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Results of prospective, randomized, multicenter, double-blind phase III trial of DC intermittent chemotherapy or GC chemotherapy in treatment of advanced non-small cell lung cancer patients with COPD

Results of prospective, randomized, multicenter, double-blind phase III trial of DC intermittent chemotherapy or GC chemotherapy in treatment of advanced non-small cell lung cancer patients with COPD

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15006164
Enrollment
Unknown
Registered
2015-03-28
Start date
2015-05-01
Completion date
Unknown
Last updated
2017-04-18

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

The experimental group :docetaxel and paraplatin
The control group :gemcitabine and paraplatin

Sponsors

The First Affiliated Hospital Of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Non-small cell lung cancer (not including compound small cell carcinoma), newly confirmed by histology or cytology; 2. Never received surgery, chemotherapy, biological therapy, and radiation therapy in newly diagnosed non-small cell lung cancer; 3. The investigators estimate the stage IIIB-IV patients with lung cancer that they can not be surgical resection. The stage IIIB: T1-4N3M0, T4N0-3M0; The stage IV?: T1-4N0-3M1; 4. The disease can be assessed, according to the Response Evaluation Criteria in Solid Tumor (RECIST1.1), there is a lesion with measurable single path. And its longest diameter is measured >=10mm by spiral CT; 5. The patients with COPD are diagnosed clearly. In their pulmonary function tests,after the patients inhaled bronchodilators, FEV1 / FVC =90g/L(without blood transfusion in 14days);(2)BIL45ml/min(Cockcroft-Gault formula); 7. More than 65 years old; PS score 0-2 points; the estimated survival time is more than 3months, and the patients can complete above 2 cycles of chemotherapy.

Exclusion criteria

Exclusion criteria: 1. Non-small cell lung cancer and compound small cell carcinoma,newly confirmed by histology or cytology; 2. The newly diagnosed non-small cell lung cancer have ever received surgery, chemotherapy, biological therapy, and radiation therapy; 3. The stage IIIA patients with lung cancer are estimated that they can be with surgical resection by the investigators, or the patients in the stage IA, IB, IIA, IIB; 4. The disease can not be assessed, according to the Response Evaluation Criteria in Solid Tumor (RECIST1.1), there is a lesion with measurable single path.And its longest diameter is measured =90g/L(without blood transfusion in 14days);(2)BIL45ml/min (Cockcroft-Gault formula); 8. Less than 65 years old; PS score more than 2points; the estimated survival time is less than 3 months, and the patients can not complete above 2 cycles of chemotherapy; 9. The vital organs or the system of the patients exist serious primary disease; 10. The patients with mental or physical disabilities; 11. The patients with hepatitis A, hepatitis B, AIDS, tuberculosis and other infectious diseases or connective tissue disease in the active stage; 12. The patients with serious infections, especially lung infection; 13. The patients who participate in other clinical trials; 14. Any other situations not suitable for this study determined by the investigators.

Design outcomes

Primary

MeasureTime frame
Chest CT;

Secondary

MeasureTime frame
Blood-routine;Urine-routine;Stool-routine;Blood biochemical examination;Blood tumor marker;Pulmonary function test;Electrocardiogram;Abdomen B ultrasonography;Evaluation of Adverse Drug Reactions;Al - antitrypsin concentration;

Countries

China

Contacts

Public ContactYinYin Qin
qinyinyin8333@163.com+86 13610047638

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026