HPVDNA02: FDG-PET and Circulating HPV in Patients With Cervical Cancer Treated With Definitive Chemoradiation (II)

Sponsor

University Health Network, Toronto (Other)

Overall Status

Recruiting

CT.gov ID

NCT03853915

Collaborator

Sunnybrook Health Sciences Centre (Other)

Enrollment

Location

Arm

80.3

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Nearly all cervical cancers are caused by the human papilloma virus (HPV), which can be detected in cancer tissue by laboratory tests. There is evidence that the virus can also be detected from a blood sample to monitor the effects of treatment. Previous studies have shown that a special test called 18F-Fluorodeoxyglucose (FDG) Positron Emission Tomography/Computed Tomography (PET-CT) at 3 months after treatment may predict survival in cervical cancer.

The purpose of this study is to see how well the FDG-PET Scan and blood tests for HPV can detect leftover cervical cancer cells after treatment. This study is not a particular form of treatment and patients will receive standard of care treatment.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer	Diagnostic Test: [18-F]- FDG - PET	N/A

Detailed Description

Cervical cancer is the 4th most common malignancy in women worldwide. A significant proportion of women with locally advanced cervical cancer are primarily managed with chemotherapy and radiotherapy which has improved the 5-year survival and disease-free survival; however both local and distant recurrences still remain to be challenges after treatment.

A prospective study has shown that metabolic response on post-therapy FDG-PET scan at 3 months to be predictive of progression-free and overall survival in patients with locally advanced cervical cancer. It may also predict patterns of failures for these patients.

HPV is recognized as a necessary cause of the vast majority of cervical cancer and HPV DNA has been detected in circulation from patients with cervical cancer and oropharyngeal cancer at diagnosis and at the time of relapse. Despite the promising potential of HPV DNA to monitor response and detect recurrence at an early stage, no study has evaluated serial HPV DNA and its association with PET response and survival.

We have recently reported preliminary data from a feasibility study (HPVDNA01) on 20 patients. Detectable HPV DNA at the end of cervical radiation therapy predated the clinical diagnosis of metastases and was associated with inferior progression-free survival. Also, 3 month plasma HPV DNA level was more accurate than 3-month FDG PET imaging in detecting leftover disease. This follow-up study aims to validate the clinical utility of plasma HPV DNA detection.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

64 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Newly diagnosed FIGO stage IB-IVA cervical cancer patients planned for definitive chemoradiation will be accrued to study and will have: FDG PET Scan at 3 month time point. Blood sample to measure HPV DNA at time point baseline, end of radiotherapy, 4-6 weeks and 3 months post completion of definitive radiotherapy.Newly diagnosed FIGO stage IB-IVA cervical cancer patients planned for definitive chemoradiation will be accrued to study and will have:FDG PET Scan at 3 month time point. Blood sample to measure HPV DNA at time point baseline, end of radiotherapy, 4-6 weeks and 3 months post completion of definitive radiotherapy.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

FDG-PET and Circulating HPV in Patients With Cervical Cancer Treated With Definitive Chemoradiation (II)

Actual Study Start Date :

Apr 23, 2019

Anticipated Primary Completion Date :

Dec 30, 2024

Anticipated Study Completion Date :

Dec 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FDG PET Scan [F-18] - FDG PET Scan and blood sample to measure HPV DNA	Diagnostic Test: [18-F]- FDG - PET [F-18]-FDG Injection is an intravenous diagnostic radiopharmaceutical used for Positron Emission Tomography. While this is not the subject of investigation in this study, [F-18]-FDG will be used in the PET imaging assessment of study participants during their 3 month follow-up post-treatment.

Arm

Intervention/Treatment

Experimental: FDG PET Scan

[F-18] - FDG PET Scan and blood sample to measure HPV DNA

Diagnostic Test: [18-F]- FDG - PET

[F-18]-FDG Injection is an intravenous diagnostic radiopharmaceutical used for Positron Emission Tomography. While this is not the subject of investigation in this study, [F-18]-FDG will be used in the PET imaging assessment of study participants during their 3 month follow-up post-treatment.

Outcome Measures

Primary Outcome Measures

Progression-free survival rate [up to 5 years]
The progression-free survival rate of patients with and without detectable plasma HPV DNA post treatment

Secondary Outcome Measures

Plasma HPV DNA levels [Up to 3 months]
The accuracy of 3-month FDG-PET or 3-month HPV DNA for predicting relapse will be estimated.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix, FIGO stage IB-IVA
3.1.2 Planned for radical radiotherapy and concurrent cisplatin chemotherapy.
3.1.3 Age ≥ 18 years.

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.
Other cervical cancer tumor histologies (e.g. small cell, serous)
Contraindications to 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Health Network, The Princess Margaret	Toronto	Ontario	Canada	M5G 2M9

Sponsors and Collaborators

University Health Network, Toronto
Sunnybrook Health Sciences Centre

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT03853915

Other Study ID Numbers:

18-6277

First Posted:

Feb 26, 2019

Last Update Posted:

Oct 6, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Health Network, Toronto

Cervical Cancer

PET Scan

HPV DNA

Additional relevant MeSH terms:

Uterine Cervical Neoplasms

Study Results

No Results Posted as of Oct 6, 2021