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A multicenter, randomized controlled Study, phase III trial of concurrent chemotherapy and different doses in thoracic 3-dimensional radiation therapy for stage IV non-small cell lung cancer

A multicenter, randomized controlled Study, phase III trial of concurrent chemotherapy and different doses in thoracic 3-dimensional radiation therapy for stage IV non-small cell lung cancer

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003749
Enrollment
Unknown
Registered
2013-10-23
Start date
2014-01-23
Completion date
Unknown
Last updated
2026-02-09

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

Conditions

Lung Cancer

Interventions

Intervention group:Chemotherapy+high-dose radiotherapy (DT GTV=70Gy)
Control group:Chemotherapy+low-dose radiotherapy (DT GTV=50Gy)

Sponsors

The Affiliated Hospital of Guiyang Medical University/Guizhou Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. NSCLC patients confirmed by pathology or cytology; 2. Clinical stage for stage IV (UICC staging 2009); 3. Cancer metastasis: the principles of radiotherapy metastases may intervene. [Metastasis of distant organs=70; 8. Subjects without major organ dysfunction, blood routine, lung, liver, kidney and heart function were normal; laboratory testing indicators must meet the following requirements: (1) Blood: WBC>=4.0×10^9/L, NE>=2.0×10^9/L, BPC>=100×10^9/L, Hemoglobin>=100g/L; (2) Liver function Normal; (3) Kidney functionNormal; (4) Lung function FEV1>50%, mild to moderate impairment of pulmonary function; 9. Patients have a good compliance as to treatment received and follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients do not conform to the pathologic type, cancer stage and PS of being in eligibility criteria; 2. Patients in advanced stages of cancer suffered from malignant pleural and pericardial effusion, or malignant pleural and pericardial effusion of patients with stage IV which have not controlled; 3. Diffuse liver, lung metastasis and has affected lung function of patients; 4. Patients with uncontrollable hypertension, diabetes, unstable angina pectoris, history of myocardial infarction, or attacked by symptomatic congestive heart failure, uncontrollable arrhythmia in past 12 months; Patients is bacterial, fungal or viral infection disease activity; Patients with mental disorders; Patients with severe impairment of lung function; 5. Pregnancy, lactation patients; 6. Patients were not only have non-small cell lung cancer but also other active malignancy before enter groups, but excluding non-melanoma skin cancer of basal cell, situ cervical cancer and cured in situ early prostate cancer; 7. Patients with allergies, known or may be allergic to drugs in research that can not be replaced; 8. Patients with poor adherence to treatment and follow-up; 9. Researchers believe that those who should not participate in this trial.

Design outcomes

Primary

MeasureTime frame
Overall survival;Local regional progression free survival;

Secondary

MeasureTime frame
Local response of the primary tumor;1-year local control rate of the primary tumor;Impact of subsequent therapy on survival (treatment for recurrence or re-metastasis after initial therapy);

Countries

China

Contacts

Public ContactLu Bing

Department of Oncology, the Affiliated Hospital of Guiyang Medical University/Guizhou Cancer Hospital

lbgymaaaa@sohu.com+86 13809432527

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 13, 2026