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Intensity modulated radiation therapy and branchtherapy for locally advanced peripheral non small cell lung cancer: multicenter randomized controlled trial

Intensity modulated radiation therapy and branchtherapy for locally advanced peripheral non small cell lung cancer: multicenter randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-17012591
Enrollment
Unknown
Registered
2017-09-05
Start date
2017-10-01
Completion date
Unknown
Last updated
2017-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-small cell lung cancer

Interventions

test group:branchtherapy
control group:IMRT

Sponsors

Affiliated Hospital of Southwest Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. pathology or cytology confirmed the initial treatment of peripheral non-small cell lung cancer, unresectable or with basic disease cannot tolerate the operation of A- stage B, surgical resection should be whether the multidisciplinary team decided to contain at least one department of thoracic surgery physicians to assess; 2. Aged 18~80 years old; 3. there is no contraindication for radiotherapy. Survival after radiotherapy is expected to be greater than 6 months; 4. ZPS score 0-2 points; 5. pulmonary function testing: forced expiratory volume in one second; FEV1 = 1.2 liters / sec or more than 50% expected value; 6. there was no history of other lung malignancies, nor systemic chemotherapy or chest radiotherapy for lung tumors; 7. women in child-bearing age were negative in urine and serum HCG 72 hours before treatment began; 8. normal bone marrow function, as follows: white blood cell count >4x10^9/L, >90g/L (hemoglobin transfusion case), neutrophil counts over 2*10^9/L, platelet count greater than 100 x 10^9/L, normal serum creatinine or creatinine clearance rate was higher than 60 ml/min, ALT, AST < 2.5 times the normal reference values. Bilirubin in normal range; 9. coagulation function is normal: PT 12 to 16S, INR 0.8 to 1.5, APTT24 to 36s, FIB2 to 4g/L, blood transfusion before examination: AIDS (HIV), syphilis (TP) are negative (-); 10. no lidocaine and other narcotic drugs allergy history; 11. the patients expressed informed consent and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. combined with serious history of cardiovascular diseases, such as hypertension, uncontrolled, unstable angina pectoris, congestive heart failure, acute myocardial infarction, and transmural myocardial infarction within 6 months; 2. patients with neuropathy (grade 2 or above) or psychotic; 3. in clinical stage T4 of phase IIIB clinical stage T4 (with extensive lung involvement such as mediastinum, heart, blood vessels, trachea, esophagus, vertebral, carina, and malignant pleural, pericardial effusion) in patients with exudative pleural effusion (even for cytology negative patients). Trace X-ray cannot detect pleural effusion can be excluded; 4. the lesions were located within 2cm of the airway bundle, and N3 patients developed supraclavicular or contralateral hilar lymph nodes; 5. there was a history of aggressive malignancies within three years (excluding non malignant melanoma of the skin, breast, cervical and oral carcinoma in situ); 6. chronic obstructive pulmonary disease increased within 30 days before admission, requiring hospitalization or patients who might not be able to tolerate this trial; 7. group of patients with acute bacterial or fungal infection, the need for intravenous anti infective treatment 8. liver dysfunction causes jaundice or coagulopathy; 9. pregnant or child-bearing women and men refuse to adopt appropriate contraceptive measures. 10. have a history of hypersensitivity to paclitaxel or cisplatin.

Design outcomes

Primary

MeasureTime frame
local control rate;

Secondary

MeasureTime frame
overall survival;progression-free survival;

Countries

China

Contacts

Public ContactSheng Lin

Affiliated Hospital of Southwest Medical University; Sichuan; Luzhou

lslinsheng@163.com+86 15108187773

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026