Using ovarian grafts to help women with advanced cervical cancer undergoing pelvic radiotherapy.
Autologous Heterotopic Fresh Ovarian Graft in Young Woman With Locally Advanced Cervical Cancer Eligible for Pelvic Radiotherapy Treatment
This study is testing if transplanting ovarian tissue can help women with advanced cervical cancer keep their hormone levels stable while they undergo pelvic radiotherapy.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | Instituto do Cancer do Estado de São Paulo Academic / other |
| Locations | 1 site (São Paulo) |
| Trial ID | NCT05462379 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of autologous ovarian grafts in women with locally advanced cervical carcinoma who are eligible for pelvic radiotherapy. The study aims to address the issue of premature ovarian failure caused by chemoradiotherapy, which can severely impact quality of life and hormonal balance. By transplanting ovarian tissue to areas outside the radiation field, the trial seeks to maintain natural hormone production in a cost-effective and less invasive manner. The study is designed as a randomized phase 1-2 trial to evaluate the safety and efficacy of this innovative approach.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 35 years or younger with a diagnosis of locally advanced cervical cancer and no ovarian involvement.
Not a fit: Patients who have previously received treatment for cervical cancer or have rare histology tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for women undergoing pelvic radiotherapy by preserving ovarian function.
How similar studies have performed: While the approach of using autologous ovarian grafts is promising, it is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathologic diagnosis of squamous cell carcinoma or adenocarcinoma of the cervix. * FIGO 2018 staging IB3 to IVA. * Absence of ovarian involvement. * Age ≤35 Years. * Absence of metastatic disease. * Written consent. Exclusion Criteria: * Previous treatment for cervical cancer or other malignant diseases. * Rare histology tumors. * Absence of one or both ovaries.
Where this trial is running
São Paulo
- Instituto do Cancer do Estado de São Paulo — São Paulo, Brazil (Recruiting)
Study contacts
- Study coordinator: Marilia Bertolazzi, MD
- Email: marilia.bertolazzi@hc.fm.usp.br
- Phone: 5519989172189
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.