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Postoperative sequential chemoradiotherapy compared with chemotherapy alone in patients with resected stage IIIA pN2 non-small-cell lung cancer: A multicenter phase III randomized trial.

Postoperative sequential chemoradiotherapy compared with chemotherapy alone in patients with resected stage IIIA pN2 non-small-cell lung cancer: A multicenter phase III randomized trial.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-08000067
Enrollment
Unknown
Registered
2008-03-17
Start date
2008-03-01
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

resected stage IIIA pN2 non-small-cell lung cancer

Interventions

Group B:sequential chemoradiotherapy
Group A:chemotherapy alone

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Histopathological confirmed NSCLC; Mediastinal lymph node postivie; Clinical stage IIIa; tumor completely resected; Radicalmediastinal lymphadenectomy was performed; Negative margin; Previously untreated; Adjuvant therapy start no greater than 8 weeks from surgery; Age 18–75 years; ECOG performance status 0-1; Normal cardiac and bone marrow (leucocyte >4.0*10^9/l, Platelet >100*10^9/l) functions and equate hepatic (bilirubin within normal limits, aspartate aminotransferase and alanine aminotranferase =1.5*upper limit of normal (ULN), alkaline phosphatase =2.5*ULN) and kidney (creatinine clearance >60 ml/min) functions; Forced expiratory volume >50%; Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital.

Exclusion criteria

Exclusion criteria: Carcinoid tumor, small cell lung carcinoma of lung; Tumor was not completely resected; Adjuvant therapy started greater than 8 weeks from surgical resection; Any other morbidity or situation with contraindication for chemotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment; Any previous or concurrent malignancy other than non-melanoma skin cancer or in situ cancer of uterine; Pregnant women; Drug allergy; Patients can not undertake follow-up visit, functions; Forced expiratory volume<50%.

Design outcomes

Primary

MeasureTime frame
progression-free survival;

Secondary

MeasureTime frame
Quality of life;local regional recurrence rate;local failure rate;overall survival;metastasis;

Countries

China

Contacts

Public ContactYou Lv
biothera@126.com+86 028 81812763

Outcome results

None listed

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