Autologous Heterotopic Fresh Ovarian Graft in Woman With LACC Eligible for Pelvic Radiotherapy Treatment.

MARILIA ALBANEZI BERTOLAZZI

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Locally Advanced Cervical Carcinoma; Premature Ovarian Failure

Treatments: Procedure: Ovarian graft

Study type: Interventional

Funder types: Other

Identifiers

NCT05462379

NP1782

Details and patient eligibility

About

Pelvic chemoradiotherapy (CRT) is an effective treatment for Locally Advanced Cervical Cancer (LACC). However, CRT induces premature ovarian failure ceasing the production of ovarian hormones. This may lead to severe consequences to the patient's life quality, sexuality and overall healthy. An acceptable treatment to minimize the adverse effects caused by the lack of ovarian hormones is hormonal replacement but less than 40% of the patients younger than 50 years have access to this treatment. A second alternative treatment is ovarian transposing which is a surgical technique with variable success rate depending on how far the ovaries are from the radiotherapy field. A third, more promising, alternative is involves using autologous ovarian tissue as a graft in tissues far from the radiotherapy field. This treatment has the potential of maintaining the natural ovarian hormones production at a lower-cost and requiring a simpler procedure. The primary objective of this randomized phase 1-2 clinical trial is to validate the feasibility of ovarian tissue engraft into fatty tissue and its endocrine functionality.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Standard treatment

No Intervention group

Description:

10 patients: Pelvic Chemoradiotherapy

Ovarian Graft

Experimental group

Description:

10 patients: Before the beginning of pelvic radiotherapy, one of the ovaries will be removed by laparoscopy. Ovary slices of 1-2 mm will be prepared in sterile environment and engrafted in the fatty tissue of inner tight. One representative fragment will undergo histologic evaluation. These procedures will be done in the same surgical time.

Treatment:

Procedure: Ovarian graft