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Advanced Malignant MesotheliomaNCT01325753

Cryotherapy in Treating Patients With Lung Cancer That Has Spread to the Other Lung or Parts of the Body

A study testing cryotherapy and quality-of-life assessment in people with Advanced Malignant Mesothelioma and Extensive Stage Small Cell Lung Cancer, run by Wake Forest University Health Sciences.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This pilot clinical trial studies the side effects of cryotherapy (cryoablation [CA]) in treating patients with lung cancer. Cryotherapy kills cancer cells by freezing them. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
cryotherapy and quality-of-life assessment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Mar 2011to Mar 2017
Phase
Interventional
Are there results?
None posted in the registry

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with American Joint Committee on Cancer (AJCC) seventh edition metastatic carcinoma or sarcoma involving the lungs or pleura.
  • Pathologic diagnosis of stage 4 cancer prior to enrollment by biopsy or on imaging with known (biopsied) primary disease
  • The target lesion is determined (by CT or magnetic resonance imaging [MRI] images) to be in a location where cryoablation is technically achievable based on the proximity of adjacent organs and structures
  • Maximum number of lesions per patient will be 5 total (a maximum of 3 on either the right or left side and 2 lesions on the respective contralateral side)
  • Of these, any lesion not treated with cryoablation will be planned to be treated with radiotherapy or radiofrequency ablation, such that all known active pulmonary disease is planned to be treated with a definitive local therapy
  • If treatment of both lungs is to occur by cryoablation, these treatments must be separated by at least one week
Show all 15Show fewer
  • The lesion(s) treated with cryoablation may be intrapulmonary or pleural and must be =< 3.5 cm in greatest dimension
  • All patients are required to have been evaluated either in consultation with a radiation oncologist or at least in a multi-disciplinary tumor conference to ensure that all local therapy options are appropriately considered for each patient
  • Performance Status 0-2 (Eastern Cooperative Oncology Group [ECOG]); Karnofsky Performance Scale >= 60
  • Life expectancy > 3 months
  • Clinically suitable for cryoablation procedure as determined by the treating physician
  • Platelet count > 50,000/mm^3 within 60 days prior to study registration
  • International normalized ratio (INR) < 1.5 within 60 days prior to study registration
  • Absolute neutrophil count (ANC) < 1000 within 21 days prior to study registration
  • A signed study specific consent form is required

Who cannot join

  • Primary lung cancer
  • Unable to lie flat or has respiratory distress at rest
  • Uncontrolled coagulopathy or bleeding disorders
  • Evidence of active systemic, pulmonary, or pericardial infection
  • Pregnant, nursing or wishes to become pregnant during the study
  • Debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment or follow up
  • Currently participating in other experimental studies that could affect the primary endpoint

About this study

Official title: A Pilot Study of Cryoablation for Patients With Oligometastatic Cancer Involving the Lung

This pilot clinical trial studies the side effects of cryotherapy (cryoablation [CA]) in treating patients with lung cancer. Cryotherapy kills cancer cells by freezing them.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Assess the initial safety of the CA for lung tumors less than or equal to 3.5 cm in size including acute toxicity (30 days).

SECONDARY OBJECTIVES:

  1. Estimate local control.

II. To assess physical function for this cohort of patients.

III. To evaluate the impact of treatment on generic and disease-specific quality of life.

IV. To obtain pilot data useful for the design of a subsequent phase II or randomized phase II trial.

  1. Evaluate changes in pulmonary function at 3 months.

OUTLINE:

Patients undergo computed tomography (CT)-guided CA

After completion of study treatment, patients are followed up at 1 week and 1, 3, 6, 12, 24, 36, 48, and 60 months.

Being tested
cryotherapy, quality-of-life assessment
Medical subject headings
Mesothelioma, Malignant, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma

What participants receive

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

  • cryotherapyProcedure or surgery

    Undergo CT-guided CA

  • quality-of-life assessmentProcedure or surgery

    Also called quality of life assessment

    Ancillary studies

Study groups in NCT01325753
Study groupRoleWhat they receive
Treatment (cryoablation)ExperimentalPatients undergo CT-guided CA.
Receives: Procedure: cryotherapy; Procedure: quality-of-life assessment

What is being measured

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

  1. Safety of interventional cryoablation to the lung

    Unexpected toxiticities or Grade 4 or 5 toxicities will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE).

    Measured: 6 months

Secondary outcomes (4)

  1. Local control measured by imaging

    Measure definitions:

    • Complete Response(tumor disappearance or less than 25% of original size)
    • Partial Response (greater than 30% decrease in the sum of the largest diameter of all targeted tumors)
    • stable Disease (less than 30% decrease in the sum of the largest diameter of all targeted tumors)
    • Local Failure (greater than 20% increase in the sum of the largest diameter of all targeted tumors)
    • Distant Failure (the appearance of distant cancer deposits consistent with metastatic spread of cancer outside the intended treatment area)

    Measured: At 1 year

  2. Changes in Physical function and quality of life

    Measured by ECOG and KPS performance status, the Short Form - 12v2 questionnarie and shory physical performance battery

    Measured: approximately 60 months

  3. Changes in pulmonary function

    Measure by pulmonary function test

    Measured: At 3 months

  4. Obtain pilot data useful for the design of a subsequent phase II or randomized phase II trial

    Measured: approximately 60 months

Timeline

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

  1. First posted30 Mar 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionMar 2013 (estimated)
  4. Study completionMar 2017 (estimated)

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01325753
Sponsor's protocol ID
IRB00015085
Other IDs
NCI-2011-00319, CCCWFU 62210
Status last verified
Jul 2018
First submitted
28 Mar 2011
Last updated
3 Jul 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing cryotherapy and quality-of-life assessment in people with Advanced Malignant Mesothelioma and Extensive Stage Small Cell Lung Cancer, run by Wake Forest University Health Sciences.

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 15 inclusion and 7 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: withdrawn, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Safety of interventional cryoablation to the lung (time frame: 6 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 NCT01325753.

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 3 Jul 2018.

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