Recurrent Lung Non-Small Cell Carcinoma Clinical Trial
Official title:
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 partially randomized phase I/II trial studies the side effects and best dose of image-guided, intensity-modulated photon or proton beam radiation therapy and to see how well they work in treating patients with stage II-IIIB non-small cell lung cancer. This trial is testing a new way of delivering radiation dose when only the tumor receives dose escalation while the surrounding normal structure is kept at standard level. Photon beam radiation therapy is a type of radiation therapy that uses x-rays or gamma rays that come from a special machine called a linear accelerator (linac). The radiation dose is delivered at the surface of the body and goes into the tumor and through the body. Proton beam radiation therapy is a type of radiation therapy that uses streams of protons (tiny particles with a positive charge) to kill tumor cells. Both methods are designed to give a higher than standard dose of treatment to the tumor and may reduce the amount of radiation damage to healthy tissue near a tumor.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | September 30, 2025 |
Est. primary completion date | September 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum tolerated dose (MTD) for intensity-modulated photon therapy (IMRT) (Phase I) | Will be defined as the highest simultaneous integrated boost volume (SIBV) dose that has posterior probability of dose-limiting toxicity (DLT) =< 30%. DLT are defined as Common Terminology Criteria for Adverse Events (CTCAE) 4.0 grade 3+ acute radiation toxicity, including esophagitis, pneumonitis, and skin reaction that are definitely, or probably related to radiation treatment. Toxicities will be tabulated by dose, severity, and relationship to radiation therapy. | 90 days | |
Primary | MTD for intensity-modulated proton therapy (IMPT) (Phase I) | Will be defined as the highest SIBV dose that has posterior probability of DLT =< 30%. DLT are defined as CTCAE 4.0 grade 3+ acute radiation toxicity, including esophagitis, pneumonitis, and skin reaction that are definitely, or probably related to radiation treatment. Toxicities will be tabulated by dose, severity, and relationship to radiation therapy. | 90 days | |
Primary | Survival free of grade >= 3 toxicity (with a target of at least 75%) (Phase II) | 6 months | ||
Primary | Local progression-free survival (75% at 6 months) d (Phase II) | Will be defined as tumor recurrence or progression inside or at the boundary of the volume defined by the 60 Gy (relative biological effectiveness) isodose line. A Bayesian method will be applied. | 6 months | |
Secondary | Time to local failure (Phase II) | The product-limit estimator of Kaplan and Meier will be used. | Up to 5 years | |
Secondary | Progression-free survival (Phase II) | The product-limit estimator of Kaplan and Meier will be used. | Up to 5 years | |
Secondary | Overall survival (Phase II) | The product-limit estimator of Kaplan and Meier will be used. | Up to 5 years | |
Secondary | Posterior probability that the DLT rate 90 days from day 1 of radiation therapy is more than 30% (Phase II) | A 90% credible interval will be reported for this rate. Toxicities will be tabulated by severity and relationship to radiation therapy. | 90 days | |
Secondary | Changes in selected biomarkers (Phase II) | Correlate changes in peripheral blood biomarkers (genes, ctDNA, microRNA, exosomes, proteins) and the study endpoints. Cox proportional hazards regression will be used to estimate the relationship between changes in selected biomarkers and time to local failure, progression-free survival, and overall survival. | Baseline to up to 5 years | |
Secondary | Change in symptom burden using European Quality of Life Five Dimension [EQ-5D]) (Phase II) Survey | Descriptive statistics and box plots will be used and will be measured by participants answers to the survey. | Up to 10 minutes | |
Secondary | Change in symptom burden using MD Anderson Symptom Inventory [MDASI]-Plus Survey | Descriptive statistics and box plots will be used and will be measured by participants answers to the survey. | Up to 10 minutes |
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