Sentinel Node Biopsy for Early Cervical Cancer

(SENTICOLIII Trial)

Recruiting at 111 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

989 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment SLN biopsy only, SLN biopsy + PLN dissection for early cervical cancer?

Research shows that sentinel lymph node (SLN) biopsy can accurately predict the absence of cancer spread in early cervical cancer, potentially reducing the need for more extensive surgery. Studies indicate that SLN biopsy is less invasive and has high sensitivity for detecting cancer spread, making it a promising option for managing early cervical cancer. ^{1 2 3 4 5}

Is sentinel node biopsy safe for early cervical cancer?

Sentinel node biopsy for early cervical cancer aims to reduce surgical complications and has been studied for its accuracy and safety. However, there is limited evidence on its long-term safety compared to more extensive procedures, and some concerns remain about its reliability in detecting small cancer spread. ^{1 3 4 6 7}

How does the sentinel lymph node biopsy treatment differ from other treatments for early cervical cancer?

The sentinel lymph node (SLN) biopsy treatment for early cervical cancer is unique because it targets specific lymph nodes to check for cancer spread, potentially avoiding the need for more extensive lymph node removal. This approach can help detect unusual drainage patterns and micrometastases (tiny cancer spread) while minimizing surgical intervention compared to traditional methods that involve removing many lymph nodes. ^{1 4 5 8 9}

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".

Research Team

Fabrice Lecuru, MD PhD

Principal Investigator

Institut Curie

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.

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Incorporation of sentinel lymph node biopsy in cervical cancer surgery: Recent U.S. trends. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Histopathologic Validation of the Sentinel Node Technique for Early-Stage Cervical Cancer Patients. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Sentinel lymph node (SLN) concept in cervical cancer: Current limitations and unanswered questions. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Bilateral negative sentinel nodes accurately predict absence of lymph node metastasis in early cervical cancer: results of the SENTICOL study. [2011]

5. United States pubmed.ncbi.nlm.nih.gov

The sentinel node technique detects unexpected drainage pathways and allows nodal ultrastaging in early cervical cancer: insights from the multicenter prospective SENTICOL study. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Sentinel node (SLN) biopsy in the management of locally advanced cervical cancer. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Sentinel lymph node biopsy alone in the management of early cervical carcinoma. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Sensitivity and negative predictive value for sentinel lymph node biopsy in women with early-stage cervical cancer. [2022]

9. England pubmed.ncbi.nlm.nih.gov

A prospective multicenter trial on sentinel lymph node biopsy in patients with early-stage cervical cancer (SENTIX). [2020]