Stereotactic Body Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer

NCT00471835 | Withdrawn Phase 1

• 3 other identifiers: CCCWFU-62206CDR0000543743CCCWFU-IRB00000578
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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. PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic body radiation therapy and to see how well it works in treating patients with stage I or stage II non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

stage II non-small cell lung cancer; stage I non-small cell lung cancer; adenocarcinoma of the lung; adenosquamous cell lung cancer; large cell lung cancer; squamous cell lung cancer

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (Phase I)

• Time to progression and local control at 1 and 2 years (Phase II)

Secondary Outcomes (4)

• Rate of acute and late treatment-related toxicity related to specific symptoms, including gastrointestinal, cardiac, neurologic, hemorrhagic, and pulmonary symptoms

• Toxicity

• Patterns of failure and overall survival at 2 years

• Measurement of pre-treatment and post-treatment PET scan standardized uptake values and correlation of this data with local control at 1 and 2 years

Interventions

computed tomography PROCEDURE

positron emission tomography PROCEDURE

stereotactic body radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed stage I or II non-small cell lung cancer meeting the following criteria: * No bronchoalveolar cell carcinoma * Maximum T2 or T3 tumor size ≤ 5 cm * T3 primary tumor must be limited to chest wall * Primary tumor of any T stage must be within or touching the zone of the trachea or proximal bronchial tree, defined as a volume of 2 cm in all directions around the trachea and proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchi, right middle lobe bronchus, right and left lower lobe bronchi) * For lesions inferior to the proximal bronchial tree, the primary tumor must be within 2 cm of the esophagus * Patients with N1 (hilar) lymph nodes positive for malignancy based on size, fludeoxyglucose F 18 (FDG)-PET scan uptake, or biopsy are eligible if the N1 lymph nodes are located such that they are contiguously within the same stereotactic radiation treatment field as the primary tumor * Mediastinal lymph nodes must be ≤ 1 cm and no abnormal uptake on FDG-PET scan in those areas * Patients with \> 1 cm lymph nodes or abnormal FDG-PET scan (including suspicious but non-diagnostic uptake) are eligible if directed tissue biopsy of all abnormally identified areas are negative for cancer * No evidence of distant metastases * Suspected M1 disease based on pre-treatment PET imaging must be biopsied * If the biopsy is positive, the patient is ineligible * If the biopsy is negative and representative of the lesion in question, the patient is eligible * If the biopsy is non-diagnostic, consideration should be given to repeat biopsy * If the repeat biopsy remains non-diagnostic or a biopsy is not feasible, then the patient is ineligible * Technically resectable disease * Surgery refused or patient deemed medically inoperable due to co-morbid conditions PATIENT CHARACTERISTICS: * Zubrod performance status 0-2 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No synchronous primary or invasive malignancy within the past 2 years other than non-melanomatous skin cancer * No active systemic, pulmonary, or pericardial infection PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior chest radiotherapy (lung or mediastinum) * No other concurrent anticancer therapy, including other radiotherapy, radiofrequency ablation (or other antineoplastic interventional radiology techniques), chemotherapy, biological therapy, vaccine therapy, or surgery

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung

Interventions

Magnetic Resonance Spectroscopy; Radiosurgery

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Volker W. Stieber, MD

  Wake Forest University Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2007
• First Posted: May 10, 2007
• Study Start: January 1, 2007
• Last Updated: January 19, 2017

Record last verified: 2013-06