Triptorelin and Protection of Ovarian Reserve in Adolescents and Young Adults With Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 383
- 主要终点
- Number of enrollments of newly diagnosed AYA female cancer patients age < 40 years
研究概览
简要总结
This phase III trial compares the effect of giving triptorelin vs no triptorelin in preventing ovarian damage in adolescents and young adults (AYAs) with cancer receiving chemotherapy with alkylating agents. Alkylating agents are part of standard chemotherapy, but may cause damage to the ovaries. If the ovaries are not working well or completely shut down, then it will be difficult or impossible to get pregnant in the future. Triptorelin works by blocking certain hormones and causing the ovaries to slow down or pause normal activity. The triptorelin used in this study stays active in the body for 24 weeks or about 6 months after a dose is given. After triptorelin is cleared from the body, the ovaries resume normal activities. Adding triptorelin before the start of chemotherapy treatment may reduce the chances of damage to the ovaries.
详细描述
PRIMARY OBJECTIVES:
I. Determine the feasibility of conducting a cross network, multi-site, randomized clinical trial of triptorelin among newly diagnosed adolescent and young adult (AYA) female cancer patients age < 40 years (exclusive of breast cancer).
II. Measure ovarian reserve via anti-Mullerian hormone (AMH) at 2-years post completion of alkylating agent-containing chemotherapy among randomized patients.
SECONDARY OBJECTIVES:
I. Collect information on the longitudinal trajectory of change in AMH and other ovarian hormone levels from cancer diagnosis to 2 years post cancer treatment completion among randomized patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 39 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •< 40 years of age at the time of enrollment
- •Patient must be a post-menarchal female and report that their initial menstrual period occurred > 6 months prior to enrollment. (Current menstrual status is not part of the inclusion criteria.)
- •Newly diagnosed with first cancer, exclusive of breast cancer.
- •Note: Apart from breast carcinoma, other tumor types originating in the breast are permitted (e.g., sarcoma, lymphoma).
- •Planned treatment must include one or more of the following alkylating agents delivered with curative intent: cyclophosphamide, ifosfamide, procarbazine, chlorambucil, carmustine (BCNU), lomustine (CCNU), melphalan, thiotepa, busulfan, nitrogen mustard, or dacarbazine (DTIC).
- •Expected cumulative cyclophosphamide equivalent dose (CED):
- •For patients < 20 years of age at enrollment, the expected alkylator dose must be ≥ 4 g/m^2 cumulative CED calculated according to the equation and specified drugs listed. Dacarbazine is not an eligible drug in this age group.
- •For patients ≥ 20 years of age and < 35 years old at enrollment, any planned alkylator dose is permitted. Eligible patients must receive at least one of the alkylators listed below that contribute to CED. Dacarbazine is not an eligible drug in this age group.
- •For patients ≥ 35 years of age at enrollment, any planned alkylator dose is permitted. Eligible patients must receive at least one of the alkylators listed that contribute to CED and/or dacarbazine, which IS an eligible drug in this age group.
- •Note that CED includes all administration routes: intravenous (IV), oral (PO), IM.
- •The planned total duration of therapy with eligible alkylators is expected to be completed within one year after enrollment. Note: treatment plans with prolonged maintenance periods extending beyond one year are permitted so long as those maintenance treatments are not expected to contain eligible alkylators.
- •All patients and/or their parents or legal guardians must sign a written informed consent.
- •All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.
排除标准
- •Any planned radiation to the pelvis; or cranial radiation ≥ 30 gray (Gy) to the hypothalamus, inclusive of any total body irradiation (TBI).
- •Planned bilateral oophorectomy. Note: A participant's desire to pursue alternative fertility preservation procedures (i.e., embryo, oocyte, or ovarian tissue cryopreservation) will be allowed (and in fact encouraged).
- •Congenital syndromes associated with infertility and decreased ovarian reserve at baseline. For example: Turner's Syndrome, Fragile X premutation carriers, Down syndrome, etc.
- •Pre-existing seizure disorder, congenital long QT syndrome, pseudotumor cerebri; history of pulmonary embolism, venous thrombosis, or myocardial infarction. Note: Contact study chairs if questions arise about other pre-existing conditions.
- •Receipt of long acting (depot) GnRH agonists within 6 months before enrollment. In contrast, subcutaneous GnRH agonist used for oocyte retrieval is not an exclusion; oral and other hormonal contraceptive use is also not an exclusion. Note: Please see protocol for the concomitant therapy restrictions for patients during the study treatment period. See protocol for information about oral and other hormonal contractive use during the study treatment period.
- •Receipt of systemic chemotherapy (except for steroids and intrathecal chemotherapy) more than 7 days prior to study enrollment.
- •Any prior radiation to the pelvis; or cranial radiation ≥ 30 Gy to the hypothalamus, inclusive of any total body irradiation (TBI).
- •Patients who are pregnant are not eligible. A pregnancy test is required for female patients of childbearing potential.
- •Lactating females who plan to breastfeed their infants for the duration of triptorelin therapy (24 weeks per dose).
- •Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of triptorelin therapy (24 weeks per dose).
研究组 & 干预措施
Arm A (triptorelin)
Patients receive triptorelin IM up to 14 days prior to or within 7 days after the start of standard chemotherapy. For patients whose chemotherapy exceeds 24 weeks, a second dose of triptorelin may be given 24 weeks after the first dose at the treating physician's discretion. Patients also undergo blood sample collection throughout the study.
干预措施: Biospecimen Collection (Procedure)
Arm A (triptorelin)
Patients receive triptorelin IM up to 14 days prior to or within 7 days after the start of standard chemotherapy. For patients whose chemotherapy exceeds 24 weeks, a second dose of triptorelin may be given 24 weeks after the first dose at the treating physician's discretion. Patients also undergo blood sample collection throughout the study.
干预措施: Survey Administration (Other)
Arm A (triptorelin)
Patients receive triptorelin IM up to 14 days prior to or within 7 days after the start of standard chemotherapy. For patients whose chemotherapy exceeds 24 weeks, a second dose of triptorelin may be given 24 weeks after the first dose at the treating physician's discretion. Patients also undergo blood sample collection throughout the study.
干预措施: Triptorelin Pamoate (Drug)
Arm B (usual care)
Patients receive standard chemotherapy. Patients also undergo blood sample collection throughout the study.
干预措施: Survey Administration (Other)
Arm B (usual care)
Patients receive standard chemotherapy. Patients also undergo blood sample collection throughout the study.
干预措施: Best Practice (Other)
Arm B (usual care)
Patients receive standard chemotherapy. Patients also undergo blood sample collection throughout the study.
干预措施: Biospecimen Collection (Procedure)
Arm B (usual care)
Patients receive standard chemotherapy. Patients also undergo blood sample collection throughout the study.
干预措施: Electronic Health Record Review (Other)
Arm A (triptorelin)
Patients receive triptorelin IM up to 14 days prior to or within 7 days after the start of standard chemotherapy. For patients whose chemotherapy exceeds 24 weeks, a second dose of triptorelin may be given 24 weeks after the first dose at the treating physician's discretion. Patients also undergo blood sample collection throughout the study.
干预措施: Electronic Health Record Review (Other)
结局指标
主要结局
Number of enrollments of newly diagnosed AYA female cancer patients age < 40 years
时间窗: Up to 2 years post-chemotherapy
Number of enrollments by the end of the DOD funded grant period, and ideally prior to Year 4 to enable greater duration of follow-up time.
Accrual rates of newly diagnosed AYA female cancer patients age < 40 years
时间窗: Up to 2 years post-chemotherapy
Accrual rates of newly diagnosed AYA female cancer patients age \< 40 years. Over the second half of the funding period, demonstrate a positive trajectory in accrual rates that provides data to inform future funding proposals that would seek to complete the overall larger study within a typical 5-year funding period.
Anti-mullerian hormone (AMH) levels
时间窗: At 2 years post-chemotherapy
Feasibility of measuring AMH at two years post completion of alkylating agent-containing chemotherapy among randomized patients.
次要结局
- Estrogen deprivation symptoms: Hot flashes(Up to 2 years post-chemotherapy)
- Estrogen deprivation symptoms: Headaches(Up to 2 years post-chemotherapy)
- Estrogen deprivation symptoms: Vaginal/vulvar symptoms(Up to 2 years post-chemotherapy)
- Estrogen deprivation symptoms: Sexual function(Up to 2 years post-chemotherapy)
- Sexual Health(Up to 2 years post-chemotherapy)
- Menstrual patterns(Up to 2 years post-chemotherapy)
- Global health-related quality of life: Anxiety(Up to 2 years post-chemotherapy)
- Global health-related quality of life: Fatigue(Up to 2 years post-chemotherapy)
- Global health-related quality of life: Depression(Up to 2 years post-chemotherapy)
- Global health-related quality of life: Sleep disturbance(Up to 2 years post-chemotherapy)
- Global health-related quality of life: Participation in social activities(Up to 2 years post-chemotherapy)
- Longitudinal AMH along with other ovarian hormone levels(Up to 2 years post-chemotherapy)