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

Primary Purpose

Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Computed Tomography Perfusion Imaging

About this trial

This is an interventional diagnostic trial for Recurrent Fallopian Tube Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

ECOG-ACRIN Cancer Research Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (computed tomography perfusion imaging)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Objective Response Rate

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

Full Information

NCT ID

NCT03412630

First Posted

January 22, 2018

Last Updated

June 21, 2023

Sponsor

ECOG-ACRIN Cancer Research Group

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT03412630

Brief Title

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

Official Title

Perfusion CT to Predict Progression-Free Survival and Response Rate in Bevacizumab Treatment of Platinum-Resistant Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Peritoneal Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Terminated

Why Stopped

poor accrual

Study Start Date

December 13, 2018 (Actual)

Primary Completion Date

March 19, 2019 (Actual)

Study Completion Date

January 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ECOG-ACRIN Cancer Research Group

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Diagnostic (computed tomography perfusion imaging)

Arm Type

Experimental

Arm Description

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.

Intervention Type

Radiation

Intervention Name(s)

Computed Tomography Perfusion Imaging

Intervention Description

Undergo computed tomography perfusion imaging

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

Time Frame

Time to progression or death from the T1 scan, assessed up to 18 months

Secondary Outcome Measure Information:

Title

Objective Response Rate

Description

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

Time Frame

Up to 18 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susanna Lee

Organizational Affiliation

ECOG-ACRIN Cancer Research Group

Official's Role

Principal Investigator

Facility Information:

Facility Name

ECOG-ACRIN Cancer Research Group

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19103

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Only 1 participant was accrued. To comply with HIPAA requirements no data will be shared.

Learn more about this trial

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

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