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Chemotherapy

Radiation + Chemotherapy for Uterine Cancer

Phase 3

Waitlist Available

Led By Marcus E Randall

Research Sponsored by Gynecologic Oncology Group

Eligibility Criteria Checklist

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

Must have

Patients with stage II endometrial carcinoma (any histology) with cervical stromal invasion (occult or gross involvement), with or without high-intermediate risk factors

To be considered eligible to participate in this trial, all patients must have undergone hysterectomy; bilateral salpingo-oophorectomy (open or laparoscopic approach) is strongly encouraged

Must not have

Patients with pathologically confirmed spread of cancer beyond the uterus and cervix to pelvic or para-aortic lymph nodes, adnexal structures, and/or other anatomic sites, or patients with serous or clear cell histology and with positive cytologic washings

Patients who have received prior radiotherapy directed to treat disease within the abdominal cavity or pelvis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up overall survival is measured from study enrollment for up to 10 years.

Awards & highlights

No Placebo-Only Group

Pivotal Trial

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Summary

This trial is comparing different radiation therapies and chemotherapy drugs to see which is more effective in treating endometrial cancer.

Who is the study for?

This trial is for patients with high-risk stage I or II endometrial cancer who've had a hysterectomy and possibly other surgeries. They should be in good health, with no recent invasive cancers (except non-melanoma skin cancer), no prior treatments for endometrial cancer, and no evidence of disease spread beyond the uterus based on imaging.

What is being tested?

The study compares pelvic radiation therapy alone to vaginal implant radiation combined with chemotherapy drugs paclitaxel and carboplatin. It aims to determine which treatment is more effective at killing tumor cells without spreading them further.

What are the potential side effects?

Potential side effects include fatigue, nerve damage symptoms like numbness or tingling (neurotoxicity), digestive issues from chemotherapy, risks associated with radiation such as skin irritation or changes in bowel habits, and general discomfort from the procedures.

Eligibility Criteria

Inclusion Criteria

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

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My endometrial cancer is stage II with cervical invasion.

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I have had a hysterectomy, and removal of both ovaries is highly recommended.

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I am 18 or older and have 3 risk factors.

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My cancer is confined to the uterus and has a specific cell type, with no cancer cells found in my abdomen.

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

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My kidney function test shows I can clear more than 50 mL/min.

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My nerve damage does not significantly affect my daily activities.

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I am 70 or older with at least one risk factor or 50 or older with two risk factors.

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My cancer is a specific type of endometrial carcinoma and fits certain risk categories.

Exclusion Criteria

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

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My cancer has spread beyond my uterus and cervix.

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I have had radiation therapy for cancer in my abdomen or pelvis.

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I cannot receive radiation therapy to my pelvis due to health reasons.

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My endometrial cancer has come back.

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My cancer is a rare type of uterine cancer, not the common endometrial cancer.

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I have had non-surgical treatment for endometrial cancer.

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My endometrial cancer is at an advanced stage (III or IV).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ overall survival is measured from study enrollment for up to 10 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~overall survival is measured from study enrollment for up to 10 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and overall survival is measured from study enrollment for up to 10 years. 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 Recurrence or Death Events at Primary Analysis

Secondary study objectives

Number of Participants With Death Events

Number of Participants With Sites of Recurrence

Patient Reported Fatigue

+2 more

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (brachytherapy, paclitaxel, carboplatin)Experimental Treatment6 Interventions

Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (pelvic radiation therapy)Active Control6 Interventions

Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

FDA approved

Internal Radiation Therapy

2006

Completed Phase 3

~290

Paclitaxel

FDA approved