Lung CancerNCT00303901
Cryotherapy in Treating Patients With Primary Lung Cancer or Lung Metastases That Cannot Be Removed By Surgery
A study testing cryosurgery and positron emission tomography in people with Lung Cancer and Metastatic Cancer, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
Trial summary
RATIONALE: Cryotherapy kills tumor cells by freezing them. This may be an effective treatment for primary lung cancer or lung metastases that cannot be removed by surgery. PURPOSE: This clinical trial is studying how well cryotherapy works in treating patients with primary lung cancer or lung metastases that cannot be… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lung Cancer, Metastatic Cancer
- What is being tested?
- cryosurgery and positron emission tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Jul 2011
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed malignant pulmonary neoplasm
- New lung lesion(s) with definitive clinical and imaging features of primary or metastatic disease allowed
- Imaging findings compatible with localized treatment failure after prior cryotherapy allowed
- Malignant pleural effusion allowed provided it is associated with a distinct measurable pulmonary mass amenable to cryotherapy
- Metastatic disease must meet all of the following criteria:
- Primary tumors have been resected or have been deemed controlled by other therapies
- No other widespread metastases evident (e.g., multiple hepatic or brain metastases)
- Each pulmonary mass must be amenable to CT-guided percutaneous cryotherapy approach
- No more than 5 targeted masses for study therapy
- Target mass defined as pulmonary, hilar, mediastinal, and/or chest wall mass > 1 cm, but < 10 cm in average diameter
- Unresectable disease by surgical consultation OR patient refused surgical options
- Nonenhanced and enhanced CT scan required within the past 6 weeks done at 4-5 mm increments with available soft tissue and mediastinal windows to assess size and extent of all thoracic tumors
- PET scan required within the past 6 months noting the correlation with the above CT locations, if not already obtained by a combined PET/CT scanner
PATIENT CHARACTERISTICS:
- Karnofsky performance status (PS) > 60-100% OR WHO/ECOG/Zubrod PS 0-2
- FEV_1 > 30% of predicted
- DLCO > 40% of predicted
- Platelet count ≥ 70,000/mm^3
- INR < 1.5
- No uncontrolled coagulopathy or bleeding diathesis
- Not pregnant or nursing
- Negative pregnancy test
- No serious medical illness, including any of the following:
- Uncontrolled congestive heart failure
- Uncontrolled angina
- Myocardial infarction
- Cerebrovascular event within 6 months prior to study entry
- No medical contraindication or potential problem that would preclude study compliance
PRIOR CONCURRENT THERAPY:
- At least 7 days since prior aspirin and aspirin-like medications
- At least 3 days since prior warfarin, clopidogrel bisulfate, or similar compounds
- No concurrent drugs causing bleeding tendencies (e.g., aspirin, warfarin, or clopidogrel bisulfate)
- No concurrent participation in other experimental studies
Trial locations and contacts
1 site in 1 country.
United States1 site
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
About this study
Official title: Percutaneous Thoracic Cryotherapy (PTC) for Inoperable Primary Lung Cancer and Metastatic Management
RATIONALE: Cryotherapy kills tumor cells by freezing them. This may be an effective treatment for primary lung cancer or lung metastases that cannot be removed by surgery.
PURPOSE: This clinical trial is studying how well cryotherapy works in treating patients with primary lung cancer or lung metastases that cannot be removed by surgery.
Read the detailed description
OBJECTIVES:
- Estimate the local and distant failure rates after percutaneous thoracic cryotherapy (PTC) in patients with unresectable primary lung cancer or lung metastases.
- Estimate rates of PTC complications and adverse reactions.
- Determine the correlations between procedural parameters and follow-up imaging parameters, with the latter being used as surrogates of local and/or distant treatment failure.
OUTLINE: Patients undergo CT-guided percutaneous thoracic cryotherapy over 2 hours under local or general anesthesia. Grouped cryoprobes are inserted into the tumor, utilizing a freeze-thaw-freeze cycle, creating cytotoxic temperatures (less than -20°C to -40°C) that encompass the entire anticipated tumor volume.
Patients undergo positron emission tomography at baseline and after cryotherapy to assess tumor standard uptake variable.
After completion of study treatment, patients are followed at 1, 3, 6 and 12 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
- Conditions
- Lung Cancer, Metastatic Cancer
- Being tested
- cryosurgery, positron emission tomography
- Keywords
- lung metastases, recurrent non-small cell lung cancer, recurrent small cell lung cancer, stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, extensive stage small cell lung cancer, limited stage small cell lung cancer, pulmonary carcinoid tumor
- Medical subject headings
- Lung Neoplasms, Neoplasm Metastasis, 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.
cryosurgeryProcedure or surgery
positron emission tomographyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| cryosurgery | Experimental | cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions. Receives: Procedure: cryosurgery; Procedure: positron emission tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Failure Rates by CT Scan
Local Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence
Measured: at 3, 6, and 12 months
Distant Failure Rate
Distant Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence
Measured: at 3, 6, and 12 months
Secondary outcomes (3)
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
Rate of complications and adverse reactions by occurrences of toxicities as measured by the number of participants with a given category of toxicity.
Measured: at 3, 6, and 12 months
Correlate Procedural Parameters and Follow-up Imaging Parameters
Measured: at 3, 6, and 12 months
Point and Exact Confidence Interval Estimates of Patients Who Undergo Multiple Cryotherapy Procedures
Measured: 12 months after the last patient was enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2006 (estimated)
- Study startNov 2005
- Primary completionJul 2011
- Study completionJul 2011
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 Lung CancerStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Peter John Littrup, Barbara Ann Karmanos Cancer Institute
- Investigators
- Peter J. Littrup, MD, Study chair, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00303901
- Sponsor's protocol ID
- CDR0000462091
- Other IDs
- P30CA022453, WSU-C-2975, WSU-0509002942
- Status last verified
- Jul 2020
- First submitted
- 15 Mar 2006
- Last updated
- 22 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Thoracic Cryotherapy (PTC) for Inoperable Primary Lung Cancer and Metastatic Management
- ClinicalTrials.gov ID
- NCT00303901
- Acronym / sponsor ID
- CDR0000462091
- Conditions
- Lung Cancer, Metastatic Cancer
- Keywords
- lung metastases, recurrent non-small cell lung cancer, recurrent small cell lung cancer, stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2005
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 17 Mar 2006 (estimated)
- Results
- Posted 23 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Cryotherapy kills tumor cells by freezing them. This may be an effective treatment for primary lung cancer or lung metastases that cannot be removed by surgery.
PURPOSE: This clinical trial is studying how well cryotherapy works in treating patients with primary lung cancer or lung metastases that cannot be removed by surgery.
Detailed description
OBJECTIVES:
- Estimate the local and distant failure rates after percutaneous thoracic cryotherapy (PTC) in patients with unresectable primary lung cancer or lung metastases.
- Estimate rates of PTC complications and adverse reactions.
- Determine the correlations between procedural parameters and follow-up imaging parameters, with the latter being used as surrogates of local and/or distant treatment failure.
OUTLINE: Patients undergo CT-guided percutaneous thoracic cryotherapy over 2 hours under local or general anesthesia. Grouped cryoprobes are inserted into the tumor, utilizing a freeze-thaw-freeze cycle, creating cytotoxic temperatures (less than -20°C to -40°C) that encompass the entire anticipated tumor volume.
Patients undergo positron emission tomography at baseline and after cryotherapy to assess tumor standard uptake variable.
After completion of study treatment, patients are followed at 1, 3, 6 and 12 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cryosurgery | Experimental | Procedure: cryosurgery, Procedure: positron emission tomographycryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| cryosurgery | Procedure or surgery | cryosurgery |
| positron emission tomography | Procedure or surgery | cryosurgery |
Primary outcome
Local Failure Rates by CT Scan
Time frame: at 3, 6, and 12 months
Local Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence
Distant Failure Rate
Time frame: at 3, 6, and 12 months
Distant Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence
3 secondary outcomes
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
Time frame: at 3, 6, and 12 months
Correlate Procedural Parameters and Follow-up Imaging Parameters
Time frame: at 3, 6, and 12 months
Point and Exact Confidence Interval Estimates of Patients Who Undergo Multiple Cryotherapy Procedures
Time frame: 12 months after the last patient was enrolled
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung 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.
Peter J. Littrup, MD study chair
Barbara Ann Karmanos Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cryosurgery and positron emission tomography in people with Lung Cancer and Metastatic Cancer, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 22 Jul 2020. 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 23 Feb 2015). 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?
Local Failure Rates by CT Scan (time frame: at 3, 6, and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2020.