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