Sentinel Node Biopsy for Early Cervical Cancer

(SENTICOLIII Trial)

Not currently recruiting at 121 trial locations

Overseen By Sixtine Genel

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Centre Hospitalier Universitaire de Besancon

Disqualifiers: Pregnancy, Previous cancer, Allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Surgical procedure duration

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to determine if cervical cancer has spread to the lymph nodes. One group will undergo only the sentinel lymph node biopsy (SLN biopsy), while the other will have the biopsy plus a full pelvic lymph node removal (PLN dissection). The goal is to identify the best method for early-stage cervical cancer. Women with a confirmed diagnosis of specific types of early cervical cancer, who show no suspicious lymph nodes on MRI, might be suitable candidates for this trial. As an unphased trial, this study provides an opportunity to contribute to important research that could enhance future cervical cancer treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the SLN mapping technique is safe for early cervical cancer?

Research has shown that a sentinel lymph node (SLN) biopsy, when used alone for early cervical cancer, is generally safe and well-tolerated. Studies indicate that over 90% of patients experience high survival rates after just the SLN biopsy, with very few serious side effects.

When combined with pelvic lymph node (PLN) dissection, the safety remains similar. Notably, survival rates are comparable to more traditional methods, indicating that both approaches are safe for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores less invasive techniques for early cervical cancer surgery. Unlike the standard of care, which typically involves a full pelvic lymph node dissection, this trial examines the effectiveness of a sentinel lymph node (SLN) biopsy alone. This approach could potentially reduce surgical complications and recovery time. Additionally, the trial compares SLN biopsy alone with the combination of SLN biopsy plus full pelvic lymph node dissection, aiming to determine if the less invasive method can provide similar cancer control. The hope is to find a balance that offers patients effective treatment with fewer side effects.

What evidence suggests that this trial's treatments could be effective for early cervical cancer?

This trial will compare two approaches for early-stage cervical cancer: SLN biopsy only and SLN biopsy combined with pelvic lymph node (PLN) dissection. Research has shown that a sentinel lymph node (SLN) biopsy alone can be effective for early-stage cervical cancer. Studies indicate that more than 90% of patients remain cancer-free and survive for at least five years after just an SLN biopsy. One study found that 96.8% of patients were cancer-free after three years with SLN biopsy, compared to 94.5% with more extensive surgery. This suggests that SLN biopsy alone offers similar protection against cancer recurrence as the more invasive surgery that includes pelvic lymph node removal.

Research also supports combining SLN biopsy with pelvic lymph node (PLN) removal. This method effectively detects cancer spread and is cost-efficient when performed during a hysterectomy for cervical cancer. However, studies show that most patients do not have cancer in their lymph nodes, so the additional surgery might not always be necessary. Both methods are being evaluated in this trial as promising options for treating early cervical cancer. ^{1 3 6 7 8}

Who Is on the Research Team?

Fabrice Lecuru, MD PhD

Principal Investigator

Institut Curie

Are You a Good Fit for This Trial?

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.

My cervical cancer diagnosis was confirmed by a biopsy.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Sentinel Lymph Node (SLN) biopsy with or without Pelvic Lymph Node (PLN) dissection

Surgical procedure duration

Follow-up

Participants are monitored for health-related quality of life and disease-free survival

3 years

What Are the Treatments Tested in This Trial?

Interventions

• SLN biopsy only
• SLN biopsy + PLN dissection

Trial Overview

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.

How Is the Trial Designed?

Group I: SLN biopsy only Experimental Treatment 1 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 dissection Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Centre Hospitalier Universitaire de Besancon

Lead Sponsor

Trials

470

Recruited

827,000+

ARCAGY/ GINECO GROUP

Collaborator

Trials

65

Recruited

16,600+

European Network of Gynaecological Oncological Trial Groups (ENGOT)

Collaborator

Trials

41

Recruited

19,200+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12414009/

Sentinel lymph node biopsy versus pelvic ...

The objective of this study is to evaluate the oncologic outcomes in early-stage cervical cancer by comparing two groups of patients over the ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8026927/

Sentinel lymph node biopsy in early stage cervical cancer

The aim of this study was to determine the specific side detection rate of the sentinel lymph node biopsy and the accuracy in predicting ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0090825825000551

Sentinel lymph node biopsy at the time of hysterectomy for ...

Sentinel lymph node dissection at the time of hysterectomy for cervical cancer is cost-effective. •. Sentinel lymph node dissection for cervical cancer ...

4.

international-journal-of-gynecological-cancer.com

international-journal-of-gynecological-cancer.com/article/S1048-891X(24)00554-1/fulltext

Sentinel lymph node biopsy alone in the management ...

At least one sentinel lymph node (SLN) was detected in patients with early cervical cancer (<2 cm) and bilateral detection was 83%. The overall rate of lymph ...

5.

mdpi.com

mdpi.com/1648-9144/61/9/1660

Sentinel Lymph Node Dissection—Novelty, Trend, or a ...

However, data suggest that only 15–20% of patients in early stages have nodal metastases, indicating that the majority undergo pelvic lymphadenectomy without ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S2468294224000285

Effectiveness of sentinel lymph node biopsy and bilateral ...

This prospective study, which focused on 20 women with early-stage cervical cancer, was carried out between June 2016 and December 2017.

7.

gynecologiconcology-online.net

gynecologiconcology-online.net/article/S0090-8258(25)00055-1/fulltext

Sentinel lymph node biopsy at the time of hysterectomy for ...

Sentinel lymph node dissection should be performed when feasible at the time of hysterectomy for cervical cancer. Abstract. Objective. Standard ...

8.

journals.lww.com

journals.lww.com/jcma/fulltext/2025/03000/comparison_of_clinical_outcomes_in_women_with.7.aspx

Lymphadenectomy vs sentinel lymph node biopsy

SLN biopsy does not seem to be associated with an inferior survival outcome compared with conventional lymphadenectomy in women with early primary cervical ...