Clinical trial · Interventional
Stereotactic Body Radiation Therapy in Treating Patients With Inoperable Stage I or Stage II Non-Small Cell Lung Cancer
A Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Patients With Medically Inoperable Stage I/II Non-Small Cell Lung Cancer
NCT00087438CI-TRIAL-00036563completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Stereotactic body radiation therapy may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase II trial is studying how well stereotactic body radiation therapy works in treating patients with inoperable stage I or stage II non-small cell lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| stereotactic body radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Stereotactic body radiation therapy (SBRT)
- description
- 20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy
- interventionNames
- Radiation: stereotactic body radiation therapy
Primary outcomes (1)
- measure
- Local Control at 2 Years
- timeFrame
- From the start of treatment to 2 years
- description
- Local control is defined as absence of local failure, which is defined as the combination of primary tumor failure (PTF) or involved lobe failure (ILF). PTF was defined based on meeting two criteria: 1. Local enlargement defined as ≥ 20% increase in the longest diameter of the gross tumor volume (GTV) per computerized tomography (CT), and 2. Evidence of tumor viability. Tumor viability could be affirmed by either demonstrating positron emission tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, or by repeat biopsy confirming carcinoma. PTF included marginal failures occurring within 1 cm of the planning target volume (PTV). ILF is defined as failure beyond the primary tumor but within the involved lobe. Local control time is defined as time from start of treatment to the the date of local recurrence, last known follow-up (censored), or death without local failure (censored). Rates are estimated using the Kaplan-Meier method.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
* The following primary cancer subtypes are eligible:
* Squamous cell carcinoma
* Adenocarcinoma
* Large cell carcinoma
* Bronchoalveolar cell carcinoma
* Non-small cell carcinoma not otherwise specified
* Stage I or II disease based on 1 of the following tumor node metastasis (TNM) stage criteria:
* T1, N0, M0
* T2 (≤ 5 cm), N0, M0
* T3 (≤ 5 cm), N0, M0 (chest wall primary tumors only)
* No primary tumor of any T-stage within or touching the zone of the proximal bronchial tree\* NOTE: \*Defined as a volume 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, and right and left lower lobe bronchi)
* No primary T3 tumors involving the central chest (≤ 2 cm toward carina invasion) or structures of the mediastinum
* Any hilar or mediastinal lymph nodes \> 1 cm on CT scan OR demonstrating suspicious uptake on positron-emission tomography scan must be biopsied and confirmed negative for NSCLC
* The primary tumor must be deemed technically resectable with a reasonable possibility of obtaining a gross total resection with negative margins (defined as a potentially curative resection (PCR))
* Deemed medically inoperable based on pulmonary function for surgical resection of NSCLC secondary to an underlying physiological problem, including any of the following medical conditions\*:
* Baseline forced expiratory volume (FEV)\_1\< 40% of predicted
* Postoperative predicted FEV\_1 \< 30% of predicted
* Severely reduced diffusion capacity
* Baseline hypoxemia and/or hypercapnia
* Exercise oxygen consumption \< 50% of predicted
* Severe pulmonary hypertension
* Diabetes mellitus with severe end organ damage
* Severe cerebral, cardiac, or peripheral vascular disease
* Severe chronic heart disease NOTE: \*Patients who refuse a PCR due to preference, ideology, emotional or psychological issues, mental illness, or inability to give informed consent are not eligible
* No evidence of regional or distant metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Zubrod 0-2
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Cardiovascular
* See Disease Characteristics
* No active pericardial infection
Pulmonary
* See Disease Characteristics
* No active pulmonary infection
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active systemic infection
* No other concurrent illness that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent biologic therapy
* No concurrent vaccine therapy
Chemotherapy
* No concurrent chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No prior lung or mediastinal radiotherapy
* No concurrent standard fractionated radiotherapy
* No concurrent intensity modulated radiotherapy
* No concurrent cobalt-60 or charged particle beams (including electrons, protons, or heavier ions)
Surgery
* See Disease Characteristics
* No concurrent surgery
Other
* No other concurrent antineoplastic therapyReferences
Publications (5)
- BACKGROUNDHurkmans CW, Cuijpers JP, Lagerwaard FJ, Widder J, van der Heide UA, Schuring D, Senan S. Dosimetric evaluation of heterogeneity corrections for RTOG 0236: stereotactic body radiotherapy of inoperable Stage I-II non-small-cell lung cancer. In reply to Dr. Xiao et al. Int J Radiat Oncol Biol Phys. 2009 Sep 1;75(1):318; author reply 318. doi: 10.1016/j.ijrobp.2009.05.050. No abstract available. PMID 19695451
- BACKGROUNDTimmerman R, Galvin J, Michalski J, Straube W, Ibbott G, Martin E, Abdulrahman R, Swann S, Fowler J, Choy H. Accreditation and quality assurance for Radiation Therapy Oncology Group: Multicenter clinical trials using Stereotactic Body Radiation Therapy in lung cancer. Acta Oncol. 2006;45(7):779-86. doi: 10.1080/02841860600902213. PMID 16982540
- RESULTTimmerman R, Paulus R, Galvin J, Michalski J, Straube W, Bradley J, Fakiris A, Bezjak A, Videtic G, Johnstone D, Fowler J, Gore E, Choy H. Stereotactic body radiation therapy for inoperable early stage lung cancer. JAMA. 2010 Mar 17;303(11):1070-6. doi: 10.1001/jama.2010.261. PMID 20233825
- RESULTXiao Y, Papiez L, Paulus R, Timmerman R, Straube WL, Bosch WR, Michalski J, Galvin JM. Dosimetric evaluation of heterogeneity corrections for RTOG 0236: stereotactic body radiotherapy of inoperable stage I-II non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2009 Mar 15;73(4):1235-42. doi: 10.1016/j.ijrobp.2008.11.019. PMID 19251095
- RESULTTimmerman RD, Paulus R, Galvin J, et al.: Toxicity analysis of RTOG 0236 using stereotactic body radiation therapy to treat medically inoperable early stage lung cancer patients. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-151, S86, 2007.