Clinical trial NCT01992861: MRI and PET Imaging in Predicting Treatment Response in Patients With Stage IB-IVA Cervical Cancer
Official title: MRI- and PET-Predictive-Assay of Treatment Outcome in Cancer of the Cervix
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cervical Adenocarcinoma
Cervical Adenosquamous Carcinoma
Cervical Squamous Cell Carcinoma, Not Otherwise Specified
Cervical Undifferentiated Carcinoma
Recurrent Cervical Carcinoma
Stage IB2 Cervical Cancer
Stage II Cervical Cancer
Stage IIA Cervical Cancer
Stage IIB Cervical Cancer
Stage III Cervical Cancer
Stage IIIA Cervical Cancer
Stage IIIB Cervical Cancer
Stage IVA Cervical Cancer
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
First posted: 2013-11-25
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stage IB2-IVA epithelial carcinoma of the cervix, including squamous cell, adeno-, and undifferentiated carcinoma, who will undergo radiation therapy for cervical cancer with curative intent.

Brief summary: This trial studies magnetic resonance imaging (MRI) and positron emission tomography (PET) imaging in predictive treatment response in patients with stage IB-IVA cervical cancer. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. PET is a procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. Comparing results of diagnostic procedures, such as MRI and PET, done before, during and after radiation and chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.

Detailed description: OUTLINE:

Patients undergo radiation therapy and receive chemotherapy per standard of care. Patients undergo dynamic contrast-enhanced (DCE) MRI, diffusion-weighted (DW) MRI, and magnetic resonance (MR) spectroscopy at baseline, 2-2.5 weeks, 4-5 weeks, and 1 month following radiation therapy completion, and fludeoxyglucose F 18 (FDG) PET/computed tomography (CT) at baseline, 2-2.5 weeks, and 4-5 weeks.

After completion of study, patients are followed up at least every 3-6 months for 5 years.

Eligibility criteria: Inclusion Criteria:

* Patients must have histologically confirmed stage IB2-IVA epithelial carcinoma of the cervix, including squamous cell, adeno-, and undifferentiated carcinoma, and excluding small cell/neuroendocrine carcinoma, who will undergo radiation therapy for cervical cancer with curative intent
* Surgical staging with retroperitoneal staging and lymphadenectomy is permitted
* Patients who will undergo standard radiation therapy with concurrent cisplatin-based chemotherapy for cervical cancer
* Patients with no prior radiation therapy to the pelvis
* Patients with no contra-indications to magnetic resonance (MR) imaging
* Patients must have adequate renal function: glomerular filtration rate (GFR) \> 30 mL/min/1.73 m\^2; for the test-retest sub-study MRI, patients must have a GFR of \> 60 mL/min/1.73m\^2
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Patients with small cell/neuroendocrine cervical carcinoma
* Patients who have received any prior pelvic radiation therapy in the area of the tumor that precludes the delivery of a curative dose of pelvic radiation
* Medical contraindication to MR imaging (e.g. pacemakers, metallic implants, aneurysm clips, known contrast allergy to gadolinium contrast, pregnancy, nursing mothers, weight greater than 350 pounds, GFR \< 30)
* Major medical or psychiatric illness that, in the investigator's opinion, would prevent completion of treatment, completion of the study protocol, or interfere with follow-up
* Life expectancy of less than 6 months

Primary outcomes:
measure: Disease-free survival
timeFrame: Up to 5 years
measure: Distant metastatic rate
timeFrame: Up to 5 years
measure: Local control
timeFrame: Up to 5 years
measure: Predictive power of the MRI and PET/CT parameters
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Miller School of Medicine-Sylvester Cancer Center
state: Florida
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
city: Hong Kong
country: Hong Kong
facility: University of Hong Kong
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Simon Lo
role: PRINCIPAL_INVESTIGATOR
References: