Phase II Trial of 64Cu-ATSM PET/CT in Cervical Cancer
18 Years
N/A
Female
Cervical Cancer
Trial Information
Phase II Trial of 64Cu-ATSM PET/CT in Cervical Cancer
OBJECTIVES:
Primary
- To define the role of pre-therapy ^64Cu-labeled
diacetyl-bis(N4-methylthiosemicarbazone) (copper Cu 64-ATSM) in predicting prognosis
and determining the behavior of an invasive squamous cell cervical cancer in patients
with newly-diagnosed stage IB2-IVA cervical squamous cell carcinoma.
- To determine whether higher copper Cu 64-ATSM uptake is associated with lower
progression-free survival of these patients after chemoradiotherapy.
Secondary
- To determine if higher copper Cu 64-ATSM uptake is associated with lower overall
survival of these patients.
- To determine if higher copper Cu 64-ATSM uptake is associated with earlier primary
cervical tumor recurrence and a higher rate of development of distant metastatic
disease in these patients.
- To determine if higher copper Cu 64-ATSM uptake is associated with a lower frequency of
complete metabolic response on FDG-PET/CT scan performed 3 months after completion of
radiotherapy and chemotherapy.
- To estimate the accuracy of copper Cu 64-ATSM uptake as a predictor of progression-free
survival, overall survival, primary tumor recurrence, and future development of distant
metastatic disease in these patients.
- To evaluate the performance of copper Cu 64-ATSM uptake as a predictor of lymph node
metastasis at study entry.
- To evaluate whether copper Cu 64-ATSM uptake correlates with tumor volume at study
entry.
- To examine the relationship between tumor uptake of copper Cu 64-ATSM and other markers
of tumor hypoxia, including VEGF, GLUT-1, CA-IX, and OPN.
- To compare the predictive ability of pre-therapy copper Cu 64-ATSM-PET to that of
post-therapy FDG-PET/CT scan.
- To assess whether pre-therapy FDG-PET/CT findings are predictive of progression-free
survival.
OUTLINE: This is a multicenter study.
Patients receive copper Cu 64-ATSM IV and undergo PET/CT scan over 30 minutes 30-40 minutes
later. Within 4 weeks after copper Cu 64-ATSM-PET/CT scan, patients begin planned concurrent
standard of care chemoradiotherapy comprising 6 weeks of radiotherapy (external beam and
brachytherapy)and weekly cisplatin administration per NCCN guidelines. Patients then undergo
FDG-PET/CT scan 3 months after completion of chemoradiotherapy.
Tissue samples from previously collected cervical biopsy (obtained for diagnosis) are used
for detecting hypoxic markers by immunohistochemistry analysis.
After completion of study intervention, patients are followed for every 3 months for 2 years
and then every 6 months for 1 year.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed primary invasive cervical squamous cell carcinoma
- Newly diagnosed disease
- Stage IB2 - IVA disease based on FIGO staging system
- Plan to receive standard of care treatment with concurrent cisplatin and radiation
therapy (external beam and brachytherapy) per NCCN guidelines
- Must be scheduled to receive 6 weekly courses of cisplatin
- Meets 1 of the following criteria:
- Pelvic nodal (or no nodal) disease only by FDG-PET/CT scan within 4 weeks of
enrollment
- Para-aortic nodal metastasis by FDG-PET/CT scan within 4 weeks of enrollment,
and patient will undergo radiotherapy to para-aortic nodes
- FDG-PET/CT scan at baseline if not meeting any of the above criteria
- No stage IVB disease (distant metastases or supraclavicular metastasis) confirmed by
FDG-PET/CT scan
- No recurrent invasive carcinoma of the uterine cervix regardless of previous
treatment
- No know metastases to lungs, supraclavicular lymph nodes, or other organs outside of
the pelvis or abdominal lymph nodes at time of diagnosis
PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to lie flat for the duration of the PET/CT scan
- No septicemia or severe infection
- No uncontrolled or poorly controlled diabetes
- No circumstances that would prevent completion of imaging studies or required
clinical follow-up
- No other prior or concurrent invasive malignancies, with the exception of
non-melanoma skin cancer, within the past 5 years
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior pelvic or abdominal lymphadenectomy
- No prior pelvic radiation therapy
- No previous cancer treatment contraindicates this protocol therapy
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Relationship between copper Cu 64-ATSM uptake in the primary tumor and progression-free survival after chemoradiotherapy
Outcome Time Frame:
Three years
Safety Issue:
No
Principal Investigator
Farrokh Dehdashti, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Mallinckrodt Institute of Radiology at Washington University Medical Center
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000624407
NCT ID:
NCT00794339
Start Date:
July 2009
Completion Date:
Related Keywords:
- Cervical Cancer
- cervical squamous cell carcinoma
- stage IIB cervical cancer
- stage III cervical cancer
- stage IV cervical cancer
- stage IVA cervical cancer
- stage IB cervical cancer
- stage IIA cervical cancer
- Uterine Cervical Neoplasms
- Disease Progression
Name | Location |
|---|---|
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
