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A randomized multicentre control trial of stage III non-small cell lung cancer application of concomitant radiochemotherapy

A randomized multicentre control trial of stage III non-small cell lung cancer application of concomitant late course accelerated hyperfractionation radiochemotherapy with 3DCRT/PP vs 3DCRT/NP

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-09000487
Enrollment
Unknown
Registered
2009-08-01
Start date
2009-09-01
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

Group A:to receive concomitant radiochemotherapy with pemetrexed + cisplatin: pemetrexed 500mg/m2, i.v. drip d1
cisplatin 25mg/m2, i.v. drip d1-3. Radiotherapy carried out in the 1st and 4th week.
Group B:to receive concomitant radiochemotherapy with vinorelbine and cisplatin: Vinorelbine 25mg/m2, i.v. drip d1, 8

Sponsors

Shandong Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Locally advanced lung cancer (III a, III b) which can not be surgically resected; 2. Measurable lesions with clear pathological diagnosis; 3. Life expectancy>=6 months; 4. Age: 18-75 years, male or female;5. General state of health: ECOG 0-1 grade; 6. Pulmonary function: FEV1>70%; 7. Without any chemotherapy or radiotherapy; 8. Signed informed consent; 9. Subjects meet the following criteria for the clinical laboratory: HG>=100g/L, WBC>=3.5*10^9/L, neutrophilic leukocyte>=1.5*10^9, PLT100*10^9/L, CR<=1.5 *N, TB<=2.5*N, AST and ALT<=2.5*N, AKP<=2.5*N.

Exclusion criteria

Exclusion criteria: 1. Serious infection; 2. Uncontrollable diabetes: blood glucose> 200mg% any time; patients with blood glucose> 200mg% while fasting blood glucose <140mg% may join group; 3. Other serious diseases, such as myocardial infarction in 6 months; 4. Participated other clinical trials in 4 weeks or at present.

Design outcomes

Primary

MeasureTime frame
surviva;

Secondary

MeasureTime frame
effec;

Countries

China

Contacts

Public ContactBaosheng Li
baoshli@yahoo.com+86 0531 67626161

Outcome results

None listed

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