Tailored Therapy for Endometrial Cancer
Recruiting in Palo Alto (17 mi)
+39 other locations
Overseen ByMatthew Powell
Age: 18+
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: NRG Oncology
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This phase II trial tests how well tailoring therapy in post-surgery works in patients with low-risk endometrial cancer. The usual approach for patients with low-risk endometrial cancer is treatment with surgery. In this study, tissue that is removed as part of the surgical procedure is analyzed in the pathology laboratory to help guide the doctor to decide whether or not additional treatment such as radiation and or chemotherapy should be recommended.
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.
How does the tailored therapy for endometrial cancer differ from other treatments?
The tailored therapy for endometrial cancer is unique because it involves personalized treatment plans that may include brachytherapy (a type of internal radiation therapy) alone or in combination with external radiation, depending on individual risk factors. This approach is different from standard treatments that often rely on surgery followed by a one-size-fits-all radiation therapy.
1891011Is radiation therapy safe for treating endometrial cancer?
Radiation therapy, including external beam radiation therapy (EBRT) and brachytherapy, is generally considered safe for treating endometrial cancer, though it may cause some side effects. Studies have shown that these treatments are feasible and can be used effectively, especially in patients who cannot undergo surgery.
24569What data supports the effectiveness of the treatment for endometrial cancer?
Research shows that using external beam radiation therapy (EBRT) and brachytherapy together can effectively control endometrial cancer, especially in cases where surgery isn't an option. Studies indicate that these treatments can achieve high local control rates, meaning they are good at keeping the cancer from growing back in the treated area.
347910Eligibility Criteria
This trial is for adults over 18 with stage I to III endometrial carcinoma who've had surgery with no remaining visible disease. They must be able to complete questionnaires in English, French or another validated language and live close enough to the treatment center for follow-up. Those unwilling to fill out questionnaires or unable to return for follow-ups are excluded.Inclusion Criteria
My endometrial cancer is confirmed and is stage I to III.
I can care for myself and am up and about more than 50% of my waking hours.
I am 18 years old or older.
I had a hysterectomy and both ovaries removed with no visible cancer left.
Participant Groups
The study tests tailored therapy post-surgery in low-risk endometrial cancer patients. It involves analyzing surgically removed tissue to decide if additional treatments like radiation or chemotherapy are needed after surgery.
3Treatment groups
Experimental Treatment
Active Control
Group I: Cohort A2Experimental Treatment8 Interventions
Patients with higher-risk POLE-mutated EC undergo observation or EBRT and/or vaginal brachytherapy over 3-5 fractions. Patients undergo chest x-ray and CT or MRI or PET/CT scans during screening and as clinically indicated throughout the trial.
Group II: Sub-study BActive Control7 Interventions
Patients with p53 wildtype/NSMP ER+ EC undergo observation or vaginal brachytherapy over 3-5 fractions. Patients undergo chest x-ray and CT or MRI or PET/CT scans during screening and as clinically indicated throughout the trial.
Group III: Cohort A1Active Control6 Interventions
Patients with POLE-mutated early-stage EC undergo observation on study. Patients undergo chest x-ray and CT or MRI or PET/CT scans during screening and as clinically indicated throughout the trial.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Women and Infants HospitalProvidence, RI
UCHealth University of Colorado HospitalAurora, CO
Banner University Medical Center - TucsonTucson, AZ
Cedars Sinai Medical CenterLos Angeles, CA
More Trial Locations
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Who is running the clinical trial?
NRG OncologyLead Sponsor
Canadian Cancer Trials GroupCollaborator
National Cancer Institute (NCI)Collaborator
Canadian Cancer Trials Group (CCTG)Collaborator
References
Gynecologic brachytherapy-II: Intravaginal brachytherapy for carcinoma of the endometrium. [2004]Brachytherapy plays a significant role in the management of endometrial cancer. In the adjuvant setting, based on pathologic risk factors, intravaginal brachytherapy alone, external radiation therapy alone, or a combination of the two is recommended. For patients who are medically inoperable, brachytherapy with or without external beam therapy is the mainstay of treatment. In recurrent disease, to achieve improved local regional control interstitial and/or intravaginal brachytherapy is used as a boost. This article will highlight the indications and technical aspects of postoperative intravaginal brachytherapy, which is the most common application of brachytherapy in endometrial cancer.
External radiation therapy for endometrial carcinoma: the University Hospital of Ioannina experience. [2020]The aim of our study was to present the experience of our department in the treatment of endometrial cancer with postoperative external beam radiotherapy (EBRT) without intracavitary brachytherapy (BRT) and to evaluate the efficacy of such a method.
Survival and recurrent disease after postoperative radiotherapy for early endometrial cancer: systematic review and meta-analysis. [2022]To clarify the effect of postoperative (adjuvant) external-beam pelvic radiotherapy (EBRT) for different grades of early endometrial cancer.
Definitive radiation therapy for endometrial cancer in medically inoperable elderly patients. [2010]With the increasing elderly population, more women with newly diagnosed endometrial cancer may not be surgical candidates due to medical comorbidities. Definitive radiation therapy with external beam radiation (EBRT) and/or brachytherapy is a reasonable primary treatment for endometrial cancer in patients who cannot undergo surgery.
Use of electronic brachytherapy to deliver postsurgical adjuvant radiation therapy for endometrial cancer: a retrospective multicenter study. [2021]This retrospective, multicenter study evaluated the feasibility and safety of high-dose rate electronic brachytherapy (EBT) as a postsurgical adjuvant radiation therapy for endometrial cancer.
Adjuvant radiotherapy for endometrial cancer--a comparative review of radiotherapy technique with acute toxicity. [2020]The addition of pelvic radiotherapy to brachytherapy (EBRT-BT) in early-stage endometrial cancer is controversial and may cause unnecessary toxicity. The incidence of acute toxicity of EBRT-BT will have an impact on clinical decision and patient compliance but is currently poorly understood. This study compares the acute toxicities of EBRT-BT versus BT alone.
Image-guided high-dose-rate brachytherapy in inoperable endometrial cancer. [2022]Inoperable endometrial cancer may be treated with curative aim using radical radiotherapy alone. The radiation techniques are external beam radiotherapy (EBRT) alone, EBRT plus brachytherapy and brachytherapy alone. Recently, high-dose-rate brachytherapy has been used instead of low-dose-rate brachytherapy. Image-guided brachytherapy enables sufficient coverage of tumour and reduction of dose to the organs at risk, thus increasing the therapeutic ratio of treatment. Local control rates with three-dimensional brachytherapy appear better than with conventional techniques (about 90-100% and 70-90%, respectively).
The role of radiation therapy in the treatment of Stage II endometrial cancer: A large database study. [2019]The optimum adjuvant treatment for Stage II endometrial cancer patients is unknown. External beam radiation therapy (EBRT) is often considered the standard of care; however, retrospective series suggest that brachytherapy (BT) alone may be sufficient for selected patients. As randomized data are lacking, we used a large database to explore this question.
Combined external beam radiotherapy and vaginal brachytherapy versus vaginal brachytherapy in stage I, intermediate- and high-risk cases of endometrium carcinoma. [2022]Randomized trials on the effect of external beam radiotherapy (EBRT) with or without vaginal brachytherapy (VBT) for endometrial carcinoma are very few. In view of this, the current study was conducted with the hypothesizes: whether the escalated dose of 26 Gy (VBT alone) in comparison with various major international trials (PORTEC-2) has any difference in rates of disease-free and overall survival with fewer adverse effects in low resource setting like India.
Radiotherapy practices in postoperative endometrial cancer: A survey of the ABS membership. [2020]This survey aimed to document the current practice patterns of postoperative radiotherapy (RT), including vaginal vault brachytherapy (VVB) and external beam radiotherapy (EBRT), in the management of patients with endometrial cancer.
External beam management of stage I and II uterine cancer. [2022]This review article highlights the treatment paradigms for early-stage endometrial cancer with a focus on the role of external beam radiation therapy. We aim for this review to serve as an introductory resource for gynecological oncologists, radiation oncologists, medical oncologists, and other practitioners to understand the treatments for this disease. The main treatment of endometrial cancer is surgical resection with total hysterectomy and bilateral salpingo-oophorectomy. The benefit of adjuvant radiation after surgery is primarily to prevent local recurrence. Patients with low risk of recurrence can be observed post-operatively. Vaginal cuff brachytherapy, which has been shown to be equally effective as pelvic radiation with fewer side effects, is typically recommended for high-intermediate risk patients (with characteristics such as lymphovascular space invasion, high grade, or significant myometrial invasion). In the adjuvant setting, pelvic radiation therapy is reserved for patients who have deeply invasive stage I grade 2 or 3 disease, stage II disease, and non-endometrioid histologies. In patients who are not medically operable, definitive treatment consists of brachytherapy±pelvic external beam radiation therapy. We have highlighted the main acute and long-term side effects of pelvic radiation as well as recommendations for symptom management and summarized promising evidence showing improved rates of toxicities with more conformal radiation techniques.