Sentinel Node Biopsy for Early Cervical Cancer
(SENTICOLIII Trial)

Recruiting in Palo Alto (17 mi)

+111 other locations

Overseen byFabrice Lecuru, MD PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Centre Hospitalier Universitaire de Besancon

No Placebo Group

Trial Summary

What is the purpose of this trial?SENTICOL III is large prospective multicenter international randomized study designed to validate the Sentinel Lymph Node (SLN) mapping technique in early cervical cancer. This "validation study" will compare the outcome of patients with negative SLN (experimental arm) vs patients with negative SLN + Pelvic Lymph Node dissection (PLN)(reference arm). There will be a "quality assurance" program which will be developed in participating centers with detailed requirements in terms of surgeons' qualifications, pathology qualification, SLN ultrastaging, standardization of the procedure, etc. as well as respect of the "safety algorithm".

Eligibility Criteria

This trial is for adults over 18 with early-stage cervical cancer (specific types like squamous, adenocarcinoma, or adenosquamous carcinoma). The tumor must be smaller than 40mm and not have spread to lymph nodes as seen on MRI. Participants need to be in good enough health to undergo surgery and agree to follow-up visits.

Inclusion Criteria

My cancer is at an early to mid-stage according to the 2018 FIGO classification.

My tumor is 40 mm or smaller according to a physical exam or MRI.

I am 18 years old or older.

+6 more

Exclusion Criteria

I have had chemotherapy or radiation for cervical cancer before.

I have more than one type of cancer at the same time.

I have had cancer in my pelvis or abdomen before.

+3 more

Participant Groups

The SENTICOL III study is testing if removing only the sentinel lymph node (SLN) in early cervical cancer patients is as effective as removing SLN plus additional pelvic lymph nodes. It's a large international study ensuring surgeons and pathologists follow strict guidelines for quality.

2Treatment groups

Experimental Treatment

Active Control

Group I: SLN biopsy onlyExperimental Treatment1 Intervention

Sentinel lymph node (SLN) biopsy only. A full lymphadenectomy will not be performed. The radical hysterectomy or trachelectomy will be done.

Group II: SLN biopsy + PLN dissectionActive Control1 Intervention

SLN biopsy + full pelvic lymph node dissection (PLN) will be performed. The radical hysterectomy or trachelectomy will be done.