An interventional study of Computed Tomography Perfusion Imaging in Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma and Recurrent Primary Peritoneal Carcinoma, sponsored by ECOG-ACRIN Cancer Research Group. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-24.
Sponsored by ECOG-ACRIN Cancer Research Group · Not applicable, Interventional, and Diagnostic
This phase II trial studies how well computed tomography perfusion imaging works in predicting outcomes in patients with ovarian, fallopian tube, or primary peritoneal cancer who are receiving bevacizumab. Computed tomography perfusion imaging monitors the effects of the drug treatment on the blood flow to the tumor, and may help to predict whether a certain drug therapy is likely be successful in a patient with ovarian, fallopian tube, or primary peritoneal cancer.
PRIMARY OBJECTIVES:
I. To evaluate whether those patients with an increase in perfusion computed tomography (CT) tumor blood flow (BF) from T0 to T1 demonstrate poorer progression-free survival (PFS) compared to those patients with a decrease in BF from T0 to T1, among platinum-resistant, recurrent ovarian cancer patients treated with bevacizumab.
SECONDARY OBJECTIVES:
I. To evaluate whether change in perfusion CT tumor BF from T0 to T1, as a continuous variable, is associated with PFS.
II. To evaluate whether changes in perfusion CT tumor blood volume (BV) or permeability surface product area (PS) from T0 to T1 are associated with PFS.
III. To evaluate whether changes in perfusion CT tumor BF, BV, or PS from T0 to T1 are associated with response rate according to the standard anatomic response evaluation criteria (RECIST 1.1).
IV. To identify which combination of perfusion CT parameters, including tumor BF, BV, and PS, can serve to optimally distinguish patients in terms of PFS outcome.
V. To evaluate whether the association between change in perfusion CT parameters and treatment outcome (PFS or tumor response) is stable when analyzed with various commercially-available post-processing software.
TERTIARY OBJECTIVES:
I. In the subset of patients with multiple, eligible perfusion target lesions within the CT imaging volume, describe the variability of perfusion CT changes across different lesions within the same patient, and evaluate the impact of multiple target lesions on the association between change in perfusion CT parameters and PFS.
II. In a subset of patients, measure the reliability of perfusion CT parameters by analyzing the same perfusion imaging dataset using different readers and different post-processing software.
OUTLINE:
Patients undergo computed tomography perfusion imaging at baseline and on day 15 after initiation of standard of care bevacizumab treatment and before the second dose.
After completion of study, patients are followed up every 8 weeks for up to 18 months.
Inclusion Criteria:
Patient must have epithelial ovarian, fallopian tube, or primary peritoneal cancer
Patients undergo computed tomography perfusion imaging at baseline and on day 15 after initiation of standard of care bevacizumab treatment and before the second dose.
Radiation: Computed Tomography Perfusion Imaging
Undergo computed tomography perfusion imaging
Progression Free Survival (PFS)
The PFS of patients with increased tumor blood flow (BF) from T0 to T1 will be compared with that of patients with decreased tumor BF from T0 to T1. Kaplan-Meier survival curves will be generated, and a two-sided log-rank test will be used to compare PFS between the two groups.
Time frame: Time to progression or death from the T1 scan, assessed up to 18 months
Objective Response Rate
Will be assessed by Response Evaluation Criteria in Solid Tumors version 1.1.
Time frame: Up to 18 months
The first patient was accrued on December 13, 2018.
| Milestone | Diagnostic (Computed Tomography Perfusion Imaging) |
|---|---|
| Started | 1 |
| Completed | 1 |
| Not completed | 0 |
The PFS of patients with increased tumor blood flow (BF) from T0 to T1 will be compared with that of patients with decreased tumor BF from T0 to T1. Kaplan-Meier survival curves will be generated, and a two-sided log-rank test will be used to compare PFS between the two groups.
No measurements were reported for this outcome.
Will be assessed by Response Evaluation Criteria in Solid Tumors version 1.1.
No measurements were reported for this outcome.
Collected over Adverse events were assessed at baseline imaging, and before second dose of Tx, up to 30 days... Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Diagnostic (Computed Tomography Perfusion Imaging) | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
1 participant was accrued and available for analysis. This is insufficient for any meaningful statistical analysis and all results have been suppressed to comply with HIPAA
| Age, Continuous(years) | Diagnostic (Computed Tomography Perfusion Imaging) |
|---|
| Sex: Female, Male(Participants) | Diagnostic (Computed Tomography Perfusion Imaging) |
|---|---|
| Female | 0 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | Diagnostic (Computed Tomography Perfusion Imaging) |
|---|---|
| American Indian or Alaska Native | — |
| Asian | — |
| Native Hawaiian or Other Pacific Islander | — |
| Black or African American | — |
| White | — |
| More than one race | — |
| Unknown or Not Reported | — |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Only 1 participant was accrued. To comply with HIPAA requirements no data will be shared.
This study is terminated, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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ECOG-ACRIN Cancer Research Group