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A Pilot Study of Percutaneous Cryotherapy as Treatment for Stage I Lung Cancer or Solitary Metastatic Lung Cancer

Phase 1
18 Years
Open (Enrolling)
Lung Cancer, Metastatic Cancer

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Trial Information

A Pilot Study of Percutaneous Cryotherapy as Treatment for Stage I Lung Cancer or Solitary Metastatic Lung Cancer



- Evaluate the histologic result of treating patients with primary stage I non-small cell
lung cancer or lung metastasis after neoadjuvant percutaneous cryotherapy (PTC).


- Provide a qualitative assessment of the histology from the ablation and tumor margins,
comparing histologic observations with imaging-enhancement patterns by CT or PET scan
before and after PTC.

OUTLINE: Patients undergo CT-guided percutaneous cryotherapy (PTC) over 2 hours.
Approximately 3 weeks after completion of PTC, patients undergo thoracotomy consisting of
lobectomy of the primary lung cancer or wedge resection with adequate margin for the
metastatic lesion, and mediastinal lymph node dissection.

Tissue samples from ablation and tumor margins are collected during thoracotomy and compared
with imaging-enhanced patterns of CT or PET scans taken at baseline and after PTC.

After completion of study therapy, patients are followed periodically for 6 months.

Inclusion Criteria


- Histologically or cytologically confirmed (by percutaneous transthoracic needle
biopsy or transbronchial biopsy) diagnosis of 1 the following:

- Non-small cell lung carcinoma

- Stage I disease

- Primary disease

- No primary lung metastatic disease, satellite lesions of the chest,
mediastinal lymph nodes > 1.5 cm, hepatic or adrenal masses by the PET scan
or the CT scan

- Metastatic cancer to the lung

- Must have a definitive cancer diagnosis with the primary tumor under local
control and no metastatic disease other than to the lung

- Solitary or multiple (≤ 3) peripheral lung lesions

- No chemotherapy since the new metastatic lesion appeared

- Measurable disease, defined as 1 lesion unidimensionally measured ≤ 3.0 cm by
conventional CT scan techniques

- Must be registered with the Clinical Trials office at the Karmanos Cancer
Center/Wayne State University

- Must be a candidate for a thoracotomy

- No evidence of cerebral disease or metastatic disease of the brain


- Neutrophil count > 1,500/mm^3

- Platelet count > 75,000/mm^3

- PT and PTT normal

- FEV_1 > 1.0 L/sec

- Diffusing capacity ≥ 30%

- Not pregnant or nursing

- No other uncontrolled or concurrent illnesses including, but not limited to, any of
the following conditions:

- Active infection

- Heart failure

- Unstable angina

- Cardiac dysrhythmia

- Psychiatric illness or a social situation that would limit compliance with the
study requirements


- See Disease Characteristics

- No prior radiation therapy or chemotherapy for these particular tumors

- No concurrent aspirin or other platelet-inhibiting drugs (e.g., coumadin or heparin)

- No other concurrent experimental studies

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (complete response and partial response)

Outcome Time Frame:

3 weeks post-Percutaneous Cryotherapy (PTC)

Safety Issue:


Principal Investigator

Frank A. Baciewicz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute


United States: Federal Government

Study ID:




Start Date:

March 2009

Completion Date:

Related Keywords:

  • Lung Cancer
  • Metastatic Cancer
  • lung metastases
  • stage I non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201