Clinical trial · Interventional
Video-Assisted Surgery Followed by Radiation Therapy in Treating Patients With Stage I Non-small Cell Lung Cancer and Poor Heart and Lung Function
VIDEO ASSISTED WEDGE RESECTION (VAR) AND RADIOTHERAPY FOR HIGH RISK T1 NON-SMALL CELL LUNG CANCER: A PHASE II STUDY
NCT00002624CI-TRIAL-00023092completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| diagnostic thoracoscopy | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
| therapeutic thoracoscopy | Procedure | — | UNRESOLVED |
| video-assisted surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiotherapy + surgery
- description
- Patients begin radiotherapy 2-8 weeks postoperatively. Patients with complete resection undergo radiotherapy 5 days a week for 5.6 weeks. Patients with incomplete resection undergo radiotherapy 5 days a week for 6.6 weeks. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
- interventionNames
- Procedure: adjuvant therapy
- Procedure: diagnostic thoracoscopy
- Procedure: therapeutic thoracoscopy
- Procedure: video-assisted surgery
- Radiation: radiation therapy
Primary outcomes (6)
- measure
- Determine the feasibility of video-assisted thoracoscopic wedge resection (VAR)
- timeFrame
- Up to 10 years
- measure
- Determine the incidence of locoregional recurrence in patients treated with this regimen
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 irradiationReferences
Publications (2)
- RESULTShennib H, Bogart J, Herndon JE, Kohman L, Keenan R, Green M, Sugarbaker D; Cancer and Leukemia Group B; Eastern Cooperative Oncology Group. Video-assisted wedge resection and local radiotherapy for peripheral lung cancer in high-risk patients: the Cancer and Leukemia Group B (CALGB) 9335, a phase II, multi-institutional cooperative group study. J Thorac Cardiovasc Surg. 2005 Apr;129(4):813-8. doi: 10.1016/j.jtcvs.2004.05.011. PMID 15821648
- RESULTBogart J, Shennib H, Kohman L, et al.: Radiotherapy following thorascopic wedge resection (TWR) of T1 non-small cell lung cancer (NSCLC) in high risk patients: a Cancer and Leukemia Group B and Eastern Cooperative Oncology Group Phase II Trial. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A1907, 2000.