Clinical trial NCT00087438: Stereotactic Body Radiation Therapy in Treating Patients With Inoperable Stage I or Stage II Non-Small Cell Lung Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: stage I non-small cell lung cancer
stage II non-small cell lung cancer
squamous cell lung cancer
large cell lung cancer
adenocarcinoma of the lung
bronchoalveolar cell lung cancer
Lead sponsor: Radiation Therapy Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-07-12
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: OBJECTIVES:

Primary

* Determine whether treatment with stereotactic body radiotherapy results in acceptable local control (i.e., ≥ 80%) in patients with medically inoperable stage I or II non-small cell lung cancer.

Secondary

* Determine treatment-related toxicity in patients treated with this therapy.
* Determine disease-free survival, overall survival, and patterns of failure in patients treated with this therapy.

OUTLINE: This is a multicenter study.

Patients receive 3 fractions of stereotactic body radiotherapy over 8-14 days in the absence of disease progression or unacceptable toxicity.

Patients are followed up at 6 and 12 weeks, every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study within 26 months.

Eligibility criteria: 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 therapy

Primary outcomes:
measure: Local Control at 2 Years
timeFrame: From the start of treatment to 2 years
Secondary outcomes:
measure: Proportion of Subjects With Specified Adverse Events
timeFrame: From randomization to last follow-up. Analysis occurred after all patients had been on study for at least 2 years. Maximum follow-up at time of analysis was 4.2 years.
measure: Rate of Local Recurrence at 2 Years
timeFrame: From the start of treatment to 2 years
measure: Rate of Regional Recurrence at 2 Years
timeFrame: From the start of treatment to 2 years
measure: Rate of Disseminated Recurrence at 2 Years
timeFrame: From the start of treatment to 2 years
measure: Rate of Disease-free Survival at 2 Years
timeFrame: From the start of treatment to 2 years
measure: Rate of Overall Survival at 2 Years
timeFrame: From the start of treatment to 2 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: James P. Wilmot Cancer Center at University of Rochester Medical Center
state: New York
city: Houston
country: United States
facility: M.D. Anderson Cancer Center at University of Texas
state: Texas
Study officials:
affiliation: Simmons Cancer Center
name: Robert D. Timmerman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hurkmans 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.
citation: Timmerman 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.
citation: Timmerman 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.
citation: Xiao 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.
citation: Timmerman 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.