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Multicenter trial of Combined irinotecan and Cisplatin versus combined Etoposide Cisplatin as the first line therapy for widespread phase small cell lung cancer

Multicenter trial of Combined irinotecan and Cisplatin versus combined Etoposide Cisplatin as the first line therapy for widespread phase small cell lung cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-08000229
Enrollment
Unknown
Registered
2008-12-08
Start date
2008-12-01
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

small cell lung cancer

Interventions

Group 1:IP scheme for four cycles.
Group 2:EP scheme for four cycles

Sponsors

Henan Province Tumour Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Patients with SCLC confirmed by cytology or histology; 2.be widespread stage of VALG; 3.never received any chemotherapy; 4. at least has a testable tumour by two ways diameters, and >=20mm scanned by general CT or MRI, or >=10mm by screw CT; 5. ECOG PS scores 0-2; 6.Aged 18-70; 7. be expected survival more than 3 months; 8.no dysfunction of main organ: WBC>=4.0*10^9/L, neutrophilic granulocyte>=2.0*10^9/L, platelet>=100*10^9/L, Hb>=95g/L; (1) Liver function: serum bilirubin less than the maximum normal value 1.5 folders; ALT and AST less than the maximum normal value 1.5 folders; (2) Renal function: creatinine clearance rate >=45mL/min; (3) Heart function: normal.

Exclusion criteria

Exclusion criteria: 1. with uncontrolled metastasis tumour in central nerve system; 2. with uncontrolled hypertension, unstable angina, MI history, or congestive heart-failure, uncontrolled arrhythmia, ischemic mucosa disease, ischemic heart condition, cardiac valve, peripheral neuropathy, infectious diseases, pregnancy or breed feeding woman, uncontrolled mental illness; 3. weight loss >=10% in last six weeks; 4. unable to stop the use of steroids drugs; 5. suffered other active tumours except non melanoma skin cancer, original cervical carcinoma and recovered early prostatic csarcinoma; 6. poor compliance; 7. others the trialist considered not suitable for attending the research.

Design outcomes

Primary

MeasureTime frame
Time of tumour progress (TTP);Survival rate;

Secondary

MeasureTime frame
tolerance and safety;Morbidity of other diseases;Quality of life;Efficient (ORR);Disease control rates (DCR);

Countries

China

Contacts

Public ContactZhiyong Ma
mazhiyong@csco.org.cn+86 0 13938239725

Outcome results

None listed

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