Recurrent Fallopian Tube CarcinomaNCT03412630

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

A study testing Computed Tomography Perfusion Imaging in people with Recurrent Fallopian Tube Carcinoma and Recurrent Ovarian Carcinoma, run by ECOG-ACRIN Cancer Research Group at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma
What is being tested?: Computed Tomography Perfusion Imaging
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 1 siteUnited States
Study dates: 13 Dec 2018to 22 Jul 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

ECOG-ACRIN Cancer Research Group
Philadelphia, Pennsylvania, 19103

Other trials in United States

About this study

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

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:

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:

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.

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:

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.

Conditions: Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma
Being tested: Computed Tomography Perfusion Imaging
Medical subject headings: Fallopian Tube Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Computed Tomography Perfusion ImagingRadiation
Undergo computed tomography perfusion imaging

Study groups in NCT03412630
Study group	Role	What they receive
Diagnostic (computed tomography perfusion imaging)	Experimental	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. Receives: Radiation: Computed Tomography Perfusion Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Dec 201822 Jul 2020

First posted26 Jan 2018
Study start13 Dec 2018
Primary completion19 Mar 2019
Study completion22 Jul 2020

Why it stopped: poor accrual

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Recurrent Fallopian Tube CarcinomaStudies of the same condition, open and under way.
More trials run by ECOG-ACRIN Cancer Research GroupThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03412630
Sponsor's protocol ID: EAE161
Other IDs: NCI-2017-01029, EAE161, EAE161, U10CA180820
Status last verified: Nov 2023
First submitted: 22 Jan 2018
Last updated: 24 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: Only 1 participant was accrued. To comply with HIPAA requirements no data will be shared.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
IGFBP-2 Vaccine to Prevent Ovarian Cancer Progression in Patients With Serologic Detection of Recurrence
Fallopian Tube Carcinoma, Ovarian Carcinoma
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
RecruitingPhase 1/2
A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003).
Ovarian Cancer Recurrent
Active, not recruitingPhase 2/3
Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Fallopian Tube High Grade Serous Adenocarcinoma, Ovarian High Grade Serous Adenocarcinoma
Active, not recruitingPhase 1
Surgery and Chemotherapy With or Without Chemotherapy After Surgery in Treating Patients With Ovarian, Fallopian Tube, Uterine, or Peritoneal Cancer
FIGO Stage IVA Ovarian Cancer, FIGO Stage IVB Ovarian Cancer

All Recurrent Fallopian Tube Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03412630
Acronym / sponsor ID: EAE161
Conditions: Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma
Study type: Interventional
Recruitment status: TerminatedReason stopped: poor accrual
Enrolment: 1 participants (actual)
Lead sponsor: ECOG-ACRIN Cancer Research GroupResearch network
Collaborators: National Cancer Institute (NCI)
Study start: 13 Dec 2018 (actual)
Primary completion: 19 Mar 2019 (actual)
Study completion: 22 Jul 2020 (actual)
First posted: 26 Jan 2018 (actual)
Results: Posted 27 Sep 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

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:

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.

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:

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.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Diagnostic (computed tomography perfusion imaging)	Experimental	Radiation: Computed Tomography Perfusion ImagingPatients undergo computed tomography perfusion imaging at baseline and on day 15 after initiation of standard of care bevacizumab treatment and before the second dose.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (20 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Computed Tomography Perfusion ImagingUndergo computed tomography perfusion imaging	Radiation	Diagnostic (computed tomography perfusion imaging)

Primary outcome

Progression Free Survival (PFS)
Time frame: Time to progression or death from the T1 scan, assessed up to 18 months
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.

1 secondary outcome

Objective Response Rate
Time frame: Up to 18 months

Results and safety

Results posted to the registry on 27 Sep 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Diagnostic (Computed Tomography Perfusion Imaging)	1	1

Primary outcome: Progression Free Survival (PFS)

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

Population analysed: Analysis not performed due to lack of data. Only 1 participant was accrued and available for analysis. This is insufficient for any meaningful statistical analysis and thus no analyses were performed. To comply with HIPAA requirements, all data and results for this participant been suppressed .

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were assessed at baseline imaging, and before second dose of Tx, up to 30 days... Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diagnostic (Computed Tomography Perfusion Imaging)	0 of 1 (0%)	0 of 1 (0%)	0 of 1

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Only 1 participant was accrued. To comply with HIPAA requirements no data will be shared.

Related trials for Recurrent Fallopian Tube Carcinoma

RecruitingPhase 2
IGFBP-2 Vaccine to Prevent Ovarian Cancer Progression in Patients With Serologic Detection of Recurrence
Fallopian Tube Carcinoma, Ovarian Carcinoma
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
RecruitingPhase 1/2
A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003).
Ovarian Cancer Recurrent
Active, not recruitingPhase 2/3
Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Fallopian Tube High Grade Serous Adenocarcinoma, Ovarian High Grade Serous Adenocarcinoma
Active, not recruitingPhase 1
Surgery and Chemotherapy With or Without Chemotherapy After Surgery in Treating Patients With Ovarian, Fallopian Tube, Uterine, or Peritoneal Cancer
FIGO Stage IVA Ovarian Cancer, FIGO Stage IVB Ovarian Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Susanna Lee principal investigator

ECOG-ACRIN Cancer Research Group

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Time to progression or death from the T1 scan, assessed up to 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03412630.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.