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Completed

NCT Number: NCT00890617

Cryotherapy in Treating Patients With Primary Stage I Non-Small Cell Lung Cancer or Lung Metastasis

RATIONALE: Cryotherapy kills tumor cells by freezing them. Giving cryotherapy before surgery may kill more tumor cells.

PURPOSE: This phase I trial is studying how well cryotherapy works in treating patients with primary stage I non-small cell lung cancer or lung metastasis.

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

About this study

OBJECTIVES:

Primary

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

Secondary

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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

Treatment and study plan

Cryotherapy (PTC)

Procedure

CT-guided PTC with the intent to eradicate the entire tumor(s).

Prednisone

Drug

Prednisone taken:

20mg BID on the day of the cryotherapy procedure 20mg BID on the day after the procedure 20mg BID two days after the procedure 20mg AM and 10mg PM three days after the procedure 10mg AM and 10mg PM four days after the procedure 10mg five days after the procedure 5mg six days after the procedure

Other names: Rayos, Sterapred

Primary outcomes

  1. The Number of Patients With a Response (Complete Response and Partial Response)

    Time frame: 3 weeks post-Percutaneous Cryotherapy (PTC)

    Treatment success was defined as > 75% of the resected ablated tissue showing no cancer on detailed histologic analysis. The primary statistical objective was to estimate the PCA success rate (p).

Secondary outcomes

  1. The Number of Patients With a Pathologic Response

    Time frame: 6 months post-Percutaneous Cryotherapy (PTC)

    Histology samples from anterior, posterior, superior, inferior, medial and lateral areas of the resected tumor will be compared to enhancement zones of the ablation margin for any residual cancer.

Sponsors and collaborators

Lead sponsor

Barbara Ann Karmanos Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2019
Study completion
2021
First posted
Apr 30, 2009
Registry last updated
Nov 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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