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
Conditions
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.
Interventions
PROCEDUREComputed Tomography
Undergo FDG PET/CT
PROCEDUREDiffusion Weighted Imaging
Undergo DW MRI
PROCEDUREDynamic Contrast-Enhanced Magnetic Resonance Imaging
Undergo DCE MRI
RADIATIONFludeoxyglucose F-18
Undergo FDG PET/CT
PROCEDUREMagnetic Resonance Spectroscopic Imaging
Undergo MR spectroscopy
PROCEDUREPositron Emission Tomography
Undergo FDG PET/CT
Sponsors
National Cancer Institute (NCI)
National Institutes of Health (NIH)
University of Washington
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival | Up to 5 years | — |
| Distant metastatic rate | Up to 5 years | — |
| Local control | Up to 5 years | Clinical/pelvic examination, pap smear, other standard of care investigations as indicated by clinical findings. |
| Predictive power of the MRI and PET/CT parameters | Up to 5 years | Hazard ratios will be calculated. Predictive power of the heterogeneity metrics will be compared and ranked with Federation of Gynecology and Obstetrics stage, lymph node status, histology, hemoglobin level, and tumor anatomic volumes. Multivariate predictive algorithms will be derived by synergizing the predictive power of imaging metrics and clinical prognosticators for clinical translation. |
Countries
Canada, Hong Kong, United States
Outcome results
None listed