Letrozole treatment for low-grade serous ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III trial evaluates the effectiveness of Letrozole compared to standard chemotherapy in patients with hormone receptor positive low-grade serous epithelial ovarian carcinoma. The study aims to determine if Letrozole can significantly prolong progression-free survival (PFS) and improve quality of life compared to carboplatin and paclitaxel. It includes a multicenter approach across various hospitals in Italy and incorporates translational objectives to analyze tumor characteristics through next-generation sequencing. The trial will also assess safety and response rates to the treatments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

I - 1. Age ≥ 18 years. I - 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 via nuclear p53 immunohistochemistry testing by a central pathology review performed at the Coordinating Centre.

I - 3. Immunohistochemically determined positivity (≥ 10%) for ER and/or PgR expression. This is to be confirmed by centralized review.

I - 4. Patients must have undergone an upfront surgery with maximal cytoreductive effort, with either optimal or suboptimal residual disease status.

I - 5. Stage III-IV according to 2018 FIGO classification. For proper staging:

* Patients must have undergone contrast-enhanced CT-scan of the chest, abdomen and pelvis within 28 days prior to randomization. If CT-scan is not recommended (e.g. for allergy to contrast agent) MRI or 18F-FDG PET/CT-scan are allowed.
* The imaging evaluation must be accompanied by an anamnestic and physical examination within 14 days prior to randomization.

I - 6. Postmenopausal, defined as any of the following criteria:

* Patients who underwent bilateral salpingo-oophorectomy;
* Monolateral salpingo-oophorectomy, amenorrhea for 12 or more consecutive months and age ≥60 years;
* Monolateral salpingo-oophorectomy, amenorrhea for 12 or more consecutive months, age \<60 years and FSH and serum estradiol levels within the laboratory's reference ranges for post-menopausal women.

I - 7. Randomization must take place within 60 days of primary cytoreductive surgery.

I - 8. Eastern Cooperative Oncology Group - performance status (ECOG-PS) 0-1.

I - 9. To be able to take oral medications.

I - 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.

I - 11. Written informed consent obtained prior to any study-specific procedure.

Exclusion Criteria:

E - 1. Other malignancy within the last 5 years, except for non-melanoma skin cancer adequately treated.

E - 2. Neoadjuvant chemotherapy or radiotherapy for the treatment of this disease.

E - 3. Previous hormonal therapy for the treatment of this disease.

E - 4. Known hypersensitivity to letrozole or known hypersensitivity/intolerance to carboplatin/paclitaxel therapy.

E - 5. Active or uncontrolled systemic infection.

E - 6. Known central nervous system metastases.

E - 7. Severe cardiac disease, such as myocardial infarction or unstable angina within 6 months prior to randomization.

E - 8. New York Heart Association (NYHA) Class III or greater congestive heart failure.

E - 9. Neuropathy grade 2 or higher.

E - 10. History of fractures of the spine or femur not properly treated.

E - 11. Known osteoporosis (dual-energy x-ray absorptiometry (DEXA) of the femoral neck T score of -2.5 or lower) not adequately treated with bisphosphonates or RANKL inhibitors.

E - 12. Concomitant use of inducers of CYP3A4 (e.g. phenytoin, rifampicin, carbamazepine, phenobarbital, and St. John's Wort) which may reduce exposure to letrozole. Concomitant use of medicinal products with a narrow therapeutic index that are substrates for CYP2C19 (e.g. phenytoin, clopidrogel) that may have their systemic serum concentrations altered by letrozole.

E - 13. Concurrent severe medical problems or any condition that would significantly limit full compliance with the study.

Where it's running

• Ospedale San Donato
  Arezzo, Ar, Italy Recruiting
• Ospedale degli Infermi
  Ponderano, Bi, Italy Recruiting
• Ospedale San Martino
  Belluno, Bl, Italy Recruiting
• Fondazione Poliambulanza
  Brescia, Bs, Italy Recruiting
• ASST degli Spedali Civili di Brescia
  Brescia, Bs, Italy Recruiting
• Ospedale Sant'Anna
  Como, Co, Italy Recruiting

Study contacts

• Principal investigator: Andrea DeCensi, MD — E.O.Ospedali Galliera
• Study coordinator: Andrea DeCensi, Prof.
• Email: andrea.decensi@galliera.it
• Phone: +39(0)105634501

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.