Hypofractionated Radiotherapy for Endometrial and Cervical Cancers
(HERA Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Jonsson Comprehensive Cancer Center
Disqualifiers: Concurrent chemotherapy, Active malignancy, Prior irradiation, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?After surgery to remove the main endometrial and/or cervical tumor, most women receive radiation therapy. This study uses hypo-fractionated radiation therapy, which is a type of radiation therapy in which the total prescribed dose of radiation is delivered in fewer but larger doses than conventional or standard radiotherapy.
This research study aims to determine if hypo-fractionated radiation therapy given after surgery can improve treatment tolerability (i.e., fewer treatments) with comparable side effects.
Participants will be in the study for about 5 years:
Radiation therapy:
* 5 daily treatment sessions of MRI or CT-Guided Stereotactic Body Radiation Therapy (SBRT).
* Each treatment session will occur on a weekday (typically consecutive weekdays) and will last approximately an hour.
Treatment Follow-Up:
* Check-up Appointment and answer questions at 3 months post RT
* Check-up Appointments with physical exam every 6 months (+/- 4 weeks) for up to 5 years.
Will I have to stop taking my current medications?
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 data supports the effectiveness of this treatment for endometrial and cervical cancers?
Research shows that stereotactic ablative radiation therapy (SABR) and stereotactic body radiation therapy (SBRT) have been effective and safe alternatives for cervical cancer patients who cannot undergo traditional brachytherapy, suggesting potential benefits for similar treatments in endometrial and cervical cancers.
12345Is hypofractionated radiotherapy generally safe for humans?
Hypofractionated radiotherapy, including stereotactic body radiation therapy (SBRT) and stereotactic ablative radiotherapy (SABR), has been shown to be safe in treating conditions like early-stage lung cancer and low-risk prostate cancer, with studies reporting on long-term safety and patient-reported outcomes.
46789How is hypofractionated radiotherapy different from other treatments for endometrial and cervical cancers?
Hypofractionated radiotherapy is unique because it delivers higher doses of radiation in fewer sessions compared to traditional radiation therapy, which can be more convenient and potentially more effective for some patients. It uses advanced techniques like stereotactic body radiation therapy (SBRT) to precisely target tumors, making it a good option for patients who cannot undergo standard brachytherapy.
1231011Eligibility Criteria
This trial is for women who have had surgery to remove endometrial or cervical cancer. They should be candidates for post-surgery radiation therapy and able to undergo MRI or CT scans. Specific details about inclusion and exclusion criteria are not provided, but typically participants must meet certain health standards.Inclusion Criteria
I am 18 years old or older.
I can care for myself but may not be able to do active work.
My cancer diagnosis is confirmed for either endometrial or cervical cancer.
+2 more
Exclusion Criteria
I am not required to have chemotherapy as part of my standard treatment.
I am currently being treated for another cancer.
I have had radiation therapy to the area that needs treatment now.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive 5 fractions of MRI or CT-Guided Stereotactic Body Radiation Therapy (SBRT) with adaptive planning, delivered once every other day excluding weekends and holidays
2 weeks
5 visits (in-person)
Initial Follow-up
Participants have a check-up appointment and answer questions at 3 months post-radiotherapy
3 months
1 visit (in-person or virtual)
Long-term Follow-up
Participants have check-up appointments with physical exams every 6 months for up to 5 years post-radiotherapy
5 years
10 visits (in-person or virtual)
Participant Groups
The study tests hypo-fractionated external beam radiotherapy after surgery in women with endometrial or cervical cancers. This approach uses fewer, larger doses of radiation compared to the standard method, aiming to maintain effectiveness while reducing treatment time.
1Treatment groups
Experimental Treatment
Group I: Hypofractionated External beam RadiotherapyExperimental Treatment1 Intervention
5 daily treatment sessions of MRI or CT-Guided Stereotactic Body Radiation Therapy (SBRT).
Hypofractionated External Beam Radiotherapy is already approved in United States, European Union, Canada, Japan for the following indications:
🇺🇸 Approved in United States as Hypofractionated External Beam Radiotherapy for:
- Endometrial cancer
- Cervical cancer
- Prostate cancer
- Breast cancer
- Lung cancer
🇪🇺 Approved in European Union as Hypofractionated Radiation Therapy for:
- Endometrial cancer
- Cervical cancer
- Prostate cancer
- Breast cancer
- Lung cancer
🇨🇦 Approved in Canada as Stereotactic Body Radiation Therapy (SBRT) for:
- Prostate cancer
- Lung cancer
- Liver cancer
- Spine tumors
🇯🇵 Approved in Japan as Hypofractionation for:
- Prostate cancer
- Breast cancer
- Lung cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California at Los AngelesLos Angeles, CA
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Who Is Running the Clinical Trial?
Jonsson Comprehensive Cancer CenterLead Sponsor
References
A Phase II Trial of Stereotactic Ablative Radiation Therapy as a Boost for Locally Advanced Cervical Cancer. [2020]Our purpose was to assess the feasibility, safety, and efficacy of stereotactic ablative radiation therapy (SAbR) as an alternative for intracavitary/interstitial brachytherapy boost for locally advanced cervical cancer (LACC) after initial chemoradiation.
Stereotactic body radiation therapy via helical tomotherapy to replace brachytherapy for brachytherapy-unsuitable cervical cancer patients - a preliminary result. [2022]To review the experience and to evaluate the results of stereotactic body radiation therapy (SBRT) via helical tomotherapy (HT), for the treatment of brachytherapy-unsuitable cervical cancer.
Moving from standardized to personalized boxes and pears in radiation planning for cervical cancer. [2015]We reviewed the most recent literature on advancements in external beam radiation therapy, brachytherapy, and stereotactic body radiation therapy (SBRT) in the treatment of cervical cancer.
Stereotactic ablative body radiotherapy boost for cervical cancer when brachytherapy boost is not feasible. [2022]The purpose of this study was to analyze the treatment efficacy and safety of stereotactic ablative body radiotherapy (SABR) boost for cervical cancer patients not amenable to brachytherapy.
Pelvic re-irradiation using stereotactic ablative radiotherapy (SABR): A systematic review. [2023]To perform a systematic review regarding the use of stereotactic ablative radiotherapy (SABR) for the re-irradiation of recurrent malignant disease within the pelvis, to guide the clinical implementation of this technique.
Stereotactic body radiation therapy for early-stage primary lung cancer, is an active breath coordinator necessary? An audit from a tertiary cancer care center. [2018]The hypofractionated stereotactic body radiation therapy (SBRT) has emerged as a safe and effective treatment modality for early-stage nonsmall cell lung carcinoma.
Long-term outcomes from a prospective trial of stereotactic body radiotherapy for low-risk prostate cancer. [2022]Hypofractionated radiotherapy has an intrinsically different normal tissue and tumor radiobiology. The results of a prospective trial of stereotactic body radiotherapy (SBRT) for prostate cancer with long-term patient-reported toxicity and tumor control rates are presented.
Short communication: timeline of radiation-induced kidney function loss after stereotactic ablative body radiotherapy of renal cell carcinoma as evaluated by serial (99m)Tc-DMSA SPECT/CT. [2022]Stereotactic ablative body radiotherapy (SABR) has been proposed as a definitive treatment for patients with inoperable primary renal cell carcinoma. However, there is little documentation detailing the radiobiological effects of hypofractionated radiation on healthy renal tissue.
Stereotactic body radiotherapy for low-risk prostate cancer: five-year outcomes. [2022]Hypofractionated, stereotactic body radiotherapy (SBRT) is an emerging treatment approach for prostate cancer. We present the outcomes for low-risk prostate cancer patients with a median follow-up of 5 years after SBRT.
Should helical tomotherapy replace brachytherapy for cervical cancer? Case report. [2022]Stereotactic body radiation therapy (SBRT) administered via a helical tomotherapy (HT) system is an effective modality for treating lung cancer and metastatic liver tumors. Whether SBRT delivered via HT is a feasible alternative to brachytherapy in treatment of locally advanced cervical cancer in patients with unusual anatomic configurations of the uterus has never been studied.
Determining the recommended dose of stereotactic body radiotherapy boost in patients with cervical cancer who are unsuitable for intracavitary brachytherapy: a phase I dose-escalation study. [2020]Some patients are ineligible for intracavitary brachytherapy (ICBT) for locally advanced cervical cancer. Stereotactic body radiotherapy (SBRT) could be a good treatment option for such patients. This phase I clinical trial aimed to determine the recommended SBRT boost dose for ICBT-ineligible cervical cancer patients.