Phase 3 Ovarian Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are under 40 years old at the time of joining the trial.
• Females who have already started their periods, and whose first period began more than 6 months before joining the trial.
• People who have been newly diagnosed with their first cancer — breast cancer (breast carcinoma) is not included, but other types of tumours that start in the breast (such as sarcoma or lymphoma) are allowed.
• People whose cancer treatment plan includes at least one specific chemotherapy drug from a group called alkylating agents (such as cyclophosphamide, ifosfamide, procarbazine, chlorambucil, carmustine, lomustine, melphalan, thiotepa, busulfan, or nitrogen mustard), given with the aim of curing the cancer.
• For people under 20 years old: the planned chemotherapy dose must reach a certain minimum level (≥ 4 g/m² cumulative cyclophosphamide equivalent dose — confirm with trial site for what this means in individual cases); for people aged 20 and over, any planned dose of these drugs is permitted.
• The patient and/or their parents or legal guardians must be willing and able to sign a written consent form.
• All required institutional, FDA, and NCI guidelines for participation in human studies must be satisfied.

Who may not be able to join:

• People whose treatment plan includes radiation to the pelvis, or high-dose radiation to a part of the brain called the hypothalamus (30 Gy or more), including total body irradiation.
• People whose treatment plan includes surgical removal of both ovaries.
• People who have a condition present from birth that is linked to infertility or reduced ovarian function from the start — for example, Turner's Syndrome, Fragile X premutation, or Down syndrome.
• People who have a pre-existing seizure disorder, a heart condition called congenital long QT syndrome, a condition called pseudotumor cerebri, or a history of blood clots in the lungs or veins, or a heart attack.
• People who have received a long-acting (depot) form of a type of hormone drug called a GnRH agonist within the 6 months before joining the trial (note: a short-acting injectable form used for egg retrieval, or the use of oral or other hormonal contraceptives, does not prevent participation — confirm details with trial site).
• People who have previously received systemic (whole-body) chemotherapy — though prior use of steroids or chemotherapy given directly into the spinal fluid is permitted.
• People who have previously had radiation to the pelvis, or high-dose radiation to the hypothalamus (30 Gy or more), including total body irradiation.
• People who are currently pregnant.
• People who are breastfeeding and plan to continue breastfeeding throughout the treatment period (approximately 24 weeks per dose).
• People who are sexually active and able to become pregnant but have not agreed to use an effective form of contraception for the full duration of the treatment period (approximately 24 weeks per dose).

Important: Always verify eligibility with the trial site directly before applying.