Radiation Therapy + Cisplatin for Endometrial Cancer

Not currently recruiting at 453 trial locations

Age: Any Age

Sex: Female

Trial Phase: Phase 2

Sponsor: GOG Foundation

Disqualifiers: Extrapelvic disease, Prior irradiation, Severe infection, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether combining radiation therapy with the chemotherapy drug cisplatin is more effective than radiation therapy alone for treating recurrent endometrial cancer. Radiation therapy uses high-energy rays to kill cancer cells, while cisplatin stops cancer cells from growing and spreading. The study targets individuals whose endometrial cancer has returned in the pelvic area after a complete hysterectomy, with no signs of spreading outside the pelvis. Participants must have completed any previous hormone or chemotherapy treatments at least six months prior. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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. However, it mentions that any prior hormone therapy or chemotherapy must have been completed at least 6 months before joining the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that using cisplatin with radiation therapy is common in cancer treatments. One study found that 62.9% of patients experienced side effects after chemotherapy with cisplatin, but 96.4% of them survived for five years. This indicates that while side effects occur frequently, they can usually be managed.

For 3-Dimensional Conformal Radiation Therapy (3DCRT), research found that it can cause side effects, mainly stomach problems. About 19.2% of patients experienced significant stomach issues. However, doctors monitor this closely.

Intensity-Modulated Radiation Therapy (IMRT) tends to cause fewer stomach problems than 3DCRT, with only 11% of patients experiencing significant stomach issues.

Internal Radiation Therapy is often used when surgery isn't possible and is considered safe and effective. It has shown excellent results in treating endometrial cancer.

Overall, the treatments in this trial have been studied and are generally safe, though some side effects are expected and monitored. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of radiation therapy and cisplatin for endometrial cancer because it adds a chemotherapy component to enhance the effects of radiation. While standard treatments often involve surgery and radiation alone, this approach integrates cisplatin, a powerful chemotherapy drug, which is administered intravenously alongside targeted radiation. This combination has the potential to improve cancer cell destruction by making them more sensitive to radiation, possibly leading to better outcomes for patients. Additionally, the use of advanced radiation techniques, like Intensity-Modulated Radiation Therapy and brachytherapy, allows for more precise targeting of cancer cells while sparing healthy tissues.

What evidence suggests that this trial's treatments could be effective for endometrial cancer?

This trial will compare two treatment approaches for endometrial cancer. Research has shown that radiation therapy, such as 3-Dimensional Conformal Radiation Therapy (3DCRT), effectively treats endometrial cancer, with 82.3% of patients surviving for at least five years. Studies have found that this method also causes fewer bowel problems compared to other techniques. In this trial, one group of participants will receive radiation therapy alone, while another group will receive a combination of radiation therapy and cisplatin, a chemotherapy drug that stops cancer cells from growing and spreading. Although cisplatin might not significantly improve the time patients remain cancer-free in some cases, it is often used with radiation to better target cancer. Combining these treatments aims to improve overall effectiveness in treating recurrent endometrial cancer. ^{2 4 5 6 7}

Who Is on the Research Team?

Jonathan M Feddock

Principal Investigator

NRG Oncology

Are You a Good Fit for This Trial?

This trial is for patients with recurrent endometrial cancer who've had a hysterectomy and bilateral salpingo-oophorectomy. They should be in good physical condition (GOG status 0-2), have no extrapelvic disease, and could have had prior hormone or chemotherapy finished at least 6 months ago. Excluded are those with other recent cancers, severe heart conditions, previous pelvic radiation, or significant infections.

Inclusion Criteria

My nerve damage does not significantly affect my daily activities.

I have had a stent or tube placed for my blocked ureter before joining the study.

I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

I have not had serious heart problems in the last 6 months.

I have a severe infection or septicemia.

I have not had any cancer other than non-melanoma skin cancer in the past 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo external-beam radiotherapy (EBRT) to the pelvis daily for 5 weeks. In Arm II, participants also receive cisplatin intravenously on specified days.

5 weeks

Daily visits for EBRT, additional visits for cisplatin administration

Brachytherapy

Participants undergo intracavitary or interstitial brachytherapy following EBRT. IMRT boost is allowed for certain patients.

Following EBRT

Follow-up

Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs every month for 3 months, then every 3 months for 2 years, and every 6 months for 3 years.

5 years

What Are the Treatments Tested in This Trial?

Interventions

• 3-Dimensional Conformal Radiation Therapy
• Cisplatin
• Intensity-Modulated Radiation Therapy
• Internal Radiation Therapy

Trial Overview The study compares the effectiveness of radiation therapy alone versus combined with cisplatin in treating recurrent endometrial cancer. It's a phase II trial to see if adding cisplatin improves outcomes. Participants will receive either high-energy x-rays or both x-rays and cisplatin.

How Is the Trial Designed?

Group I: Arm II (brachytherapy, radiation therapy, cisplatin) Experimental Treatment 4 Interventions

Patients undergo EBRT as in Arm I and receive cisplatin IV over 1-2 hours on days 1, 8, 15, 22, and 29. Patients then undergo brachytherapy as in Arm I.

Group II: Arm I (brachytherapy, radiation therapy) Experimental Treatment 3 Interventions

Patients undergo EBRT to the pelvis daily on days 1-5 for 5 weeks. After completion of EBRT, patients undergo intracavitary low-dose rate or high-dose rate brachytherapy or low-dose rate interstitial brachytherapy.

3-Dimensional Conformal Radiation Therapy is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:

Approved in United States as 3D-CRT for:

• Various types of cancer, including gynecologic cancers

Approved in European Union as 3D-CRT for:

• Various types of cancer, including gynecologic cancers

Approved in Canada as 3D-CRT for:

• Various types of cancer, including gynecologic cancers

Approved in Japan as 3D-CRT for:

• Various types of cancer, including gynecologic cancers

Approved in China as 3D-CRT for:

• Various types of cancer, including gynecologic cancers

Approved in Switzerland as 3D-CRT for:

• Various types of cancer, including gynecologic cancers

Who Is Running the Clinical Trial?

GOG Foundation

Lead Sponsor

Trials

48

Recruited

18,500+

Gynecologic Oncology Group

Lead Sponsor

Trials

251

Recruited

65,400+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25562668/

Toxicity and cost-effectiveness analysis of intensity ... Conclusion: IMRT is associated with reduced late overall toxicity compared to 3DCRT without compromising clinical outcome. IMRT is not cost-effective during the ...

2. tandfonline.com tandfonline.com/doi/full/10.1080/0284186X.2021.1926537

Outcome and safety analysis of endometrial cancer ... We found that IMRT-treated EC patients showed comparable clinical outcomes but with a lower incidence of GI toxicities compared with those treated with 3DCRT.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0360301621028467

Radiation Therapy Techniques and Treatment-Related ... The results of the RTOG 1203 trial, which randomized women with endometrial or cervical cancer to either 3DCRT versus IMRT, showed significantly fewer bowel ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3808715/

A Population-Based Study - PMC - PubMed Central The 5-year survival rate in the 2DRT and 3DCRT groups was 73.0% and 82.3%, P = 0.007, respectively. Cervical cancer patients treated with 3DCRT had better ...

5. practicalradonc.org practicalradonc.org/article/S1879-8500(22)00273-9/fulltext

Radiation Therapy for Endometrial Cancer: An American ... In general, a 200 cGy equivalent dose of 5500 to 6500 cGy should be considered for gross nodes based on size, location, and dose per fraction ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33999750/

Outcome and safety analysis of endometrial cancer ... Acute grade ≥2 GI toxicity was significantly less in patients treated with IMRT compared to those treated with 3DCRT (11.0% vs. 19.2%, p=.004).

7. medicaljournalssweden.se medicaljournalssweden.se/actaoncologica/article/view/23928/27958

View of Outcome and safety analysis of endometrial cancer ... ResultsPatient characteristicsOf the 646 patients analyzed, 381 patients (59%) weretreated with IMRT and 265 patients (41%) were treated with3DCRT. The tumor ...