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Postoperative Radiotherapy for Patients With IIIA (N2) Non-small Cell Lung Cancer

NCT00880971 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 394

Last updated 2020-10-05

No results posted yet for this study

Summary

Several important international randomized trials have shown that postoperative chemotherapy contributed to the improvement on 5 year survival rate by about 4% for patients with non-small cell lung cancer (NSCLC) after complete resection. But the overall survival rate was relatively low and the local recurrence was still the dominant failure pattern for stage IIIA (N2) disease even these patients received the postoperative chemotherapy. Several meta-analyses have shown that postoperative radiotherapy (PORT) has no effect on the survival improvement for patients with NSCLC after complete resection. However, sub-group analysis based on the same dataset of these meta-analyses showed that the PORT with conventional radiotherapy might be beneficial for stage IIIA (N2) disease. The 3D conform radiotherapy (3D-CRT) and intensity modified radiotherapy (IMRT) can increase the radiation dose to the target volume while decreasing the dose to risk organs comparing with the conventional radiotherapy. So it is expected that PORT using 3D-CRT or IMRT after postoperative chemotherapy will improve the local control and survival for stage IIIA (N2) NSCLC. Here, the investigators designed a phase III randomized trial to compare the 3-year disease free survival (DFS) and overall survival (OS) rates in patients with completely resected stage IIIA (N2) NSCLC who receive adjuvant chemotherapy alone or adjuvant chemotherapy plus PORT.

Conditions

Interventions

RADIATION

Postoperative 3D-CRT or IMRT

Postoperative radiotherapy using 3D-CRT or IMRT techniques, 2 Gy per fraction, total 25 fractions (50Gy) over 5 weeks.

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Luhua Wang, MD · Cancer Hosiptal, Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-18
Primary Completion
2019-12-31
Completion
2020-02-29

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00880971 on ClinicalTrials.gov