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Alkylating agents

CarboTaxol + Radiotherapy for Endometrial Cancer

Phase 2

Waitlist Available

Led By Matthew Harkenrider, MD

Research Sponsored by Loyola University

Eligibility Criteria Checklist

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

Must have

ECOG Performance Status 0-2

Serous Carcinoma, Clear Cell Carcinoma, Carcinosarcoma Stage I-IIIC1, IVA

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial will test if a combination of chemotherapy, radiation, and drugs is safe for endometrial cancer. If safe, it would be tested for efficacy in a Phase III study.

Who is the study for?

This trial is for individuals with high-risk endometrial cancer who've had surgery. It's open to those with certain types of cancer cells, recommended for combined chemo and radiotherapy post-surgery, without prior pelvic radiation or evidence of spread beyond the pelvis. Participants must be able to perform daily activities with little to no assistance (ECOG 0-2) and give informed consent.

What is being tested?

The trial tests how safe it is to use Carboplatin and Paclitaxel chemotherapy in sequence or at the same time as external beam radiotherapy after surgery. The main focus is on severe side effects from this treatment combination. Initially, 11 patients will be tested; if too many experience serious side effects, the study may stop early.

What are the potential side effects?

Potential serious side effects include significant non-blood related toxicities like organ damage (grade 3-4), and severe blood-related issues (grade 4). These could lead to stopping the treatment if they occur frequently among participants.

Eligibility Criteria

Inclusion Criteria

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

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I can care for myself and am up and about more than 50% of my waking hours.

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My cancer is in stages I to IV and is one of the specified types.

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I have never had radiation therapy to my pelvic area.

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My doctor recommends both chemotherapy and radiation after reviewing my cancer.

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My cancer has not spread to lymph nodes or other parts of my body.

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I had surgery for endometrial cancer with a specific type of tumor.

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My endometrial cancer is at an early or specific advanced stage with high risk features.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Acute Toxicities (CTCAE v5.0)

Secondary study objectives

Chronic Toxicities (CTCAE v5.0)

Treatment Delays

cause-specific survival

+5 more

Awards & Highlights

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.

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Full Dose Chemo, Reduced Dose Chemo + RT, Full Dose ChemoExperimental Treatment2 Interventions

Week 1 : Cycle 1: Full Dose Carboplatin and Paclitaxel Week 4: Pelvic Radiotherapy Begins Cycle 2: Dose reduced Carboplatin and Paclitaxel Week 7 : Cycle 3: Dose reduced Carboplatin and Paclitaxel Weeks 10,13,16: Cycle 4-6: Full Dose Carboplatin and Paclitaxel

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 7Eligibility criteria met