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Multimodality Treatment for Endometrial Cancer

Phase 2

Waitlist Available

Led By Mohamed Elshaikh, MD

Research Sponsored by Henry Ford Health System

Eligibility Criteria Checklist

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

Must have

candidates for combined modality treatment (surgery, chemotherapy with carbo/Taxol, and radiation therapy)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is studying a combination of chemotherapy and radiation therapy as a potential treatment for endometrial cancer.

Who is the study for?

This trial is for women with FIGO stage III uterine carcinoma who are candidates for combined treatment involving surgery, chemotherapy (with carboplatin and paclitaxel), and radiation therapy. Women not at this cancer stage, those with carcinosarcoma histology, or ineligible for such treatments cannot participate.Check my eligibility

What is being tested?

The study tests the quality of life in women receiving concurrent chemoRT using a carboplatin/paclitaxel-based regimen after surgery. It involves collecting data on survival rates and side effects while patients complete validated questionnaires over two years post-surgery.See study design

What are the potential side effects?

Patients may experience significant toxicities from the treatment including fatigue, nausea, potential nerve damage (neuropathy), as well as risks associated with radiation like skin irritation and more serious complications depending on individual health factors.

Eligibility Criteria

Inclusion Criteria

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

Select...

You are being considered for a combination of treatments that includes surgery, chemotherapy with carbo/Taxol, and radiation therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assessment of Physical and Functional Well-being as Assessed by the FACT-G Questionnaire

Assessment of Severity of GI Side Effects as Assessed by the FACT-C Questionnaire

Assessment of Severity of Neurotoxicity Side Effects as Assessed by the FACT/GOG-NTX-4 Scale

+1 more

Secondary outcome measures

Disease-Free Survival

Overall survival

Recurrence-Free Survival

Trial Design

1Treatment groups

Experimental Treatment

Group I: Quality of life evaluationExperimental Treatment1 Intervention

This prospective arm will consist of evaluating quality of life outcomes in women in women with advanced endometrial cancer undergoing adjuvant concurrent chemotherapy with carbo/Taxol and radiation therapy. Assessments will occur following surgery (baseline), 3, 6, 12, and 24 months.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor

300 Previous Clinical Trials

2,099,990 Total Patients Enrolled

Mohamed Elshaikh, MDPrincipal InvestigatorHenry Ford Health System

Andrew Cook, MDPrincipal Investigator - Physician

Henry Ford Health System

Media Library

Quality of life questionnaire Clinical Trial Eligibility Overview. Trial Name: NCT04743999 — Phase 2

Endometrial Cancer Research Study Groups: Quality of life evaluation

Endometrial Cancer Clinical Trial 2023: Quality of life questionnaire Highlights & Side Effects. Trial Name: NCT04743999 — Phase 2

Quality of life questionnaire 2023 Treatment Timeline for Medical Study. Trial Name: NCT04743999 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Quality of Life questionnaire been given official endorsement by the US Food and Drug Administration?

"Our team has gauged the Quality of Life questionnaire's safety as a 2, in accordance with its phase 2 status. This is because there are some data points that demonstrate safety but minimal to no evidence demonstrating efficacy."

Answered by AI

Is there an age limit for participating in this research endeavor?

"Adults aged 18 to 90 are eligible for this investigation, while separate clinical trials exist for minors (18 and under) and seniors (65+). Specifically, there are eighteen studies available to those younger than 18 years old and two hundred seventy-six open slots in research accessible by the elderly."

Answered by AI

Who would be a qualified candidate for this medical experiment?

"This clinical trial is seeking 60 individuals to participate in the study, between 18 and 90 years of age, who have been diagnosed with endometrial cancer."

Answered by AI

How many participants are being recruited for this trial?

"Affirmative. The clinical trial, which was first published on February 27th 2020 is still recruiting participants as per the latest information provided by clinicaltrials.gov. A total of 60 patients must be enrolled at a single site for this study to proceed with its objectives."

Answered by AI

Are there still vacancies in this experiment?

"According to the clinicaltrials.gov portal, this research is currently enrolling participants with a study start date of February 27th 2020 and an update on February 22nd 2022."

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

Adjuvant Chemotherapy Plus Radiation for Locally Advanced Endometrial Cancer

Matei, Daniela, Virginia Filiaci, Marcus E. Randall, David Mutch, Margaret M. Steinhoff, Paul A. DiSilvestro, Katherine M. Moxley, et al.. 2019. “Adjuvant Chemotherapy Plus Radiation for Locally Advanced Endometrial Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1813181.

Gynecologic OncologyJournal

Concomitant Chemotherapy and Radiation for the Treatment of Advanced-stage Endometrial Cancer

Wilkinson-Ryan, I., P.S. Binder, S. Pourabolghasem, N. Al-Hammadi, K. Fuh, A. Hagemann, P. Thaker, et al.. 2014. “Concomitant Chemotherapy and Radiation for the Treatment of Advanced-stage Endometrial Cancer”. Gynecologic Oncology. Elsevier BV. doi:10.1016/j.ygyno.2014.05.002.

The Lancet OncologyJournal

Adjuvant Chemoradiotherapy Versus Radiotherapy Alone for Women with High-risk Endometrial Cancer (PORTEC-3): Final Results of an International, Open-label, Multicentre, Randomised, Phase 3 Trial

de Boer, Stephanie M, Melanie E Powell, Linda Mileshkin, Dionyssios Katsaros, Paul Bessette, Christine Haie-Meder, Petronella B Ottevanger, et al.. 2018. “Adjuvant Chemoradiotherapy Versus Radiotherapy Alone for Women with High-risk Endometrial Cancer (PORTEC-3): Final Results of an International, Open-label, Multicentre, Randomised, Phase 3 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(18)30079-2.

Journal of Clinical OncologyJournal