Study on Letrozole vs. Chemotherapy (Carboplatin and Paclitaxel) for Patients with Advanced Low-Grade Serous Ovarian Cancer with Hormone Receptors

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What is this study about?

This clinical trial is focused on studying a type of cancer known as low-grade serous epithelial ovarian cancer, which can also affect the fallopian tubes and the lining of the abdomen. This cancer is characterized by being positive for estrogen and/or progesterone receptors, which means that these hormones can promote the growth of the cancer cells. The study aims to compare the effectiveness of a medication called Letrozole with standard chemotherapy treatments. Letrozole is a medication that works by reducing the levels of estrogen in the body, which may help slow down or stop the growth of cancer cells.

Participants in the study will be randomly assigned to receive either Letrozole or standard chemotherapy. The chemotherapy treatments being used in this study include Carboplatin and Paclitaxel. Carboplatin is a drug that interferes with the DNA of cancer cells, preventing them from dividing and growing. Paclitaxel, also known by code names such as Oncogel and ABI-007, works by stopping cancer cells from dividing. The study will monitor participants over a period to see which treatment is more effective in delaying the progression of the cancer.

The main goal of the study is to determine if Letrozole can provide a longer period without the cancer worsening compared to the standard chemotherapy. Participants will receive regular check-ups and assessments to track their health and the status of their cancer. The study will help researchers understand which treatment option might be better for patients with this specific type of ovarian cancer.

1 randomization

Upon joining the study, you will be randomly assigned to one of two groups. This process is called randomization. It ensures that each participant has an equal chance of receiving either the standard chemotherapy or the medication being tested, letrozole.

2 treatment initiation

If assigned to the standard chemotherapy group, you will receive carboplatin and paclitaxel through an intravenous (IV) line. This means the medication will be given directly into your vein. The specific dosage and frequency will be determined by your healthcare provider.

If assigned to the letrozole group, you will take letrozole orally in the form of a film-coated tablet. The typical dosage is 2.5 mg, taken once daily.

3 treatment duration

The duration of the treatment will depend on your response to the medication and any side effects you may experience. Your healthcare provider will monitor your progress and adjust the treatment plan as necessary.

4 regular monitoring

Throughout the trial, you will undergo regular monitoring. This includes physical examinations, blood tests, and imaging studies such as CT scans or MRIs to assess the effectiveness of the treatment and check for any side effects.

5 end of treatment

At the end of the treatment period, your healthcare provider will evaluate your overall health and the outcome of the treatment. This will include determining if the cancer has progressed or if there has been a response to the treatment.

Who Can Join the Study?

Must be 18 years or older.
Must have a newly diagnosed, low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum. This type of cancer is confirmed through a special test called nuclear p53 immunohistochemistry.
Must have cancer that shows positivity (10% or more) for estrogen receptors (ER) and/or progesterone receptors (PgR). This is confirmed by a centralized review.
Must have had surgery to remove as much of the tumor as possible, with either optimal or suboptimal results.
Cancer must be at Stage III-IV according to the 2018 FIGO classification. A detailed imaging test like a CT scan, MRI, or PET/CT scan must be done within 28 days before joining the study.
Must be postmenopausal, which means:
- Having had both ovaries removed, or
- Having had one ovary removed, no periods for 12 or more months, and being 60 years or older, or
- Having had one ovary removed, no periods for 12 or more months, being under 60, and having hormone levels in the postmenopausal range.
Must join the study within 90 days (preferably within 60 days) after the primary surgery.
Must have an ECOG performance status of 0-1, which means being fully active or having some symptoms but still able to carry out light work.
Must be able to take medications by mouth.
Must have adequate bone marrow, liver, and kidney function, as shown by specific blood test results:
- Absolute neutrophil count (ANC) of 1500/mm³ or more
- Platelets of 100,000/mm³ or more
- Hemoglobin of 10.0 g/dL or more
- Total bilirubin of 1.5 times the upper limit of normal (ULN) or less
- ALT and AST of 3.0 times the ULN or less
- Alkaline phosphatase of 2.5 times the ULN or less
- Albumin of 2.8 g/dL or more
- Serum creatinine of 1.5 times the ULN or less
Must provide written informed consent before any study-specific procedures are done.

Who Cannot Join the Study?

Patients who do not have a low-grade serous epithelial carcinoma of the ovary, including cancer of the fallopian tube and peritoneum, cannot participate.
Patients whose cancer is not at FIGO stage III-IV cannot participate. (FIGO stages are a way to describe how much cancer has spread.)
Patients whose cancer is not ER+ and/or PgR+ cannot participate. (ER+ means the cancer grows in response to estrogen, and PgR+ means it grows in response to progesterone.)
Patients who have not had primary surgery for their cancer cannot participate. (Primary surgery is the first major surgery to remove cancer.)
Only female patients can participate.
Male patients cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Azienda Unita Sanitaria Locale Di Piacenza	Piacenza	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Fakultni Nemocnice Bulovka	Prague	Czechia
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Azienda Socio Sanitaria Territoriale Dei Sette Laghi	Varese	Italy
Fondazione Poliambulanza	Brescia	Italy
Azienda Socio Sanitaria Territoriale Lariana	Como	Italy
Azienda Unita’ Locale Socio Sanitaria N. 2 Marca Trevigiana	Treviso	Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Ente Ospedaliero Ospedali Galliera Di Genova	Genoa	Italy
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Universita’ Di Pisa	Pisa	Italy
Alessandro Manzoni Hospital	Lecco	Italy
Azienda USL Toscana Centro	Prato	Italy
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Azienda USL Toscana Sud Est	Arezzo	Italy
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Azienda Sanitaria Locale Della Provincia Di Biella	Ponderano	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Universita’ Degli Studi Di Ferrara	Ferrara	Italy
Azienda Ospedaliera Universitaria Di Cagliari	Monserrato	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Hrjczfrmn Mytwuymi Syuvlj	Milan	Italy
Iychby Iwljyoyf Fdqdnqonmxkqa Ojvrxhwyxgy	Rome	Italy
Amyfvxk Owsonaoywud S Geyypohz Agonoriikm	Rome	Italy
Affgpoq Suwpsijxknqbnhh Tbppzyoazhcj Dgm Ghowq	Desenzano Del Garda	Italy
Fpqnddxm njgvhjhfp Mrpqb a Hgqvsvo	Prague	Czechia
Iciyxsln Rmdzntjxy Pau Li Swpegf Duh Tqacda Dsby Aulflsj Ijst Sixczb	Meldola	Italy
Auxdryb Ofsblmqfkir Uvnsevxdavlsw Cxmxfspwkixy Drzog Swkzvv E Dbudg Skysywa Dz Tsksfq	Turin	Italy
Aqlzimv Uyn Ijqqs Dw Rsqgxl Exujwt	Reggio Emilia	Italy
Uaropxrdqk Dsdlo Seycb Dm Rwwm Lt Skqggnhj	Rome	Italy

Trial status

Country	Status	Recruitment Start
Czechia	Not yet recruiting	01.03.2023
Italy	Recruiting	01.03.2023

Trial locations

Investigated drugs:

Letrozole is a medication used in this clinical trial to treat a specific type of ovarian cancer known as low-grade serous epithelial ovarian carcinoma. This type of cancer is positive for estrogen and/or progesterone receptors, meaning it grows in response to these hormones. Letrozole works by lowering the levels of estrogen in the body, which can help slow down or stop the growth of cancer cells that need estrogen to grow. The trial aims to see if Letrozole is more effective than the standard chemotherapy in preventing the cancer from getting worse over time.

Investigated diseases:

Low-Grade Serous Ovarian Carcinoma – This is a type of ovarian cancer that originates from the epithelial cells lining the ovary. It is characterized by slow growth and is often diagnosed at an advanced stage. The disease can also affect the fallopian tubes and the peritoneum, which is the lining of the abdominal cavity. It typically progresses by spreading locally within the pelvis and abdomen, and may eventually metastasize to distant organs. The cancer cells in this type are often positive for estrogen and/or progesterone receptors, which can influence their growth. The progression of the disease is generally slower compared to high-grade serous ovarian carcinoma.

Trial ID:

2024-516874-31-00

Protocol code:

10UCS2018

NCT ID:

NCT05601700

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Letrozole vs. Chemotherapy (Carboplatin and Paclitaxel) for Patients with Advanced Low-Grade Serous Ovarian Cancer with Hormone Receptors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?