Lung CancerPhase 2NCT00002624
Video-Assisted Surgery Followed by Radiation Therapy in Treating Patients With Stage I Non-small Cell Lung Cancer and Poor Heart and Lung Function
A Phase 2 study testing adjuvant therapy, diagnostic thoracoscopy and therapeutic thoracoscopy in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology at 16 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- adjuvant therapy, diagnostic thoracoscopy and therapeutic thoracoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 16 sitesin 4 countries
- Study dates
- Dec 1994to Aug 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
16 sites in 4 countries.
16 sites in 4 countries
United States13 sites
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, 80224
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Mercy Cancer Center at Mercy Medical Center-Des Moines
Des Moines, Iowa, 50314
Iowa Lutheran Hospital
Des Moines, Iowa, 50316-2301
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54307-3453
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
Midlands Cancer Center at Midlands Community Hospital
Papillion, Nebraska, 68128-4157
Drexel University Hospital
Philadelphia, Pennsylvania, 19102-1192
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15236
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096
About this study
Official title: VIDEO ASSISTED WEDGE RESECTION (VAR) AND RADIOTHERAPY FOR HIGH RISK T1 NON-SMALL CELL LUNG CANCER: A PHASE II STUDY
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- adjuvant therapy, diagnostic thoracoscopy, therapeutic thoracoscopy, video-assisted surgery, radiation therapy
- Keywords
- stage I non-small cell lung cancer, squamous cell lung cancer, large cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung, Adenocarcinoma, Bronchiolo-Alveolar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adjuvant therapyProcedure or surgery
diagnostic thoracoscopyProcedure or surgery
therapeutic thoracoscopyProcedure or surgery
video-assisted surgeryProcedure or surgery
radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy + surgery | Experimental | 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. Receives: Procedure: adjuvant therapy; Procedure: diagnostic thoracoscopy; Procedure: therapeutic thoracoscopy; Procedure: video-assisted surgery; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the feasibility of video-assisted thoracoscopic wedge resection (VAR)
Measured: Up to 10 years
Determine the incidence of locoregional recurrence in patients treated with this regimen
Measured: Up to 10 years
Determine the overall and disease-free survival
Measured: Up to 10 years
Determine the short- and long-term complications associated with VAR in these patients
Measured: Up to 10 years
Determine the technical feasibility of ipsilateral lymph node sampling and complete resection with VAR in these patients
Measured: Up to 10 years
Determine the toxicity of adjuvant radiotherapy after VAR in these patients
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startDec 1994
- Primary completionApr 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Hani Shennib, MD, Study chair, Montreal General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002624
- Sponsor's protocol ID
- CALGB-9335
- Other IDs
- U10CA031946, CDR0000063987
- Status last verified
- Jul 2016
- First submitted
- 1 Nov 1999
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Shennib 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.
PubMed 15821648Bogart 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIDEO ASSISTED WEDGE RESECTION (VAR) AND RADIOTHERAPY FOR HIGH RISK T1 NON-SMALL CELL LUNG CANCER: A PHASE II STUDY
- ClinicalTrials.gov ID
- NCT00002624
- Acronym / sponsor ID
- CALGB-9335
- Conditions
- Lung Cancer
- Keywords
- stage I non-small cell lung cancer, squamous cell lung cancer, large cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 1994
- Primary completion
- Apr 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy + surgery | Experimental | Procedure: adjuvant therapy, Procedure: diagnostic thoracoscopy, Procedure: therapeutic thoracoscopy, Procedure: video-assisted surgery, Radiation: radiation therapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adjuvant therapy | Procedure or surgery | Radiotherapy + surgery |
| diagnostic thoracoscopy | Procedure or surgery | Radiotherapy + surgery |
| therapeutic thoracoscopy | Procedure or surgery | Radiotherapy + surgery |
| video-assisted surgery | Procedure or surgery | Radiotherapy + surgery |
| radiation therapy | Radiation | Radiotherapy + surgery |
Primary outcome
Determine the feasibility of video-assisted thoracoscopic wedge resection (VAR)
Time frame: Up to 10 years
Determine the incidence of locoregional recurrence in patients treated with this regimen
Time frame: Up to 10 years
Determine the overall and disease-free survival
Time frame: Up to 10 years
Determine the short- and long-term complications associated with VAR in these patients
Time frame: Up to 10 years
Determine the technical feasibility of ipsilateral lymph node sampling and complete resection with VAR in these patients
Time frame: Up to 10 years
Determine the toxicity of adjuvant radiotherapy after VAR in these patients
Time frame: Up to 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2016.
- Results publication: PubMed 15821648Shennib 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.
- Results publicationBogart 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hani Shennib, MD study chair
Montreal General Hospital
16 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing adjuvant therapy, diagnostic thoracoscopy and therapeutic thoracoscopy in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology at 16 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Australia, Peru, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the feasibility of video-assisted thoracoscopic wedge resection (VAR) (time frame: Up to 10 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002624, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2016.