Predicting Adjuvant Post-operative Radiation Therapy in Patients With Cervical Cancer Stage IB2

NCT ID: NCT04868097

Last Updated: 2021-04-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2023-03-31

Brief Summary

A pre- operative evaluation for the presence of intermediate risk factors prior to surgery may allow for better patient counselling, modify the course of surgery or select patients to undergo primary chemo- radiation.

The purpose of this study is to validate that the presence of histological risk factors in a pre-operative large loop biopsy highly correlates with post-operative histological evaluation and the subsequent indication for post-operative chemo-radiation

Detailed Description

Patients with cervical cancer who are scheduled for radical hysterectomy and underwent a pre- operative MRI and PET- CT that have demonstrated a tumor ≥2- 4cm cm and the absence of nodal metastasis on imaging will be offered to give consent and participate.

After anesthesia and immediately prior to surgery, the surgeon will perform a large loop biopsy of depth of 1.5 and a diameter of 1.0 cm from the cervical tumor. Hemostasis can be achieved by the usual measures or by packing. Surgery will follow immediately as planned.

In patient who in the course of the preoperative evaluation underwent large loop biopsy histologic analysis of this biopsy will be performed similarly. If the large loop specimen is appropriate (>1.5X1cm) and allows assessment of all the histologic risk factors, no repeat large loop biopsy will be performed.

In patient that the that the previous large loop biopsy is not be appropriate for complete histologic analysis and the surgeon asses that a repeat biopsy is technically feasible, a large loop biopsy will be performed prior to the radical hysterectomy as described above.

All histological evaluation will be carried out as usual in hospital in which the surgery was performed.

In addition, centralized pathological analysis will be performed in Hillel Yaffe Medical center The histopathological features to be included in the report: type of procedure, tumor site, histologic type of tumor, histologic grade, depth of stromal invasion, pattern of invasion (*), horizontal extent of stromal invasion, the distance of tumor from surgical margins, lymphovascular invasion, LVSI will be assess and reported after D2-40and CD31 immunostatins.

Descriptive demographic, clinical and pathology data will be noted. The histopathological features noted above and size of tumor as measured on MRI will be recorded.

The rate of the presence of both LVSI and invasion greater 10 mm in the pre- operative loop biopsy will be assessed.

At least 52 patients will be included in the study

Sample size calculation:

The minimal sample size required to demonstrate the non-inferiority of Method B (findings in LEEP) is 52. Assuming that the proportions of patients with the presence of both LVSI and tumor invasion greater than 10 mm, method A (standard post- surgery evaluation) and method B are 25%, with α=0.05, β=0.2, and non-inferiority margin of 15%.

Conditions

Cancer of the Cervix; Conization of the Cervix; Radiation Therapy

Keywords

cervix cancer, Radiation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

cervix biopsy

large loop electrosurgical cervix biopsy

Intervention Type: PROCEDURE

Eligibility Criteria

Exclusion Criteria

Patient who do not sign the informed consent. Patient who is scheduled for Chemoradiation Patients with large loop biopsy which is smaller than depth of 1.5 and a diameter of 1.0 cm

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Barzilai Medical Center

OTHER

Sponsor Role: collaborator

Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role: collaborator

Kaplan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Alon Ben Arie

Director of obstetrics and gynecology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kaplan Medical Center

Rehovot, , Israel

Site Status: RECRUITING

Countries

Israel

Facility Contacts

Alon Ben arie, MD

Role: primary

Yael Avidan, MD

Role: backup

Other Identifiers

0186-20-KMC

Identifier Type: OTHER

Identifier Source: secondary_id

0186-20-KMC

Identifier Type: -

Identifier Source: org_study_id