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Phase II Trial of 64Cu-ATSM PET/CT in Cervical Cancer (ACRIN6682)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
American College of Radiology Imaging Network
ClinicalTrials.gov Identifier:
NCT00794339
First received: November 19, 2008
Last updated: March 16, 2017
Last verified: March 2017

November 19, 2008
March 16, 2017
July 2009
June 2017   (Final data collection date for primary outcome measure)
Relationship between copper Cu 64-ATSM uptake in the primary tumor and progression-free survival after chemoradiotherapy [ Time Frame: Three years ]
Relationship between copper Cu 64-ATSM uptake in the primary tumor and progression-free survival after chemoradiotherapy
Complete list of historical versions of study NCT00794339 on ClinicalTrials.gov Archive Site
  • Relationship between copper Cu 64-ATSM uptake and overall survival [ Time Frame: Three years ]
  • Relationship between copper Cu 64-ATSM uptake and rates of local recurrence and development of distant metastasis [ Time Frame: Three years ]
  • Relationship between copper Cu 64-ATSM uptake and frequency of complete metabolic response [ Time Frame: Three years ]
  • 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 [ Time Frame: Three years ]
  • Correlation between copper Cu 64-ATSM uptake and tumor volume at study entry and lymph node metastasis at diagnosis [ Time Frame: Two weeks ]
  • Relationship of copper Cu 64-ATSM uptake and markers of tumor hypoxia, including VEGF, GLUT-1, CA-IX, and OPN [ Time Frame: Three years ]
  • Relationship between copper Cu 64-ATSM uptake and overall survival
  • Relationship between copper Cu 64-ATSM uptake and rates of local recurrence and development of distant metastasis
  • Relationship between copper Cu 64-ATSM uptake and frequency of complete metabolic response
  • 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
  • Correlation between copper Cu 64-ATSM uptake and tumor volume at study entry and lymph node metastasis at diagnosis
  • Relationship of copper Cu 64-ATSM uptake and markers of tumor hypoxia, including VEGF, GLUT-1, CA-IX, and OPN
Not Provided
Not Provided
 
Phase II Trial of 64Cu-ATSM PET/CT in Cervical Cancer
Copper Cu 64-ATSM and PET/CT Scan in Predicting Disease Progression in Patients With Newly-Diagnosed Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer Who Are Undergoing Chemoradiotherapy Per NCCN Guidelines

RATIONALE: Diagnostic procedures, such as copper Cu 64-ATSM PET/CT scans, may help doctors predict how patients will respond to treatment.

PURPOSE: This phase II trial is studying how well copper Cu 64-ATSM PET/CT scans work in predicting disease progression in patients undergoing standard of care treatment with cisplatin and radiation therapy (external beam and brachytherapy) per NCCN guidelines for newly-diagnosed stage IB, stage II, stage III, or stage IVA 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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Diagnostic
Cervical Cancer
  • Drug: 64Cu-ATSM
    Other Name: copper 64
  • Radiation: FDG
    Other Name: fludeoxyglucose F 18
Experimental: Copper ATSM
pre-therapy pelvic 64Cu-ATSM-PET/CT with Pre- and post- therapy FDG PET/CT
Interventions:
  • Drug: 64Cu-ATSM
  • Radiation: FDG
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
73
December 2017
June 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00794339
CDR0000624407
ACRIN-6682 ( Other Grant/Funding Number: ACRIN Foundation )
U01CA080098 ( US NIH Grant/Contract Award Number )
U01CA079778 ( US NIH Grant/Contract Award Number )
Yes
Not Provided
Yes
See ACRIN data Sharing Policy https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx
American College of Radiology Imaging Network
American College of Radiology Imaging Network
National Cancer Institute (NCI)
Principal Investigator: Farrokh Dehdashti, MD Mallinckrodt Institute of Radiology at Washington University Medical Center
Study Chair: David A. Mankoff, MD, PhD University of Washington
American College of Radiology Imaging Network
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP