Using advanced radiation therapy techniques to treat stage II-IIIB non-small cell lung cancer
Phase I/II Trial of Image-Guided, Intensity-Modulated Photon (IMRT) or Scanning Beam Proton Therapy (IMPT) Both With Simultaneous Integrated Boost (SIB) Dose Escalation to the Gross Tumor Volume (GTV) With Concurrent Chemotherapy for Stage II/III Non-Small Cell Lung Cancer (NSCLC)
This study is testing new radiation therapy techniques to see if they can safely treat people with stage II-IIIB non-small cell lung cancer while causing less harm to healthy tissue.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT01629498 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness and safety of image-guided, intensity-modulated photon and proton beam radiation therapy in patients with stage II-IIIB non-small cell lung cancer. The study aims to determine the maximum tolerated dose of these therapies while minimizing damage to surrounding healthy tissue. It includes a comparison of treatment-related toxicity and local progression-free survival between the two radiation methods. Additionally, the trial will assess various biomarkers and symptom burden throughout the treatment process.
Who should consider this trial
Good fit: Ideal candidates include individuals with unresected stage II-IIIB non-small cell lung cancer who are suitable for concurrent chemoradiation therapy.
Not a fit: Patients with early-stage lung cancer or those who have already undergone extensive treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes and reduced side effects for patients with advanced non-small cell lung cancer.
How similar studies have performed: Other studies have shown promising results with similar radiation therapy approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathologically proven diagnosis of unresected stage II-IIIB, or recurrent after surgical resection or stereotactic body radiation therapy (SBRT) non-small cell lung cancer * Suitability for concurrent chemoradiation therapy per treating physician's assessment * Karnofsky performance status (KPS) score \>= 70 * Weight loss \< 15% in the 3 months before diagnosis * Prior receipt of induction chemotherapy followed by referral for concurrent chemoradiation is allowed * Adequate lung function indicated by forced expiratory volume at 1 second (FEV1) \>= 1 L is required * The primary tumor and/or regional lymph nodes must be evaluable radiographically * The gross target volume (GTV) is suitable for motion management using 4 dimensional computed tomography (4D CT), internal target volume (ITV), or respiratory gating; in addition, the target coverage and normal tissue constraints must be met as specified in protocol accounting for the respiratory motion of anatomy as a whole (not just the tumor) * No prior radiation to the mediastinal structures * Hemoglobin \>= 9.0 g/dL * Absolute neutrophil count (ANC) \>= 1,500/mm\^3 * Platelet count \>= 100,000/mm\^3 * Total bilirubin =\< 1.5 times the upper limit of normal (ULN) * Alanine and aspartate transaminases (ALT and AST) =\< 2.5 times the ULN (=\< 5 x ULN for patients with liver involvement) * Creatinine =\< 1.5 times ULN * Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of MD Anderson Cancer Center (MDACC) Exclusion Criteria: * Prior radiotherapy to any anatomic regions that would result in overlap of radiation dose distribution to critical structures (esophagus, heart, spinal cord, brachial plexus) * T4 tumor with direct invasion of esophagus, spinal cord, major blood vessel, or heart * Pregnancy * Patients of childbearing potential must practice appropriate contraception * Patient refusal
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Zhongxing Liao — M.D. Anderson Cancer Center
- Study coordinator: Zhongxing Liao
- Email: zliao@mdanderson.org
- Phone: 713-563-2300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.