Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
Study Details
Study Description
Brief Summary
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known which regimen of radiation therapy is more effective in treating patients with non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying the side effects of two radiation therapy regimens and to see how well they work in treating patients with stage I or stage II non-small cell lung cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES:
Primary
- To compare the incidence of toxicity with two established stereotactic body radiotherapy (SBRT) regimens in patients with node-negative, peripheral stage I or II non-small cell lung cancer.
Secondary
-
To compare quality of life, patterns of failure, disease-free survival, and overall survival of these patients after treatment with one of two established SBRT regimens.
-
To correlate outcomes and toxicities with imaging and patient and tumor biomarkers.
OUTLINE: Patients are stratified according to Karnofsky performance status and treatment center. Patients are randomized to 1 of 2 treatment arms.
-
Arm I: Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).
-
Arm II: Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.
Quality of life is assessed periodically by the EORTC QLQ-C30 and -LC13 questionnaires
Blood and tissue samples may be collected periodically and examined for biomarkers via ELISA and immunoblotting.
After completion of study treatment, patients are followed for 5 years.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm I Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT). |
Radiation: Arm 1 stereotactic body radiation therapy
Patients undergo 1 high-dose fraction
|
| Experimental: Arm II Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT. |
Radiation: Arm II stereotactic body radiation therapy
Patients undergo 3 high-dose fractions
|
Outcome Measures
Primary Outcome Measures
- Incidence of AE Grade 3 or Higher Toxicity [1year]
Count of patients experiencing at least one grade 3 or higher adverse event. The Common Terminology Criteria for Adverse Events (CTCAE) v3.0 is used for assessing the adverse events. High grades AEs are considered worse.
- Overall Survival [5 years]
Median overall survival
- Correlation Between Blood and Serum Markers and Survival and Toxicity [4 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Histologically confirmed non-small cell lung cancer
-
T1-T2, N0 disease measuring ≤ 5 cm( T3 tumor based on chest wall involvement is Excluded)
-
Surgically resectable primary disease, however patient evaluated by thoracic oncologist and deemed medically inoperable OR patient refuses surgical resection
-
Age >= 18
Exclusion Criteria:
-
Prior thoracic radiation therapy
-
T2 or T3 tumor greater than 5 cm or T3 tumor based on chest wall involvement
-
Node positive or metastatic disease
-
Tumor location within the zone of the proximal bronchial tree. The proximal bronchial tree is defined as the carina, right and left main bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, and right and left lower lobe bronchi. The zone of the proximal bronchial tree is defined as a volume 2cm in all directions around the proximal bronchial tree.
-
No other conditions deemed by the PI or associates to make the patient ineligible for protocol investigations, procedures, and high-dose external beam radiotherapy (e.g., unable to lie still and breathe reproducibly)
-
Pregnant or unwilling to use adequate contraception
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263-0001 |
| 2 | SUNY Upstate Medical University | Syracuse | New York | United States | 13210 |
| 3 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
Sponsors and Collaborators
- Roswell Park Cancer Institute
Investigators
- Principal Investigator: Anurag K. Singh, MD, Roswell Park Cancer Institute
Study Documents (Full-Text)
More Information
Publications
None provided.- I 124407
- I 124407
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | 1 High-dose Fraction SBRT | 3 High-dose Fractions SBRT |
|---|---|---|
| Arm/Group Description | Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT). stereotactic body radiation therapy: Patients undergo 1 high-dose fraction | Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT. stereotactic body radiation therapy: Patients undergo 3 high-dose fractions |
| Period Title: Overall Study | ||
| STARTED | 49 | 49 |
| COMPLETED | 48 | 48 |
| NOT COMPLETED | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | 1 High-dose Fraction SBRT | 3 High-dose Fractions SBRT | Total |
|---|---|---|---|
| Arm/Group Description | Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT). stereotactic body radiation therapy: Patients undergo 1 high-dose fraction | Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT. stereotactic body radiation therapy: Patients undergo 3 high-dose fractions | Total of all reporting groups |
| Overall Participants | 49 | 49 | 98 |
| Age (Count of Participants) | |||
| <=18 years |
2
4.1%
|
2
4.1%
|
4
4.1%
|
| Between 18 and 65 years |
2
4.1%
|
7
14.3%
|
9
9.2%
|
| >=65 years |
45
91.8%
|
40
81.6%
|
85
86.7%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
76.5
(7.5)
|
74.5
(8.0)
|
75.5
(7.8)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
27
55.1%
|
23
46.9%
|
50
51%
|
| Male |
22
44.9%
|
26
53.1%
|
48
49%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
1
2%
|
0
0%
|
1
1%
|
| Asian |
1
2%
|
0
0%
|
1
1%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
3
6.1%
|
3
6.1%
|
6
6.1%
|
| White |
41
83.7%
|
43
87.8%
|
84
85.7%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
3
6.1%
|
3
6.1%
|
6
6.1%
|
Outcome Measures
| Title | Incidence of AE Grade 3 or Higher Toxicity |
|---|---|
| Description | Count of patients experiencing at least one grade 3 or higher adverse event. The Common Terminology Criteria for Adverse Events (CTCAE) v3.0 is used for assessing the adverse events. High grades AEs are considered worse. |
| Time Frame | 1year |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated and eligible patients |
| Arm/Group Title | I High-dose Fraction SBRT | 3 High-dose Fractions SBRT |
|---|---|---|
| Arm/Group Description | Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT). stereotactic body radiation therapy: Patients undergo 1 high-dose fraction | Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT. stereotactic body radiation therapy: Patients undergo 3 high-dose fractions |
| Measure Participants | 49 | 49 |
| Count of Participants [Participants] |
24
49%
|
26
53.1%
|
| Title | Overall Survival |
|---|---|
| Description | Median overall survival |
| Time Frame | 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated and eligible patients |
| Arm/Group Title | 1 High-dose Fraction SBRT | 3 High-dose Fractions SBRT |
|---|---|---|
| Arm/Group Description | Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT). stereotactic body radiation therapy: Patients undergo 1 high-dose fraction | Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT. stereotactic body radiation therapy: Patients undergo 3 high-dose fractions |
| Measure Participants | 49 | 49 |
| Median (95% Confidence Interval) [months] |
39.0
|
38.3
|
| Title | Correlation Between Blood and Serum Markers and Survival and Toxicity |
|---|---|
| Description | |
| Time Frame | 4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data was not collected for this outcome |
| Arm/Group Title | 1 High-dose Fraction SBRT | 3 High-dose Fractions SBRT |
|---|---|---|
| Arm/Group Description | Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT). stereotactic body radiation therapy: Patients undergo 1 high-dose fraction | Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT. stereotactic body radiation therapy: Patients undergo 3 high-dose fractions |
| Measure Participants | 0 | 0 |
Adverse Events
| Time Frame | Baseline, weekly until 30 day follow-up. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | 1 High-dose Fraction SBRT | 3 High-dose Fractions SBRT | ||
| Arm/Group Description | Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT). stereotactic body radiation therapy: Patients undergo 1 high-dose fraction | Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT. stereotactic body radiation therapy: Patients undergo 3 high-dose fractions | ||
All Cause Mortality |
||||
| 1 High-dose Fraction SBRT | 3 High-dose Fractions SBRT | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 33/49 (67.3%) | 29/49 (59.2%) | ||
Serious Adverse Events |
||||
| 1 High-dose Fraction SBRT | 3 High-dose Fractions SBRT | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/49 (4.1%) | 5/49 (10.2%) | ||
| Infections and infestations | ||||
| Gastroenteritis | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Lung infection | 0/49 (0%) | 0 | 1/49 (2%) | 2 |
| Pneumonia | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Nervous system disorders | ||||
| Syncope | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Renal and urinary disorders | ||||
| Acute kidney injury | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Dyspnoea | 1/49 (2%) | 1 | 1/49 (2%) | 1 |
| Dyspnoea exertional | 1/49 (2%) | 1 | 0/49 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| 1 High-dose Fraction SBRT | 3 High-dose Fractions SBRT | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 38/49 (77.6%) | 36/49 (73.5%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 2/49 (4.1%) | 2 | 0/49 (0%) | 0 |
| Ear and labyrinth disorders | ||||
| Deafness | 1/49 (2%) | 1 | 0/49 (0%) | 0 |
| Vertigo | 1/49 (2%) | 1 | 0/49 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Abdominal pain | 1/49 (2%) | 1 | 1/49 (2%) | 2 |
| Abdominal pain upper | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Constipation | 1/49 (2%) | 1 | 0/49 (0%) | 0 |
| Diarrhoea | 2/49 (4.1%) | 2 | 1/49 (2%) | 1 |
| Dysphagia | 2/49 (4.1%) | 2 | 3/49 (6.1%) | 3 |
| Haematochezia | 1/49 (2%) | 1 | 0/49 (0%) | 0 |
| Hiatus hernia | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Intestinal obstruction | 1/49 (2%) | 1 | 0/49 (0%) | 0 |
| Nausea | 3/49 (6.1%) | 3 | 4/49 (8.2%) | 4 |
| Oesophageal stenosis | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Rectal haemorrhage | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Small intestinal obstruction | 1/49 (2%) | 1 | 0/49 (0%) | 0 |
| Vomiting | 1/49 (2%) | 1 | 3/49 (6.1%) | 3 |
| General disorders | ||||
| Asthenia | 1/49 (2%) | 1 | 0/49 (0%) | 0 |
| Chest discomfort | 1/49 (2%) | 1 | 0/49 (0%) | 0 |
| Chest pain | 1/49 (2%) | 1 | 3/49 (6.1%) | 5 |
| Chills | 1/49 (2%) | 1 | 0/49 (0%) | 0 |
| Disease progression | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Fatigue | 18/49 (36.7%) | 21 | 21/49 (42.9%) | 22 |
| Oedema peripheral | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Pain | 1/49 (2%) | 1 | 1/49 (2%) | 1 |
| Pyrexia | 1/49 (2%) | 2 | 2/49 (4.1%) | 2 |
| Infections and infestations | ||||
| Bronchitis | 0/49 (0%) | 0 | 2/49 (4.1%) | 2 |
| Cellulitis | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Oral candidiasis | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Orchitis | 1/49 (2%) | 1 | 0/49 (0%) | 0 |
| Pneumonia | 3/49 (6.1%) | 4 | 3/49 (6.1%) | 3 |
| Respiratory tract infection | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Rhinitis | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Sinusitis | 1/49 (2%) | 1 | 1/49 (2%) | 1 |
| Upper respiratory tract infection | 0/49 (0%) | 0 | 2/49 (4.1%) | 2 |
| Urinary tract infection | 2/49 (4.1%) | 2 | 0/49 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Contusion | 2/49 (4.1%) | 2 | 0/49 (0%) | 0 |
| Fall | 1/49 (2%) | 1 | 2/49 (4.1%) | 2 |
| Hip fracture | 1/49 (2%) | 1 | 1/49 (2%) | 2 |
| Radiation pneumonitis | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Rib fracture | 1/49 (2%) | 1 | 0/49 (0%) | 0 |
| Spinal compression fracture | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Wrist fracture | 1/49 (2%) | 1 | 0/49 (0%) | 0 |
| Investigations | ||||
| Weight decreased | 3/49 (6.1%) | 3 | 4/49 (8.2%) | 4 |
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 3/49 (6.1%) | 4 | 4/49 (8.2%) | 4 |
| Dehydration | 1/49 (2%) | 1 | 0/49 (0%) | 0 |
| Diabetes mellitus | 1/49 (2%) | 1 | 0/49 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Musculoskeletal chest pain | 4/49 (8.2%) | 5 | 2/49 (4.1%) | 2 |
| Musculoskeletal discomfort | 0/49 (0%) | 0 | 1/49 (2%) | 2 |
| Musculoskeletal pain | 0/49 (0%) | 0 | 3/49 (6.1%) | 3 |
| Musculoskeletal stiffness | 1/49 (2%) | 1 | 0/49 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Benign salivary gland neoplasm | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Nervous system disorders | ||||
| Dementia | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Dizziness | 2/49 (4.1%) | 2 | 0/49 (0%) | 0 |
| Encephalopathy | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Hypoaesthesia | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Muscle contractions involuntary | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Paraesthesia | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Tremor | 1/49 (2%) | 1 | 0/49 (0%) | 0 |
| Psychiatric disorders | ||||
| Anxiety | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Confusional state | 1/49 (2%) | 1 | 0/49 (0%) | 0 |
| Depression | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Hallucination | 1/49 (2%) | 1 | 0/49 (0%) | 0 |
| Insomnia | 0/49 (0%) | 0 | 2/49 (4.1%) | 2 |
| Renal and urinary disorders | ||||
| Acute kidney injury | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Micturition urgency | 1/49 (2%) | 1 | 0/49 (0%) | 0 |
| Pollakiuria | 1/49 (2%) | 1 | 0/49 (0%) | 0 |
| Renal pain | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Reproductive system and breast disorders | ||||
| Breast pain | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Chronic obstructive pulmonary disease | 1/49 (2%) | 1 | 1/49 (2%) | 1 |
| Cough | 8/49 (16.3%) | 8 | 4/49 (8.2%) | 4 |
| Dysphonia | 1/49 (2%) | 1 | 1/49 (2%) | 1 |
| Dyspnoea | 13/49 (26.5%) | 16 | 11/49 (22.4%) | 12 |
| Dyspnoea exertional | 1/49 (2%) | 1 | 0/49 (0%) | 0 |
| Haemoptysis | 1/49 (2%) | 1 | 1/49 (2%) | 1 |
| Hypoxia | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Painful respiration | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Pleural effusion | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Pneumonitis | 1/49 (2%) | 1 | 0/49 (0%) | 0 |
| Productive cough | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Respiratory tract congestion | 1/49 (2%) | 1 | 0/49 (0%) | 0 |
| Sinus congestion | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Upper-airway cough syndrome | 0/49 (0%) | 0 | 3/49 (6.1%) | 3 |
| Wheezing | 2/49 (4.1%) | 2 | 0/49 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Decubitus ulcer | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Nail disorder | 1/49 (2%) | 1 | 0/49 (0%) | 0 |
| Pain of skin | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Pruritus | 1/49 (2%) | 1 | 1/49 (2%) | 1 |
| Rash | 1/49 (2%) | 1 | 2/49 (4.1%) | 2 |
| Skin discolouration | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Skin disorder | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Skin ulcer | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Telangiectasia | 1/49 (2%) | 1 | 0/49 (0%) | 0 |
| Vascular disorders | ||||
| Haematoma | 1/49 (2%) | 1 | 0/49 (0%) | 0 |
| Hypertension | 0/49 (0%) | 0 | 1/49 (2%) | 1 |
| Hypotension | 2/49 (4.1%) | 2 | 0/49 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Senior Administrator, Compliance - Clinical Research Services |
|---|---|
| Organization | Roswell Park Cancer Institute |
| Phone | 7168451300 |
| adrienne.groman@roswellpark.org |
- I 124407
- I 124407