Non-small Cell Lung Cancer
Conditions
Keywords
Non-small Cell Lung Cancer, Split-course radiotherapy, consolidation immunotherapy
Brief summary
This Phase II study is to determine the efficacy of split-course thoracic radiotherapy plus concurrent chemotherapy with or without consolidation immunotherapy for patients with local advanced non-small cell lung cancer.
Detailed description
This Phase II study is to determine the efficacy of split-course thoracic radiotherapy plus concurrent chemotherapy with or without consolidation immunotherapy for local advanced non-small cell lung cancer patients. Patients were treated with hypo-RT (30Gy in 6 fractions) followed by hypo-boost (30Gy in 6 fractions) combined with concurrent weekly chemotherapy (docetaxel 25 mg/m2 and cisplatin 25 mg/m2). Consolidation immunotherapy were recommended for those without disease progression or persistent grade2+ toxicities following radiotherapy. The primary end point is progression-free survival, which is the time that passes from the first day of radiotherapy to the date at which disease progresses. Progression-free survival will be calculated using the Kaplan-Meier method.Toxicities will be graded according to CTCAE v. 5.0.
Interventions
RADIATIONsplit-course radiotherapy
The radiotherapy is delivered using simultaneous integrated boost (SIB)-intensity-modulated radiotherapy (IMRT). The dose of 30Gy with a fraction dose of 5Gy was delivered to PTV-GTV as the hypo-RT course. Patients were eligible to receive the hypo-boost when there was no disease progression and no persistent ≥G2 treatment-related toxicities. For patients with persistent ≥G2 toxicities, a re-evaluation was planned every 2 weeks to determine whether they were qualified to receive the hypoboost. All eligible patients underwent a repeat 4DCT simulation scan to reformulate the adaptive radiation therapy plan. The adaptive plan of the hypo-boost was delivered to the residual tumor (PTV-GTV-residual) at a dose of 30Gy in 6 fractions (5 Gy per fraction).
DRUGconcurrent chemotherapy
Patients received a weekly infusion of docetaxel (25 mg/m2) and cisplatin (25 mg/m2) concurrent with hypo-RT and hypo-boost therapy. Intended chemotherapy included 4 cycles throughout the course of treatment.
Patients without disease progression or persistent grade2+ toxicities after thoracic radiotherapy were recommended to receive consolidation immunotherapy
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed non-small cell lung cancer (NSCLC) by bronchoscopy, CT-guided biopsy, and endobronchial ultrasonography * Unresectable stage III disease based on the seventh edition of the TNM (tumor, node, metastases) staging system proposed by the American Joint Committee on Cancer * Measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; * Charlson Comorbidity Index score ≤4 * Previously treated with chemotherapy or treatment-naive * No previous chest radiotherapy, immunotherapy or biotherapy * Hemoglobin≥10 mg/dL, platelet≥100000/μL,absolute neutrophil count ≥1500/μL * Serum creatinine ≤1.25 times the upper normal limit(UNL), or creatinine clearance≥60 ml/min * Bilirubin ≤1.5 times UNL, AST（SGOT）≤2.5 times UNL ,ALT（SGPT）≤2.5 times UNL,alkaline phosphatase ≤5 times UNL * CB6 within normal limits * patients and their family signed the informed consents
Exclusion criteria
* Previous or recent another malignancy, except nonmelanoma skin cancer or cervical cancer in situ * Contraindication for chemotherapy * Malignant pleural or pericardial effusion. * Women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose * Women who has the probability of pregnancy without contraception * Tendency of hemorrhage * In other clinical trials within 30 days * Addicted in drugs or alcohol, AIDS patients * Uncontrollable seizure or psychotic patients without self-control ability * Severe allergy or idiosyncrasy * Not suitable for this study judged by researchers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | 2 year |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | 2 years |
| response rate | 2 months |
| rate of grade 3-4 radiation esophagitis | 1 year |
| rate of grade 3-4 radiation pneumonitis | 1 year |
Countries
China
Outcome results
None listed