Skip to content

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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00890617
Enrollment
9
Registered
2009-04-30
Start date
2009-03-31
Completion date
2021-05-31
Last updated
2022-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Metastatic Cancer

Keywords

lung metastases, stage I non-small cell lung cancer

Brief summary

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.

Detailed description

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.

Interventions

PROCEDURECryotherapy (PTC)

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

DRUGPrednisone

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

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Barbara Ann Karmanos Cancer Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
The Number of Patients With a Response (Complete Response and Partial Response)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

MeasureTime frameDescription
The Number of Patients With a Pathologic Response6 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Prednisone & Cryotherapy
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 Cryotherapy (PTC): CT-guided PTC with the intent to eradicate the entire tumor(s). Prednisone: 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
9
Total9

Baseline characteristics

CharacteristicPrednisone & Cryotherapy
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
5 Participants
Age, Categorical
Between 18 and 65 years
4 Participants
Age, Continuous65.78 years
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
5 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
4 Participants
Region of Enrollment
United States
9 Participants
Sex: Female, Male
Female
2 Participants
Sex: Female, Male
Male
7 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
2 / 9
other
Total, other adverse events
9 / 9
serious
Total, serious adverse events
2 / 9

Outcome results

Primary

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

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).

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Prednisone & CryotherapyThe Number of Patients With a Response (Complete Response and Partial Response)8 Participants
Secondary

The Number of Patients With a Pathologic Response

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.

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

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Prednisone & CryotherapyThe Number of Patients With a Pathologic Responsemacroscopic residual viable tumor1 Participants
Prednisone & CryotherapyThe Number of Patients With a Pathologic Responsemicroscopic foci of viable tumor2 Participants
Prednisone & CryotherapyThe Number of Patients With a Pathologic Responseno microscopic viable tumor6 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026