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

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Cervical Cancer	Drug: 64Cu-ATSM; Radiation: FDG	Phase 2

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	73 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	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
Study Start Date :	July 2009
Estimated Primary Completion Date :	June 2017
Estimated Study Completion Date :	December 2017

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Copper ATSM; pre-therapy pelvic 64Cu-ATSM-PET/CT with Pre- and post- therapy FDG PET/CT	Drug: 64Cu-ATSM; Other Name: copper 64 Radiation: FDG; Other Name: fludeoxyglucose F 18

Outcome Measures

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Primary Outcome Measures :

1. Relationship between copper Cu 64-ATSM uptake in the primary tumor and progression-free survival after chemoradiotherapy [ Time Frame: Three years ]

Secondary Outcome Measures :

1. Relationship between copper Cu 64-ATSM uptake and overall survival [ Time Frame: Three years ]
2. Relationship between copper Cu 64-ATSM uptake and rates of local recurrence and development of distant metastasis [ Time Frame: Three years ]
3. Relationship between copper Cu 64-ATSM uptake and frequency of complete metabolic response [ Time Frame: Three years ]
4. 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 ]
5. Correlation between copper Cu 64-ATSM uptake and tumor volume at study entry and lymph node metastasis at diagnosis [ Time Frame: Two weeks ]
6. Relationship of copper Cu 64-ATSM uptake and markers of tumor hypoxia, including VEGF, GLUT-1, CA-IX, and OPN [ Time Frame: Three years ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, California
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110

Sponsors and Collaborators

American College of Radiology Imaging Network

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Farrokh Dehdashti, MD	Mallinckrodt Institute of Radiology at Washington University Medical Center
Study Chair:	David A. Mankoff, MD, PhD	University of Washington

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

National Cancer Institute's Clinical trial database 

For additional information on ACRIN 6682, visit ACRIN.ORG. 

Responsible Party:	American College of Radiology Imaging Network
ClinicalTrials.gov Identifier:	NCT00794339 History of Changes
Other Study ID Numbers:	CDR0000624407; ACRIN-6682 ( Other Grant/Funding Number: ACRIN Foundation ); U01CA080098 ( U.S. NIH Grant/Contract ); U01CA079778 ( U.S. NIH Grant/Contract )
First Posted:	November 20, 2008
Last Update Posted:	March 20, 2017
Last Verified:	March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	See ACRIN data Sharing Policy https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx

Keywords provided by American College of Radiology Imaging Network:

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

Additional relevant MeSH terms:

Uterine Cervical Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female	Copper; Fluorodeoxyglucose F18; Trace Elements; Micronutrients; Growth Substances; Physiological Effects of Drugs; Radiopharmaceuticals; Molecular Mechanisms of Pharmacological Action