Clinical trial NCT04212052: Split-course Hypofractionated Radiotherapy With Concurrent Chemotherapy in Locally Advanced Non-small Cell Lung Cancer
Official title: Split-course Hypofractionated Radiotherapy With Concurrent Chemotherapy in Locally Advanced Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: Non-small Cell Lung Cancer
Split-course radiotherapy
consolidation immunotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival
timeFrame: 2 year
Secondary outcomes:
measure: Overall survival
timeFrame: 2 years
measure: response rate
timeFrame: 2 months
measure: rate of grade 3-4 radiation esophagitis
timeFrame: 1 year
measure: rate of grade 3-4 radiation pneumonitis
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University
Study officials:
affiliation: Sun Yat-sen University
name: Hui Liu, Ph.D
role: PRINCIPAL_INVESTIGATOR
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