NCT02388698

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
1.7 years until next milestone

Study Start

First participant enrolled

November 23, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

September 22, 2021

Status Verified

September 1, 2021

Enrollment Period

3 years

First QC Date

February 24, 2015

Last Update Submit

September 20, 2021

Conditions

Cervical Cancer

Keywords

HPV DNAPET-CTRecurrent cervical cancerchemoradiation

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in plasma HPV DNA to 3 months.

    To determine if HPV DNA predates clinical recurrence and/or improves the accuracy of metabolic response on FDG-PET scan at 3 months post completion of radical chemoradiation in patients with locally advanced cervical cancer

    Pre treatment and within the first 3 months post treatment

Study Arms (1)

Cervical Swab, PET-CT and plasma HPV

EXPERIMENTAL

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.

Procedure: Cervical swabRadiation: PET-CTBiological: Plasma HPV

Interventions

Cervical swabPROCEDURE

Cervical Swab at baseline. HPV testing at recurrence, if applicable.

Cervical Swab, PET-CT and plasma HPV
PET-CTRADIATION

PET-CT will be completed 3 month post chemoradiation.

Cervical Swab, PET-CT and plasma HPV
Plasma HPVBIOLOGICAL

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

Cervical Swab, PET-CT and plasma HPV

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G2M9, Canada

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Eric Leung, MD

    Sunnybrook Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Radiation Oncologist

Study Record Dates

First Submitted

February 24, 2015

First Posted

March 17, 2015

Study Start

November 23, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2023

Last Updated

September 22, 2021

Record last verified: 2021-09

Locations

CA(1)