SEntinel Lymph node in EarLY ovarian cancer: the SELLY protocol

Phase 1

• Conditions: ADVANCED OVARIAN CANCER; MedDRA version: 21.1Level: PTClassification code 10070906Term: Ovarian cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10070905Term: Ovarian cancer stage ISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-001088-58-IT
• Lead Sponsor: FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-31
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 176

Inclusion Criteria

1. Diagnosis of EOC macroscopically limited to the ovaries or the pelvis (surgical stage I-II)
2. Surgical staging
3. Age between 18 and 80
4. Performance Status (ECOG) <= 2, an adequate respiratory, hepatic, cardiac, bone marrow, liver and renal function (Creatinine Clearance > 60 mL/min according to Cockroft formula)
5. Negative preoperative CT scan imaging for positive nodes (defined as lymph modes < 1cm in their larger axis).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 56

Exclusion Criteria

1.FIGO stages III B, III C or IV
2.Mucinous histology
3.Previous surgery of the aorta, caval vein, and/or iliac vessels
4.Previous lymphadenectomy or lymph node sampling in the iliac or para-aortic region that could change the ovarian lymphatic drainage
5.Hepatic dysfunction defined as a Model for End-Stage Liver Disease score of 10 or greater, renal dysfunction defined as serum creatinine of 2.0 mg/dL or greater
6.Usage of any other tracer but ICG
7.History of allergy to ICG, iodine, iodine dyes, isosulfan blue, or triphenylmethane
8.History of a malignant lymphoma
9.History of a malignant tumor in the abdominal cavity
10.Concomitant other malignancies
11.Previous abdominal radiation therapy
12.Pregnancy or lactation
13.Refusal to provide written informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified