Arm 2 (sentinel lymph node mapping, pelvic lymphadenectomy) for Stage I Uterine Corpus Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Northwestern University, Chicago, ILStage I Uterine Corpus CancerMinimally Invasive Surgery - Procedure
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial compares sentinel lymph node mapping vs. standard lymph node dissection to reduce risk of leg swelling in patients undergoing hysterectomy for stage I endometrial cancer.

Eligible Conditions
  • Stage I Uterine Corpus Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: From enrollment and at 3, 6, 9, 12, and 18 months after surgery.

Month 39
Incidence of patient-reported lower extremity limb dysfunction
Month 18
The incidence of lymphedema by bioimpedance assessments (if available)
The incidence of lymphedema by quantifiable lower extremity limb changes

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Arm 2 (sentinel lymph node mapping, pelvic lymphadenectomy)
1 of 2
Arm 1 (sentinel lymph node mapping)
1 of 2

Experimental Treatment

428 Total Participants · 2 Treatment Groups

Primary Treatment: Arm 2 (sentinel lymph node mapping, pelvic lymphadenectomy) · No Placebo Group · Phase 3

Arm 2 (sentinel lymph node mapping, pelvic lymphadenectomy)Experimental Group · 5 Interventions: Minimally Invasive Surgery, Sentinel Lymph Node Mapping, Indocyanine Green Solution, Pelvic Lymphadenectomy, Questionnaire Administration · Intervention Types: Procedure, Procedure, Drug, Procedure, Other
Arm 1 (sentinel lymph node mapping)Experimental Group · 5 Interventions: Minimally Invasive Surgery, Sentinel Lymph Node Mapping, Indocyanine Green Solution, Pelvic Lymphadenectomy, Questionnaire Administration · Intervention Types: Procedure, Procedure, Drug, Procedure, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Minimally Invasive Surgery
2010
N/A
~70
Indocyanine Green Solution
2015
N/A
~110

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from enrollment and at 3, 6, 9, 12, and 18 months after surgery.

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,153 Previous Clinical Trials
41,162,496 Total Patients Enrolled
10 Trials studying Stage I Uterine Corpus Cancer
10,773 Patients Enrolled for Stage I Uterine Corpus Cancer
NRG OncologyLead Sponsor
219 Previous Clinical Trials
95,172 Total Patients Enrolled
Edward Tanner, MDPrincipal InvestigatorNRG Oncology

Eligibility Criteria

Age 18+ · Female Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have had a previous or current cancer that will not interfere with the safety or effectiveness of the treatment being studied.

Frequently Asked Questions

Are there any more opportunities for participants to join this clinical experiment?

"According to clinicaltrials.gov, this research endeavor is still enrolling participants. It was initially published on September 19th 2022 and underwent the latest revision on December 2nd 2022. The study necessitates 428 individuals at a solitary site for completion." - Anonymous Online Contributor

Unverified Answer

Has the sentinel lymph node mapping technique attained FDA approval?

"Our team evaluated the safety of Arm 1 (sentinel lymph node mapping) to be a 3 due to existing evidence from Phase 3 trials that suggest it is both efficacious and safe." - Anonymous Online Contributor

Unverified Answer

How many participants are recruited for this research?

"Affirmative. On clinicaltrials.gov, it is stated that this research project began recruitment on September 19th 2022 and was recently updated December 2nd of the same year. The aim is to gather 428 study participants from a single medical site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.