Lung CancerPhase 1NCT00009789
Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer And Lung Dysfunction
A Phase 1 study testing accelerated conformational radiotherapy in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology at 20 sites in United States.
Trial summary
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: Phase I trial to study the effectiveness of specialized high-dose radiation therapy in treating patients who have stage I non-small cell lung… 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?
- accelerated conformational radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 20 sitesUnited States
- Study dates
- Dec 2000to Jun 2010
- Phase
- Phase 1
- 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:
- Histologically or cytologically confirmed stage I (T1-2, N0) non-small cell lung cancer (NSCLC)
- Squamous cell carcinoma
- Basaloid carcinoma
- Adenocarcinoma
- Bronchoalveolar carcinoma
- Adenosquamous carcinoma
- Large cell carcinoma
- Large cell neuroendocrine carcinoma
- Giant cell carcinoma
- Sarcomatoid carcinoma
- Non-small cell carcinoma not otherwise specified
- Tridimensionally measurable solitary parenchymal lung lesion no greater than 4 cm in diameter by chest CT scan (lung windows)
- No metastatic disease or hilar or mediastinal lymphadenopathy
- Must have mediastinoscopy* (anterior, cervical, or both) if mediastinal lymph nodes are greater than 1.0 cm in diameter by chest CT scan
- No positive lymph nodes on mediastinoscopy* NOTE: *Patients may have positron-emission tomography in lieu of mediastinoscopy provided there is no fludeoxyglucose F 18 uptake in the mediastinum and hilum
- Poor surgical risk, as defined by 1 of the following:
- High risk due to nonpulmonary reasons, such as renal failure, cardiac failure, or hepatic dysfunction and deemed by thoracic surgeon to be unsuitable for lobectomy
- Pulmonary dysfunction indicated by one or more of the following:
- FEV_1 less than 40% of predicted
- DLCO less than 50% of predicted
- Oxygen dependent
- Chronic PaCO_2 greater than 45 mm Hg
- VO_2 less than 15 mL/kg/min
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- 0-2
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No weight loss of more than 10% within the past 6 months
- No other active (less than 30% risk of relapse after completion of prior therapy) malignancy except nonmelanoma skin cancer
Chemotherapy:
- No prior chemotherapy for NSCLC
Radiotherapy:
- No prior chest radiotherapy
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, 28203
Saint Luke's Hospital
Chesterfield, Missouri, 63017
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, 43210
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, 27534
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
Grand Island, Nebraska, 68803
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, 33021
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, 33458
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, 33140
Fairview University Medical Center - University Campus
Minneapolis, Minnesota, 55455
Great Plains Regional Medical Center
North Platte, Nebraska, 69103
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, 68198
Oswego Hospital
Oswego, New York, 13126
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224-1791
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13057
St. Joseph's Hospital Health Center - Syracuse
Syracuse, New York, 13203
SUNY Upstate Medical University Hospital
Syracuse, New York, 13210
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: Accelerated Conformal Radiotherapy for Stage I Non-Small Cell Lung Cancer in Patients With Pulmonary Dysfunction: A Phase I Study
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: Phase I trial to study the effectiveness of specialized high-dose radiation therapy in treating patients who have stage I non-small cell lung cancer and lung dysfunction.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated course of accelerated 3-dimensional conformal radiotherapy in patients with stage I non-small cell lung cancer with pulmonary dysfunction.
- Determine the short-term and long-term toxicity of this regimen in these patients.
- Determine local tumor control, failure-free survival, and overall survival in patients treated with this regimen.
- Determine the effect of radiotherapy dose volume relationships and pre-treatment pulmonary function studies on the incidence of pulmonary toxicity in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive accelerated 3-dimensional (3-D) conformal radiotherapy daily 5 days a week for 3.5-6 weeks.
Cohorts of 8 patients receive escalating fractions of accelerated 3-D conformal radiotherapy until the maximum tolerated course is determined. The maximum tolerated course is defined as the course at which no more than 2 patients develop at least grade 3 dose-limiting toxicity and no more than 1 patient develops at least grade 4 dose-limiting toxicity.
Patients are followed at 3 weeks, 6 weeks, 3 months, every 3 months for 2 years, and then every 6 months for 3 years.
- Conditions
- Lung Cancer
- Being tested
- accelerated conformational radiotherapy
- Keywords
- stage I non-small cell lung cancer, squamous cell lung cancer, large cell lung cancer, adenocarcinoma of the lung, adenosquamous cell lung cancer, 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.
accelerated conformational radiotherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy | Experimental | Patients receive accelerated 3-dimensional (3-D) conformal radiotherapy daily 5 days a week for 3.5-6 weeks.
Cohorts of 8 patients receive escalating fractions of accelerated 3-D conformal radiotherapy until the maximum tolerated course is determined. The maximum tolerated course is defined as the course at which no more than 2 patients develop at least grade 3 dose-limiting toxicity and no more than 1 patient develops at least grade 4 dose-limiting toxicity.
Patients are followed at 3 weeks, 6 weeks, 3 months, every 3 months for 2 years, and then every 6 months for 3 years. Receives: Radiation: accelerated conformational radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: Up to 5 years
Failure-free survival
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2003 (estimated)
- Study startDec 2000
- Primary completionJun 2007
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 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
- Jeffrey Bogart, MD, Study chair, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00009789
- Sponsor's protocol ID
- CALGB-39904
- Other IDs
- U10CA076001, CALGB-39904, CDR0000068409
- Status last verified
- Jul 2016
- First submitted
- 2 Feb 2001
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Bogart JA, Hodgson L, Seagren SL, Blackstock AW, Wang X, Lenox R, Turrisi AT 3rd, Reilly J, Gajra A, Vokes EE, Green MR. Phase I study of accelerated conformal radiotherapy for stage I non-small-cell lung cancer in patients with pulmonary dysfunction: CALGB 39904. J Clin Oncol. 2010 Jan 10;28(2):202-6. doi: 10.1200/JCO.2009.25.0753. Epub 2009 Nov 23.
PubMed 19933904
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
- Accelerated Conformal Radiotherapy for Stage I Non-Small Cell Lung Cancer in Patients With Pulmonary Dysfunction: A Phase I Study
- ClinicalTrials.gov ID
- NCT00009789
- Acronym / sponsor ID
- CALGB-39904
- Conditions
- Lung Cancer
- Keywords
- stage I non-small cell lung cancer, squamous cell lung cancer, large cell lung cancer, adenocarcinoma of the lung, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2000
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 5 Jun 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: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: Phase I trial to study the effectiveness of specialized high-dose radiation therapy in treating patients who have stage I non-small cell lung cancer and lung dysfunction.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated course of accelerated 3-dimensional conformal radiotherapy in patients with stage I non-small cell lung cancer with pulmonary dysfunction.
- Determine the short-term and long-term toxicity of this regimen in these patients.
- Determine local tumor control, failure-free survival, and overall survival in patients treated with this regimen.
- Determine the effect of radiotherapy dose volume relationships and pre-treatment pulmonary function studies on the incidence of pulmonary toxicity in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive accelerated 3-dimensional (3-D) conformal radiotherapy daily 5 days a week for 3.5-6 weeks.
Cohorts of 8 patients receive escalating fractions of accelerated 3-D conformal radiotherapy until the maximum tolerated course is determined. The maximum tolerated course is defined as the course at which no more than 2 patients develop at least grade 3 dose-limiting toxicity and no more than 1 patient develops at least grade 4 dose-limiting toxicity.
Patients are followed at 3 weeks, 6 weeks, 3 months, every 3 months for 2 years, and then every 6 months for 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy | Experimental | Radiation: accelerated conformational radiotherapyPatients receive accelerated 3-dimensional (3-D) conformal radiotherapy daily 5 days a week for 3.5-6 weeks. Cohorts of 8 patients receive escalating fractions of accelerated 3-D conformal radiotherapy until the maximum tolerated course is determined. The maximum tolerated course is defined as the course at which no more than 2 patients develop at least grade 3 dose-limiting toxicity and no more than 1 patient develops at least grade 4 dose-limiting toxicity. Patients are followed at 3 weeks, 6 weeks, 3 months, every 3 months for 2 years, and then every 6 months for 3 years. |
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 |
|---|---|---|
| accelerated conformational radiotherapy | Radiation | Radiotherapy |
Primary outcome
Overall survival
Time frame: Up to 5 years
Failure-free survival
Time frame: Up to 5 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 19933904Bogart JA, Hodgson L, Seagren SL, Blackstock AW, Wang X, Lenox R, Turrisi AT 3rd, Reilly J, Gajra A, Vokes EE, Green MR. Phase I study of accelerated conformal radiotherapy for stage I non-small-cell lung cancer in patients with pulmonary dysfunction: CALGB 39904. J Clin Oncol. 2010 Jan 10;28(2):202-6. doi: 10.1200/JCO.2009.25.0753. Epub 2009 Nov 23.
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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.
Jeffrey Bogart, MD study chair
State University of New York - Upstate Medical University
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing accelerated conformational radiotherapy in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology at 20 sites in United States.
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 20 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Overall survival (time frame: Up to 5 years). The study lists 2 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 NCT00009789, which also lists 1 linked publication.
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.