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Completed

NCT Number: NCT00002624

Video-Assisted Surgery Followed by Radiation Therapy in Treating Patients With Stage I Non-small Cell Lung Cancer and Poor Heart and Lung Function

RATIONALE: Video-assisted surgery followed by radiation therapy may be an effective treatment in patients whose poor heart and lung function make them high risk for standard surgery.

PURPOSE: Phase II trial to study the effectiveness of video-assisted surgery followed by radiation therapy in treating patients with stage I non-small cell lung cancer and poor heart and lung function.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Westmead Hospital, Westmead, New South Wales, Australia

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About this study

OBJECTIVES:

  • Determine the feasibility of video-assisted thoracoscopic wedge resection (VAR) followed by radiotherapy in patients with stage I non-small cell lung cancer and cardiopulmonary dysfunction.
  • Determine the incidence of locoregional recurrence in patients treated with this regimen.
  • Determine the overall and disease-free survival in patients treated with this regimen.
  • Determine the technical feasibility of ipsilateral lymph node sampling and complete resection with VAR in these patients.
  • Determine the incidence of conversion to open thoracotomy in these patients.
  • Determine the short- and long-term complications associated with VAR in these patients.
  • Determine the toxicity of adjuvant radiotherapy after VAR in these patients.

OUTLINE: This is a multicenter study.

Patients undergo video-assisted thoracoscopic wedge resection. Surgeons attempt sampling and identification of all ipsilateral, mediastinal, and hilar lymph nodes. When accessible, lobar lymph nodes must also be sampled. If the tumor margins are positive, further resection of the margins must be attempted. Open thoracotomy may be required for technical reasons.

Who can participate

Healthy volunteers accepted: No

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

DISEASE CHARACTERISTICS:

  • Known or suspected, single, peripheral, stage T1 N0 M0 lung tumor
  • Tumor must not be identifiable by bronchoscopy
  • Bronchoscopically visible cancer or bronchial distortions considered related to tumor
  • Positive cytology by bronchoscopy allowed if no gross abnormality visible
  • Mediastinoscopy required for nodes greater than 1 cm
  • No pleural effusions
  • No metastatic or N2 disease on CT scan
  • Lesion must be accessible for video-assisted thoracoscopic wedge resection
  • High cardiopulmonary risk for thoracotomy with at least 1 of the following criteria:
  • FEV1 less than 40% predicted
  • DLCO less than 50% predicted
  • Supplemental oxygen requirement
  • Chronic PaCO2 greater than 45 mm Hg
  • Maximum oxygen consumption (VO2 max) less than 15 mL/kg/min
  • Patients who appear at high risk for non-pulmonary reasons (e.g., patients who are elderly or with renal or cardiac failure) may be eligible only if VO2 max or other criteria above are met
  • Eligible for radiotherapy after completion of wedge resection if histologic documentation of non-small cell lung cancer, including any of the following subtypes:
  • Squamous cell carcinoma
  • Adenocarcinoma
  • Bronchoalveolar cell
  • Large cell anaplastic carcinoma
  • Cytology from bronchial washings and transthoracic needle aspiration not acceptable

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • 0-2

Other:

  • No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix
  • Weight loss no greater than 10% within the past 6 months

PRIOR CONCURRENT THERAPY:

Radiotherapy

  • No prior thoracic irradiation

Treatment and study plan

adjuvant therapy

Procedure

diagnostic thoracoscopy

Procedure

therapeutic thoracoscopy

Procedure

video-assisted surgery

Procedure

radiation therapy

Radiation

Primary outcomes

  1. Determine the feasibility of video-assisted thoracoscopic wedge resection (VAR)

    Time frame: Up to 10 years

  2. Determine the incidence of locoregional recurrence in patients treated with this regimen

    Time frame: Up to 10 years

  3. Determine the overall and disease-free survival

    Time frame: Up to 10 years

  4. Determine the short- and long-term complications associated with VAR in these patients

    Time frame: Up to 10 years

  5. Determine the technical feasibility of ipsilateral lymph node sampling and complete resection with VAR in these patients

    Time frame: Up to 10 years

  6. Determine the toxicity of adjuvant radiotherapy after VAR in these patients

    Time frame: Up to 10 years

Sponsors and collaborators

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

VIDEO ASSISTED WEDGE RESECTION (VAR) AND RADIOTHERAPY FOR HIGH RISK T1 NON-SMALL CELL LUNG CANCER: A PHASE II STUDY

Important dates

Study start
1994
Primary completion
2005
Study completion
2005
First posted
Jan 27, 2003
Registry last updated
Jul 14, 2016

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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