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Procedure
Sentinel Node Biopsy for Early Cervical Cancer (SENTICOLIII Trial)
N/A
Waitlist Available
Led By Fabrice Lecuru, MD PhD
Research Sponsored by Centre Hospitalier Universitaire de Besancon
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
I 1. Patient must be ≥ 18 years old, I 2. With squamous or adenocarcinoma or adenosquamous carcinoma of the cervix (proven by biopsy or cone biopsy), I 3. Stage Ia1 with lymphovascular emboli, Ia2, Ib1 IIa1, Ib2 (clinical stage) of the 2018 FIGO classification (see appendix 1), I 4. Maximum diameter ≤ 40 mm by clinical examination and/or magnetic resonance imaging (MRI), I 5. No suspicious node on pelvic MRI with an exploration up to the left renal vein (according to RECIST 1.1), I 6. ECOG performance status 0-2 (see appendix 2), I 7. Signed informed consent and ability to comply with follow-up, I 8. French subjects: in France, a subject will be eligible for inclusion in this study only if either affiliated to, or a beneficiary of, a social security category.
Patient must be ≥ 18 years old
Must not have
Previous chemotherapy and/or radiation therapy for the cervical cancer (previous brachytherapy is accepted)
Patients with synchronous cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 3
Awards & highlights
No Placebo-Only Group
Summary
"This trial is a large international study that aims to confirm the effectiveness of using the Sentinel Lymph Node mapping technique in early cervical cancer. They will compare patients who only have the SLN procedure with patients
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed, surgical procedures like SLN biopsy can cause pain, swelling, infection risk at the incision site, possible damage to nearby organs or tissues, and complications from anesthesia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My cervical cancer diagnosis was confirmed by a biopsy.
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My cancer is at an early to mid-stage according to the 2018 FIGO classification.
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My tumor is 40 mm or smaller according to a physical exam or MRI.
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My pelvic MRI showed no suspicious nodes up to my left kidney.
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I can take care of myself and perform daily activities.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had chemotherapy or radiation for cervical cancer before.
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I have more than one type of cancer at the same time.
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I have had cancer in my pelvis or abdomen before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ year 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 3
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Disease Free Survival (DFS)
Health-related quality of life (HR-QoL)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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.
Find a Location
Who is running the clinical trial?
Centre Hospitalier Universitaire de BesanconLead Sponsor
464 Previous Clinical Trials
827,450 Total Patients Enrolled
ARCAGY/ GINECO GROUPOTHER
63 Previous Clinical Trials
14,857 Total Patients Enrolled
European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
39 Previous Clinical Trials
17,217 Total Patients Enrolled
Fabrice Lecuru, MD PhDPrincipal InvestigatorInstitut Curie