CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 28 enrolled
Drug / intervention
Extraperitoneal laparoscopic lymphadenectomy (EPLND) +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01365156
NCT01365156Phase 3Completed
CompareCT.gov

A Phase III Randomized Study of Pretherapeutic Para-aortic Lymphadenectomy in Women With Locally Advanced Cervical Cancer Dispositioned to Definitive Chemoradiotherapy

M.D. Anderson Cancer Center·interventional·Posted Jun 3, 2011·Updated Feb 3, 2021

In Brief

A Phase 3 clinical trial evaluating Extraperitoneal laparoscopic lymphadenectomy (EPLND) and Chemoradiation for Cervical Squamous Cell Carcinoma and 4 related conditions. Completed, enrolled 28 participants across 3 sites in 2 countries.

Detailed Summary

The goal of this clinical research study is to learn if a surgical procedure called an extraperitoneal laparoscopic lymphadenectomy followed by chemotherapy and tailored radiation therapy can help to control the disease for a longer time than standard-of-care chemotherapy and whole pelvic radiation therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Squamous Cell Carcinoma, Adenosquamous Carcinoma, Adenocarcinoma, Locally Advanced Malignant Neoplasm, Cervical Cancer
CountriesBelgium, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 3, 2011
Enrollment StartAug 1, 2011
Primary CompletionJan 24, 2020
TodayJul 2, 2026
Enrollment to primary: 8.5 yearsPosted 15.1 years ago

Interventions

Extraperitoneal laparoscopic lymphadenectomy (EPLND)procedure

Laparoscopic surgical procedure to remove and examine lymph nodes in abdomen, 7-10 days before chemoradiation treatment

Chemoradiationradiation

Radiation for 5 days in a row for 5 to 5½ weeks plus Cisplatin Chemotherapy cisplatin chemotherapy by vein over about 2 hours, 1 time every week for about 6 weeks.