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Percutaneous Thoracic Cryotherapy (PTC) for Inoperable Primary Lung Cancer and Metastatic Management

18 Years
Open (Enrolling)
Lung Cancer, Metastatic Cancer

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Trial Information

Percutaneous Thoracic Cryotherapy (PTC) for Inoperable Primary Lung Cancer and Metastatic Management


- 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

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.

Inclusion Criteria


- 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

- No other widespread metastases evident (e.g., multiple hepatic or brain

- 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


- 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


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Local and distant failure rates by CT scan at 3, 6, and 12 months

Safety Issue:


Principal Investigator

Peter J. Littrup, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute



Study ID:




Start Date:

November 2005

Completion Date:

Related Keywords:

  • Lung Cancer
  • Metastatic Cancer
  • 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
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201