Last reviewed · How we verify
Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
Phase 2 trial testing Arm 1 stereotactic body radiation therapy in Lung Cancer in 98 participants. Completed in 6 May 2020.
| Lead sponsor | Roswell Park Cancer Institute |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 98 |
| Start date | 12 September 2008 |
| Primary completion | 6 May 2020 |
| Estimated completion | 6 May 2020 |
| Sites | 3 locations across United States |
Roswell Park Cancer Institute
Adults 18 to 120, any sex, with Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| I High-dose Fraction SBRT | 24 | |
| 3 High-dose Fractions SBRT | 26 |
Median overall survival
| Group | Value | 95% CI |
|---|---|---|
| 1 High-dose Fraction SBRT | 39.0 | 27.2 – 51.9 |
| 3 High-dose Fractions SBRT | 38.3 | 21.1 – 49.0 |
Time frame: Baseline, weekly until 30 day follow-up.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | 1 High-dose Fraction SBRT | 3 High-dose Fractions SBRT |
|---|---|---|---|
| Gastroenteritis | Infections and infestations | — | — |
| Lung infection | Infections and infestations | — | — |
| Pneumonia | Infections and infestations | — | — |
| Syncope | Nervous system disorders | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | — | — |
| Reaction | System | 1 High-dose Fraction SBRT | 3 High-dose Fractions SBRT |
|---|---|---|---|
| Fatigue | General disorders | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Weight decreased | Investigations | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | — | — |
| Dysphagia | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Chest pain | General disorders | — | — |
| Pneumonia | Infections and infestations | — | — |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | — | — |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Pyrexia | General disorders | — | — |
| Bronchitis | Infections and infestations | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Contusion | Injury, poisoning and procedural complications | — | — |
| Fall | Injury, poisoning and procedural complications | — | — |
| Dizziness | Nervous system disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Wheezing | Respiratory, thoracic and mediastinal disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Hypotension | Vascular disorders | — | — |
| Deafness | Ear and labyrinth disorders | — | — |
| Vertigo | Ear and labyrinth disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Haematochezia | Gastrointestinal disorders | — | — |
| Hiatus hernia | Gastrointestinal disorders | — | — |
| Intestinal obstruction | Gastrointestinal disorders | — | — |
| Oesophageal stenosis | Gastrointestinal disorders | — | — |
| Rectal haemorrhage | Gastrointestinal disorders | — | — |
| Small intestinal obstruction | Gastrointestinal disorders | — | — |
| Asthenia | General disorders | — | — |
| Chest discomfort | General disorders | — | — |
| Chills | General disorders | — | — |
Most-reported serious reactions: Gastroenteritis, Lung infection, Pneumonia, Syncope, Acute kidney injury, Cough, Dyspnoea, Dyspnoea exertional.
Data from ClinicalTrials.gov NCT00843726 adverse events section.
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.
4 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00843726.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing