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Alkylating agents

Chemotherapy + Radiation for Uterine Cancer

Phase 3

Waitlist Available

Led By Daniela E Matei

Research Sponsored by Gynecologic Oncology Group

Eligibility Criteria Checklist

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

Must have

All patients with surgical stage III or IVA endometrial carcinoma per FIGO 2009 staging criteria including clear cell and serous papillary and undifferentiated carcinoma

Surgical stage IVA patients with bladder or bowel mucosal involvement, but no spread outside the pelvis

Must not have

Patients with carcinosarcoma

Patients with recurrent endometrial cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from entry into the study to death or the date of last contact, assessed up to 8 years

Awards & highlights

Approved for 10 Other Conditions

No Placebo-Only Group

Pivotal Trial

Summary

This trial is comparing the effectiveness of two chemotherapy drugs, either with or without a third drug and radiation therapy, in treating endometrial cancer.

Who is the study for?

This trial is for patients with stage I-IVA endometrial cancer who've had surgery including hysterectomy and possibly lymph node sampling. They must have certain blood cell counts, liver function within normal limits, no prior pelvic/abdominal radiation or chemotherapy for endometrial cancer, no other active cancers in the last five years (except non-melanoma skin cancer), and not exceed a tumor size of 2 cm after surgery.

What is being tested?

The study compares carboplatin and paclitaxel chemotherapy with or without additional cisplatin and radiation therapy to see which is more effective at treating endometrial cancer post-surgery. The goal is to determine if adding cisplatin and radiation improves outcomes.

What are the potential side effects?

Chemotherapy drugs like carboplatin, paclitaxel, and cisplatin can cause side effects such as nausea, fatigue, hair loss, nerve damage leading to numbness or tingling sensations. Radiation therapy may result in skin irritation at the treatment site, fatigue, upset stomach.

Eligibility Criteria

Inclusion Criteria

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

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My endometrial cancer is at stage III or IVA.

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My cancer is stage IVA, affecting my bladder or bowel but hasn't spread beyond my pelvis.

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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 cancer is at a surgical stage III with specific complications.

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I have early-stage endometrial cancer with specific cell types and positive peritoneal cytology.

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I had surgery less than 8 weeks ago.

Exclusion Criteria

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

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I have been diagnosed with carcinosarcoma.

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My endometrial cancer has come back.

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I have a tumor larger than 2 cm remaining after surgery.

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I have had radiation therapy in my pelvic or abdominal area.

Select...

I have had chemotherapy for endometrial cancer before.

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My only extra-uterine cancer is not clear cell or papillary serous.

Select...

My cancer has spread to the liver.

Select...

My condition is stage IVB endometrial cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from entry into the study to death or the date of last contact, assessed up to 8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from entry into the study to death or the date of last contact, assessed up to 8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from entry into the study to death or the date of last contact, assessed up to 8 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, Progression or Death

Secondary study objectives

Number of Participants With Acute Adverse Effects as Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version (CTCAE) Version 3.0

Number of Participants With Late Adverse Events as Graded by the NCI CTCAE Version 3.0

Overall Survival

+2 more

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

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.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (cisplatin, radiation therapy, paclitaxel, carboplatin)Experimental Treatment6 Interventions

Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (paclitaxel and carboplatin)Active Control3 Interventions

Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

FDA approved

Radiation Therapy

2017

Completed Phase 3

~7250

Carboplatin

FDA approved