Phase III trial on hormonal therapy versus standard chemotherapy for Estrogen/Progesterone Receptor positive low-grade serous Epithelial ovarian cancer.

Phase 1

• Conditions: Patients with a low-grade serous epithelial carcinoma of the ovary (LGSCO) including cancer of fallopian tube and peritoneum, FIGO III-IV stage and with ER+ and/or PgR+ after primary surgery are eligible.; MedDRA version: 21.1Level: PTClassification code 10070907Term: Ovarian cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10070908Term: Ovarian cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-003066-39-IT
• Lead Sponsor: ENTE OSPEDALIERO OSPEDALI GALLIERA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-26
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 130

Inclusion Criteria

1.Age = 18 years.
2.Newly diagnosed, low-grade serous carcinoma of the ovary including cancer of fallopian tube and peritoneum (invasive micropapillary serous carcinoma or invasive grade 1 serous carcinoma). This is to be confirmed by a central pathology review performed at the Coordinating Centre.
3.Immunohistochemically determined positivity (= 10%) for PgR and/or ER expression. This is to be confirmed by centralized review.
4.Patients must have undergone an upfront surgery with maximal cytoreductive effort, with either optimal or suboptimal residual disease status.
5.Stage III-IV according to 2018 FIGO classification.
6.Postmenopausal status (>12 consecutive months without menstruation) or patients who have undergone a bilateral salpingo-oophorectomy.
7.Randomization must take place within 60 days of primary cytoreductive surgery.
8.Eastern Cooperative Oncology Group - performance status (ECOG-PS) 0-1.
9.To be able to take oral medications.
10.Adequate bone marrow, hepatic and renal functions as defined below:
-Absolute neutrophil count (ANC) = 1500/mm3
-Platelets = 100,000/mm3
-Hemoglobin = 10.0 g/dL
-Total bilirubin = 1.5 x Upper Limit of Normal (ULN)
-ALT and AST = 3.0 x ULN
-Alkaline phosphatase = 2.5 x ULN
-Albumin = 2.8 g/dL
-Serum creatinine = 1.5 x ULN.
11.Written informed consent obtained prior to any study-specific procedure.
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 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1.Other malignancy within the last 5 years, except for non-melanoma skin cancer adequately treated.
2.Neoadjuvant chemotherapy or radiotherapy for the treatment of this disease.
3.Previous hormonal therapy for the treatment of this disease.
4.Known hypersensitivity to letrozole or known hypersensitivity/intolerance to carboplatin/paclitaxel therapy.
5.Active or uncontrolled systemic infection.
6.Known central nervous system metastases.
7.Severe cardiac disease, such as myocardial infarction or unstable angina within 6 months prior to randomization.
8.New York Heart Association (NYHA) Class III or greater congestive heart failure.
9.Neuropathy grade 2 or higher.
10.History of fractures of the spine or femur not properly treated.
11.Known osteoporosis (T score of -2.5 or lower) not adequately treated with bisphosphonates or RANKL inhibitors (A dual-energy x-ray absorptiometry (DEXA) of the femoral neck is recommended).
12.Concurrent severe medical problems or any condition that would significantly limit full compliance with the study.

Study & Design

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