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Radiation Therapy + Cisplatin for Endometrial Cancer

Phase 2

Waitlist Available

Led By Jonathan M Feddock

Research Sponsored by GOG Foundation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Neuropathy (sensory and motor) =< CTCAE v 3.0 grade 1

Patients with ureteral obstruction must undergo stent or nephrostomy tube placement prior to study entry

Must not have

Patients with septicemia or severe infection

Patients with evidence of disease outside of the pelvis, including presence of positive periaortic or inguino-femoral nodes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up median follow-up for progression-free survival was 62 months with a maximum of 128 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at how well radiation therapy and cisplatin work together or separately to treat endometrial cancer patients.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Radiation may cause fatigue, skin changes, and discomfort at the treatment site. Cisplatin can lead to nausea, kidney issues, hearing loss, nerve damage (neuropathy), and an increased risk of infection due to lowered blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My nerve damage does not significantly affect my daily activities.

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

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

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I have been diagnosed with a type of endometrial carcinoma.

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I have not had extensive surgery, but I am eligible if all visible cancer was removed.

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My endometrial cancer has returned in my pelvis or vagina, with no spread outside the pelvis.

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I had surgery to remove my uterus, ovaries, and fallopian tubes for uterine cancer.

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My cancer has not spread beyond the pelvic area.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a severe infection or septicemia.

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My cancer has spread outside the pelvis, including to lymph nodes.

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My condition limits me to only taking care of myself or I am completely disabled.

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I have a unique kidney shape or a kidney transplant affecting radiation treatment.

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I had surgery to remove a returning tumor and scans show no remaining cancer.

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I have received chemotherapy for my current cancer recurrence.

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I have had radiation therapy in the vaginal, pelvic, or abdominal area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ median follow-up for progression-free survival was 62 months with a maximum of 128 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~median follow-up for progression-free survival was 62 months with a maximum of 128 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and median follow-up for progression-free survival was 62 months with a maximum of 128 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Disease Progression or Death.

Secondary study objectives

Number of Participants That Experienced Adverse Effects Grade 3 or Higher

Number of Participants That Experienced Death on Study

Number of Participants in Select Prognostic Groups Who Experienced Progression or Death on Study.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (brachytherapy, radiation therapy, cisplatin)Experimental Treatment4 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 Treatment3 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Chloride ion

Not yet FDA approved

Internal Radiation Therapy

2006

Completed Phase 3

~290

3-Dimensional Conformal Radiation Therapy

2010