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TerminatedNCT03412630Updated Nov 24, 2023Results posted

Perfusion CT in Predicting Outcomes in Ovarian, Fallopian, or Peritoneal Cancer With Bevacizumab

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

Why this study was terminated
poor accrual
Phase
Not applicable
Study type
Interventional
Enrollment
1
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Recurrent Fallopian Tube Carcinoma
  • Recurrent Ovarian Carcinoma
  • Recurrent Primary Peritoneal Carcinoma
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • REGISTRATION TO STEP 0
  • Patient must have epithelial ovarian, fallopian tube, or primary peritoneal cancer

    • Patients with non-epithelial tumors or tumors with low malignant potential are excluded
  • Patient must have suspected platinum-resistant disease (disease progression =\< 6 months of platinum therapy)
  • Patient must be expected to undergo therapy with bevacizumab in combination with paclitaxel, pegylated liposomal doxorubicin (PLD), or topotecan at recommended standard of care doses if suspected recurrence is confirmed with imaging
  • Patient must be able and willing to provide written informed consent
  • Patient must have a life expectancy of >= 3 months
  • Patient must have adequate bone marrow, coagulation, renal, and hepatic function
  • Patient must demonstrate an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Patient must not have undergone therapy with any anti-VEGF drug within previous 6 months
  • Patient must not have undergone major surgery or radiotherapy to the pelvis or abdomen within previous 4 weeks
  • Patients must not have known contraindications to bevacizumab, including but not limited to abdominal fistula, gastrointestinal (GI) perforation, intra-abdominal abscess, thrombotic or hemorrhagic disorders, uncontrolled hypertension or active clinically significant cardiovascular disease, non-healing wound, ulcer, or bone fracture within previous 4 weeks
  • Patient must not have untreated or symptomatic central nervous system (CNS) metastasis
  • Patient must not have another active (within past 3 years) or concurrent malignancy
  • Patient must not have contraindication to iodinated contrast
  • REGISTRATION TO STEP 1
  • Patient must be evaluable using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
  • Patient must have perfusion CT target lesion (e.g., >= 1 cm in both the long and short axis, at least one half of the tumor appears enhancing and solid on a contrast-enhanced scan or has an attenuation of >= 10 Hounsfield unit [HU] on the unenhanced CT scan) on a contrast-enhanced conventional CT
  • Conventional chest abdomen and pelvis CT images demonstrating recurrent tumor must be submitted within 21 days from acquisition to the American College of Radiology (ACR) Core Lab
  • Eligibility of a perfusion CT target lesion must be confirmed by the ACR Core Lab prior to study enrollment and the T0 perfusion CT scan
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    Diagnostic (computed tomography perfusion imaging)

    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

Interventions

  • RadiationComputed Tomography Perfusion Imaging

    Undergo computed tomography perfusion imaging

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Objective Response Rate

    Will be assessed by Response Evaluation Criteria in Solid Tumors version 1.1.

    Time frame: Up to 18 months

06

Results

Posted Sep 27, 2022

Participant flow

The first patient was accrued on December 13, 2018.

Participant flow — Overall Study
MilestoneDiagnostic (Computed Tomography Perfusion Imaging)
Started1
Completed1
Not completed0

Outcome measures

PrimaryProgression 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

No measurements were reported for this outcome.

SecondaryObjective Response Rate

Will be assessed by Response Evaluation Criteria in Solid Tumors version 1.1.

Time frame:
Up to 18 months

No measurements were reported for this outcome.

Adverse events

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.

Adverse event summary by group
GroupDeathsSeriousOther
Diagnostic (Computed Tomography Perfusion Imaging)0/1 (0%)0/1 (0%)0/1 (0%)

Baseline characteristics

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
Age, Continuous(years)Diagnostic (Computed Tomography Perfusion Imaging)
Sex: Female, Male
Sex: Female, Male(Participants)Diagnostic (Computed Tomography Perfusion Imaging)
Female0
Male0
Race (NIH/OMB)
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—
07

Study locations

1 site
  • ECOG-ACRIN Cancer Research Group
    Philadelphia, Pennsylvania 19103, United States
08

References and documents

Study documents

  • Study protocol · Jun 13, 2018
  • Informed consent form · Jun 13, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Only 1 participant was accrued. To comply with HIPAA requirements no data will be shared.

09

Registry details

Key details

Study ID
NCT03412630
Lead sponsor
ECOG-ACRIN Cancer Research Group
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jan 26, 2018
Start date
Dec 13, 2018
Primary completion
Mar 19, 2019
Completion
Jul 22, 2020
Results posted
Sep 27, 2022
Last update
Nov 24, 2023

Study contacts

Susanna Lee
principal investigator · ECOG-ACRIN Cancer Research Group

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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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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