Hypofractionated Radiotherapy for Endometrial Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Christina Son, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: University of Chicago

Must not be taking: Chemotherapy

Disqualifiers: Metastases, Gross residual disease, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study will investigate if a shorter treatment course (known as "hypofractionation") for pelvic radiation is safe for women with endometrial cancer. Doctors leading the study will also determine the safest and most tolerable dose of shortened radiation (hypofractionation) used to treat women in this study. Because this study will shorten the radiation course typically used to treat endometrial cancer, each daily treatment given to women in this study will be slightly higher than normal to ensure that the total radiation dose they receive is still effective and similar to the radiation dose they would receive if they were not participating in this study (standard treatment).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot have chemotherapy at the same time as the study. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Hypofractionated Radiotherapy for Endometrial Cancer?

Research shows that hypofractionated radiotherapy has been effective in providing symptom relief for various advanced pelvic cancers, including rectal and ovarian tumors, with acceptable side effects. Additionally, similar treatments have shown promise in improving outcomes for other cancers like prostate and lung cancer, suggesting potential benefits for endometrial cancer as well.

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Is hypofractionated radiotherapy generally safe for humans?

Hypofractionated radiotherapy has been studied for conditions like prostate and breast cancer, and it is generally considered safe, though it may cause some short-term side effects. Long-term safety data from large trials suggest it does not significantly increase late side effects compared to traditional methods.

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How is hypofractionated radiotherapy different from other treatments for endometrial cancer?

Hypofractionated radiotherapy for endometrial cancer involves giving fewer, larger doses of radiation over a shorter period, which can reduce the treatment burden for patients compared to traditional radiation schedules. This approach has been effective in other cancers, like breast cancer, and may offer similar benefits for endometrial cancer, although it hasn't been extensively studied in this specific condition yet.

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Eligibility Criteria

This trial is for women over 18 with Stage I-III endometrial cancer who've had a hysterectomy and show no signs of remaining cancer or distant metastases. It's not for those receiving concurrent chemotherapy, with bowel issues, prior pelvic radiation, unresolved chemo side effects, or connective tissue disorders.

Inclusion Criteria

My diagnosis is endometrial cancer with a specific cell type.

I am 18 years old or older.

I am advised to have pelvic radiotherapy alone, not with chemotherapy.

Exclusion Criteria

I have a history of bowel issues or connective tissue disorder needing ongoing treatment, or I've had pelvic radiation.

I am not currently undergoing any chemotherapy.

I still have cancer cells after surgery, confirmed by my doctor.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Hypofractionated Radiation Treatment (Dose-Finding Arm)

Participants receive hypofractionated whole pelvic radiation treatment for a shortened time period to establish a safe and tolerable dose.

3-5 weeks

Expansion Cohort (Efficacy Arm)

Participants test the efficacy of the established dose of hypofractionated radiation treatment.

3-5 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with routine clinical follow-up approximately 1 month following radiation, then at 3 months, and every 3 months for the next 2 years.

2 years

Routine clinical follow-up at 1 month, 3 months, and every 3 months thereafter

Participant Groups

The study tests if a shorter course of higher-dose pelvic radiation (hypofractionation) is safe and effective in treating endometrial cancer compared to the standard longer treatment. The goal is to find the best dose that's both tolerable and similar in effectiveness to conventional therapy.

Group I: Hypofractionated Radiation Treatment (Dose-Finding Arm) Experimental Treatment 1 Intervention

All study participants in this arm will receive hypofractionated whole pelvic radiation treatment for a shortened time period of 3-5 weeks. The goal of this arm is to establish a safe and tolerable dose of shortened (hypofractionated) pelvic radiation treatment for study participants. Once a safe and tolerable dose is established for this shortened form of radiation treatment, participants who meet criteria for the second phase of this study will participate in an expansion cohort that will explore the efficacy (how effective shortened/hypofractionated radiation treatment is for treating endometrial cancer).

Group II: Expansion Cohort (Efficacy Arm) Experimental Treatment 1 Intervention

Participants in this arm will test how effective hypofractionated/shortened whole radiation treatment is ("efficacy") at the dose established in the first phase of this study by following up with their doctors to report their current health status and symptoms during clinical visits. Participants will return for routine clinical follow-up approximately 1 month following radiation, then at 3 months following radiation, then every 3 months for the next 2 years following treatment.

Hypofractionated Radiation is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Hypofractionated Radiotherapy for:

• Endometrial cancer

🇪🇺 Approved in European Union as Hypofractionated Radiotherapy for:

• Endometrial cancer
• Cervical cancer

🇨🇦 Approved in Canada as Hypofractionated Radiotherapy for:

• Endometrial cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Illinois at Chicago (UIC) Chicago, IL

MD Anderson Cancer Center Houston, TX

Huntsman Cancer Institute Salt Lake City, UT

University of Chicago Chicago, IL

Who Is Running the Clinical Trial?

University of Chicago Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

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.

2. United States pubmed.ncbi.nlm.nih.gov

Quality-of-Life Outcomes and Toxic Effects Among Patients With Cancers of the Uterus Treated With Stereotactic Pelvic Adjuvant Radiation Therapy: The SPARTACUS Phase 1/2 Nonrandomized Controlled Trial. [2023] Adjuvant radiation plays an important role in reducing locoregional recurrence in patients with uterine cancer. Although hypofractionated radiotherapy may benefit health care systems and the global community while decreasing treatment burden for patients traveling for daily radiotherapy, it has not been studied prospectively nor in randomized trials for treatment of uterine cancers, and the associated toxic effects and patient quality of life are unknown.

3. United States pubmed.ncbi.nlm.nih.gov

Image guided hypofractionated 3-dimensional radiation therapy in patients with inoperable advanced stage non-small cell lung cancer. [2018] Hypofractionated radiation therapy (HypoRT) can potentially improve local control with a higher biological effect and shorter overall treatment time. Response, local control, toxicity rates, and survival rates were evaluated in patients affected by inoperable advanced stage non-small cell lung cancer (NSCLC) who received HypoRT.

4. Switzerland pubmed.ncbi.nlm.nih.gov

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.

5. United States pubmed.ncbi.nlm.nih.gov

A review of hypofractionated palliative radiotherapy. [2022] Radiotherapy commonly is employed to address symptoms in patients with symptoms caused by cancer. For this article, the authors reviewed data supporting the use of hypofractionated palliative radiotherapy. In addition to single-fraction treatment for painful bony metastasis, the available literature suggested that courses of 2 to 14 external-beam fractions may provide equivalent relief to longer course treatment in patients with a poor prognosis who have primary cancers of the lung, rectum, bladder, prostate, head and neck, spleen, and gynecologic system. Hypofractionated treatment delivers palliation that is time efficient, cost effective, and minimally toxic. Evidence suggests that the reluctance of radiation oncologists to provide single-fraction treatment acts as a barrier to referrals from palliative care professionals. Collaboration in education, research, and patient advocacy will advance the common objectives of the 2 specialties and lead to an appropriate increase in the use of palliative hypofractionated radiotherapy.

6. England pubmed.ncbi.nlm.nih.gov

Hypofractionation for prostate cancer: an update. [2019] Recent advances in image guided radiation therapy (IGRT) has prompted much interest in the use of high-dose-per-fraction regimens for prostate cancer. Furthermore, from a radiobiological standpoint, there is increasing evidence that prostate tumors have a relatively low ɑ/β ratio therefore, the use of hypofractionation may potentially offer acceptable tumor control while minimizing late toxicity to critical structures. Areas covered: This expert review explores the current evidence regarding the safety and efficacy of hypofractionated radiotherapy for prostate cancer. A particular emphasis was placed on large, randomized phase III trials as these are most likely to influence clinical practice. The authors discuss the use of both moderate and extreme hypofractionation. Expert commentary: The recent publication of 5-year outcomes from large prospective trials of moderate hypofractionation enhances our confidence that these techniques are both safe and effective. We recommend the fractionation scheme of 60 Gy in 20 fractions as this regimen was not associated with any notable increase in late toxicity. With respect to extreme hypofractionation, mature phase III trials are needed to demonstrate the safety and efficacy of these techniques. For now, the use of radiosurgery should be limited to participation in prospective clinical trials.

7. Netherlands pubmed.ncbi.nlm.nih.gov

What are the minimal standards of radiotherapy planning and dosimetry for "hypofractionated" radiotherapy in breast cancer? [2018] Hypofractionated radiotherapy regimens have become increasingly popular in breast cancer, particularly in the UK and Canada. However, there are some potential problems inherent to providing such regimens, such as the concern of increased toxicity. In this article we discuss the planning and dosimetry and requirements for hypofractionated radiotherapy in breast cancer and make recommendations both for the planning process and for treatment monitoring.

8. Ireland pubmed.ncbi.nlm.nih.gov

Acute and late toxicity patterns of moderate hypo-fractionated radiotherapy for prostate cancer: A systematic review and meta-analysis. [2023] Moderate hypofractionated (HF) radiotherapy is becoming the new standard in radiotherapy for prostate cancer patients. It is established as safe, but it might be associated with increased acute toxicity levels. We conducted a systematic review on moderate HF to establish acute toxicity levels and their required clinical management; late toxicity was reported as a secondary outcome.

9. England pubmed.ncbi.nlm.nih.gov

Accelerated hypofractionated radiotherapy as adjuvant regimen after conserving surgery for early breast cancer: interim report of toxicity after a minimum follow up of 3 years. [2021] Accelerated hypofractionation is an attractive approach for adjuvant whole breast radiotherapy. In this study we evaluated the adverse effects at least 3 years post an accelerated hypofractionated whole breast radiotherapy schedule.

10. England pubmed.ncbi.nlm.nih.gov

Hypofractionated versus conventionally fractionated radiotherapy for patients with localised prostate cancer (HYPRO): final efficacy results from a randomised, multicentre, open-label, phase 3 trial. [2022] Studies have reported a low α/β ratio for prostate cancer, suggesting that hypofractionation could enhance the biological tumour dose without increasing genitourinary and gastrointestinal toxicity. In the multicentre phase 3, HYpofractionated irradiation for PROstate cancer (HYPRO) trial, hypofractionated radiotherapy was compared with conventionally fractionated radiotherapy for treatment of prostate cancer. We have previously reported acute and late incidence of genitourinary and gastrointestinal toxicity; here we report protocol-defined 5-year relapse-free survival outcomes.

11. India pubmed.ncbi.nlm.nih.gov

Hypofractionated radiotherapy in carcinoma cervix IIIB: Tata Memorial Hospital experience. [2018] To analyze the role of hypofractionated radiotherapy in advanced carcinoma of cervix.

12. United States pubmed.ncbi.nlm.nih.gov

Hypofractionated radiation therapy in the treatment of early-stage breast cancer. [2021] Hypofractionated radiation refers to the use of fewer, larger-dose radiation treatments that are usually given over a shorter time period compared to conventional radiation fraction sizes. Randomized trials of hypofractionated whole breast irradiation (WBI) have demonstrated comparable outcomes as conventional fractionation. For a higher-risk population for local recurrence, a phase 3 trial by the Radiation Therapy Oncology Group (RTOG) is currently studying hypofractionated WBI with a concurrent tumor bed boost over 3 weeks. Accelerated partial breast irradiation limits radiation to the region of the tumor bed for 1-3 weeks and is the subject of an ongoing randomized trial by the National Surgical Breast and Bowel Project and RTOG. Questions remain for hypofractionation about optimal patient selection, radiation techniques, and the risk of late toxicity. But results from current trials could make hypofractionation more widely accepted for patients with early-stage breast cancer.

13. United States pubmed.ncbi.nlm.nih.gov

Vaginal brachytherapy alone: an alternative to adjuvant whole pelvis radiation for early stage endometrial cancer. [2018] Postoperative management of early stage adenocarcinoma of the endometrium remains controversial. The use of pelvic radiation therapy as shown by the Gynecologic Oncology Group (GOG)-99 trial improves the event free interval at the cost of increased toxicity. We reviewed and compared our results treating early stage endometrial adenocarcinoma using hypofractionated high dose rate (HDR) vaginal brachytherapy (VB) alone with the results of the GOG-99.