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

• Sponsor: Alliance for Clinical Trials in Oncology (Other)
• Overall Status: Completed
• CT.gov ID: NCT00002624
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 66
• Locations: 16
• Arm: 1
• Duration (Months): 128
• Patients Per Site: 4.1
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Procedure: adjuvant therapy; Procedure: diagnostic thoracoscopy; Procedure: therapeutic thoracoscopy; Procedure: video-assisted surgery; Radiation: radiation therapy	Phase 2

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: VIDEO ASSISTED WEDGE RESECTION (VAR) AND RADIOTHERAPY FOR HIGH RISK T1 NON-SMALL CELL LUNG CANCER: A PHASE II STUDY
• Study Start Date: Dec 1, 1994
• Actual Primary Completion Date: Apr 1, 2005
• Actual Study Completion Date: Aug 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Radiotherapy + surgery 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.	Procedure: adjuvant therapy; Procedure: diagnostic thoracoscopy; Procedure: therapeutic thoracoscopy; Procedure: video-assisted surgery; Radiation: radiation therapy

Outcome Measures

Primary Outcome Measures

1. Determine the feasibility of video-assisted thoracoscopic wedge resection (VAR) [Up to 10 years]

2. Determine the incidence of locoregional recurrence in patients treated with this regimen [Up to 10 years]

3. Determine the overall and disease-free survival [Up to 10 years]

4. Determine the short- and long-term complications associated with VAR in these patients [Up to 10 years]

5. Determine the technical feasibility of ipsilateral lymph node sampling and complete resection with VAR in these patients [Up to 10 years]

6. Determine the toxicity of adjuvant radiotherapy after VAR in these patients [Up to 10 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CCOP - Colorado Cancer Research Program, Incorporated	Denver	Colorado	United States	80224
2	John Stoddard Cancer Center at Iowa Methodist Medical Center	Des Moines	Iowa	United States	50309
3	Mercy Cancer Center at Mercy Medical Center-Des Moines	Des Moines	Iowa	United States	50314
4	Iowa Lutheran Hospital	Des Moines	Iowa	United States	50316-2301
5	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
6	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota	United States	55416
7	Midlands Cancer Center at Midlands Community Hospital	Papillion	Nebraska	United States	68128-4157
8	MBCCOP - University of New Mexico HSC	Albuquerque	New Mexico	United States	87131
9	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033-0850
10	Drexel University Hospital	Philadelphia	Pennsylvania	United States	19102-1192
11	Hillman Cancer Center at University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania	United States	15236
12	CCOP - MainLine Health	Wynnewood	Pennsylvania	United States	19096
13	CCOP - St. Vincent Hospital Cancer Center, Green Bay	Green Bay	Wisconsin	United States	54307-3453
14	Westmead Hospital	Westmead	New South Wales	Australia	2145
15	Instituto de Enfermedades Neoplasicas	Lima		Peru	34
16	San Juan City Hospital	San Juan		Puerto Rico	00936-7344

Sponsors and Collaborators

• Alliance for Clinical Trials in Oncology
• National Cancer Institute (NCI)

Investigators

• Study Chair: Hani Shennib, MD, Montreal General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alliance for Clinical Trials in Oncology
• ClinicalTrials.gov Identifier: NCT00002624
• Other Study ID Numbers: CALGB-9335; U10CA031946; CDR0000063987
• First Posted: Jan 27, 2003
• Last Update Posted: Jul 14, 2016
• Last Verified: Jul 1, 2016

• Keywords provided by Alliance for Clinical Trials in Oncology: stage I non-small cell lung cancer; squamous cell lung cancer; large cell lung cancer; adenocarcinoma of the lung; bronchoalveolar cell lung cancer
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Jul 14, 2016