FDG-PET and Circulating HPV in Patients With Cervical Cancer

NCT ID: NCT02388698

Last Updated: 2021-09-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-23
• Study Completion Date: 2023-12-31

Brief Summary

The addition of concurrent chemotherapy to definitive radiation has improved the 5-year survival of women with locally advanced cervical cancer to 58%. To determine if plasma HPV DNA predates clinical recurrence and/or improves the accuracy of metabolic response on FDG-PET at 3 months post completion of radical chemo-radiation in patients with locally advanced cervical cancer. Post therapy FDG-PET can help predict progression free survival and overall survival. In addition plasma HPV can be used to monitor response and detect early recurrence. Prospective study will recruit 20 patients with locally advanced cervical cancer to determine if plasma HPV DNA predates clinical recurrence and/or improves the accuracy response on post-therapy FDG-PET scan at 3 months.

Detailed Description

The addition of concurrent chemotherapy to definitive radiation has improved the 5-year survival of women with locally advanced cervical cancer to 58%, there is much room for improvement. Post-therapy FDG-PET at 3 months can help predict progression-free and overall survival. Tumors continually shed their DNA into the circulation, where it can be accessed to measure disease burden. Cervical cancer is caused by Human Papilloma Virus (HPV); plasma HPV DNA could be used to monitor response and detect recurrence early. While plasma HPV DNA has been shown to correlate with prognosis and predict recurrence in other cancers, there is limited data in locally advanced cervical cancer.

This prospective multi-institutional study will recruit 20 patients with locally advanced cervical cancer to determine if plasma HPV DNA predates clinical recurrence and/or improves the accuracy response on post-therapy FDG-PET scan at 3 months. Patients will undergo phlebotomy at the following time-points for the measurement of circulating HPV DNA levels: a) baseline; b) end of radiotherapy;c) 3 months post completion of chemoradiation, along with 3-month FDG-PET and d) at recurrence. This study will provide preliminary estimates of the correlation between plasma HPV DNA level, PET finding and clinical outcome, and inform sample size calculation for a larger study. If proven useful in the future, plasma HPV DNA could enable the identification of patients at high risk of recurrence and individualized treatment.

Conditions

Cervical Cancer

Study Design

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

Study Groups

Cervical Swab, PET-CT and plasma HPV

Participants will have a cervical swab, and plasma HPV at baseline. In addition, a plasma HPV test drawn after completion of radiation. 3 months post chemoradiation, patients will have a PET-CT and plasma HPV completed. Plasma HPV will be drawn at progression/recurrence, if applicable.

Group Type: EXPERIMENTAL

Cervical swab

Intervention Type: PROCEDURE

Cervical Swab at baseline.

HPV testing at recurrence, if applicable.

PET-CT

Intervention Type: RADIATION

PET-CT will be completed 3 month post chemoradiation.

Plasma HPV

Intervention Type: BIOLOGICAL

Plasma HPV will be drawn at baseline, post radiation, 3 month post chemoradiation and at progression (if necessary).

Interventions

Cervical swab

Cervical Swab at baseline.

HPV testing at recurrence, if applicable.

Intervention Type: PROCEDURE

PET-CT

PET-CT will be completed 3 month post chemoradiation.

Intervention Type: RADIATION

Plasma HPV

Plasma HPV will be drawn at baseline, post radiation, 3 month post chemoradiation and at progression (if necessary).

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix, FIGO stage IB-IVA
• planned for radical radiotherapy and concurrent cisplatin chemotherapy.
• Age ≥ 18 years.
• Life expectancy of greater than 3 months.

Exclusion Criteria

• Evidence of distant metastases (suspicious paraaortic nodes below the renal vessels allowed if they will be encompassed within the radiation field)
• Patients who have received any anticancer treatment for their cervical cancer.
• Eastern Cooperative Oncology Group (ECOG) performance status > 2
• Other cervical cancer tumor histologies (e.g. small cell, serous)
• Contraindications to 18FDG PET-CT
• Inability to lie supine for radiation and/or 18FDG PET-CT
• Contraindication to radiotherapy (e.g. severe Crohn's disease)
• Contraindication to chemotherapy (e.g. non-reversible renal failure)
• History of another invasive malignancy, except for non-melanoma skin cancer or tumors curatively treated with no evidence of disease for ≥ 5 years.
• Known pregnancy or lactating

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

Sponsors

Princess Margaret Hospital, Canada

OTHER

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. Eric Leung

Radiation Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric Leung, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Research Institute

Locations

Princess Margaret Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

HPVDNA01

Identifier Type: -

Identifier Source: org_study_id