N/A N=40 Treatment

Cryotherapy in Treating Patients With Primary Lung Cancer or Lung Metastases That Cannot Be Removed By Surgery

Lung Cancer · Metastatic Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00303901 ↗

Enrolled (actual)

Serious AEs

22.5%

Results posted

Feb 2015

Primary outcome: Primary: Local Failure Rates by CT Scan — 15 % of participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: cryosurgery (Procedure); positron emission tomography (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Barbara Ann Karmanos Cancer Institute
Primary completion: Jul 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Local Failure Rates by CT Scan	15	—
PRIMARY Distant Failure Rate	52.5	—
SECONDARY Rate of Complications and Adverse Reactions by Occurrences of Toxicities	1; 3; 2; 1; 1; 1	—
SECONDARY Correlate Procedural Parameters and Follow-up Imaging Parameters	—	—
SECONDARY Point and Exact Confidence Interval Estimates of Patients Who Undergo Multiple Cryotherapy Procedures	—	—

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 removed by surgery.

Eligibility Criteria

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00303901). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.