on the modern understanding of radiobiology and advances in stereotactic body radiotherapy (SBRT) techniques. Whole-pelvis irradiation combined with SBRT boost for high-risk prostate cancer might escalate biologically effective dose without increasing toxicity. Here, we report our 4-year results of SBRT boost for high-risk localized prostate cancer.
Assessing the toxicity after moderately hypofractionated prostate and whole pelvis radiotherapy compared to conventional fractionation. [2023]To evaluate acute and late gastrointestinal (GI) and genitourinary (GU) toxicities after moderately hypofractionated (HF) or conventionally fractionated (CF) primary whole-pelvis radiotherapy (WPRT).
Hypofractionated radiotherapy for the palliation of advanced pelvic malignancy. [2019]Forty-two patients, with a variety of advanced pelvic malignancies, have been treated with a hypofractionated radiotherapy regimen. The most common schedule was 30 Gy in three fractions at monthly intervals. This has provided effective palliation with acceptable morbidity in the select patient group treated. The results in advanced rectal and ovarian tumors were particularly encouraging. The most effective dose/fraction and interfraction interval is, at present, under active investigation within our institution.
Hypofractionated radiotherapy for breast cancer patients treated by breast-conserving surgery: short-term morbidity and preliminary results. [2018]Hypofractionated adjuvant radiotherapy (RT) in breast cancer patients treated by conservative surgery has been increasingly used in recent years. We present our experience regarding tolerance/acute toxicity of a hypofractionated RT schedule.