Status:
COMPLETED
Postoperative Radiotherapy for Patients With IIIA (N2) Non-small Cell Lung Cancer
Lead Sponsor:
Chinese Academy of Medical Sciences
Conditions:
Thoracic Neoplasms
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 ca...
Detailed Description
OBJECTIVES: Primary: To determine whether administering adjuvant chemotherapy (four cycles of platinum-based doublet regimen) plus PORT (50 Gy, 2 Gy once daily over 5 weeks) will improve 3-year DFS c...
Eligibility Criteria
Inclusion
- Completely resected disease by lobectomy, bilobectomy. Complete dissection of lymph nodes at levels 4, 7, and 10 in case of right-sided thoracotomy and at levels 4 (if accessible), 5, 6, 7, and 10 in case of left-sided thoracotomy.
- Histologically N2 disease after surgery. Negative margins
- Has undergone chemotherapy of four cycles of platinum-based doublet regimen and no recurrence and metastasis
Exclusion
- Pregnant or nursing
- ECOG performance status \> 1
- Post-operative FEV\_1 \< 1 L (or \< 35% theoretical value, PO\_2 \< 70 mm Hg, and PCO\_2 \> 45 mm Hg)
- Severe cardiac disease within the past 6 months, including the following: Arrhythmia, Congestive heart failure, Infarction, Pacemaker
- Severe pulmonary disease within the past 6 months
- Other prior or concurrent neoplasm, except for basal cell carcinoma of the skin or carcinoma in situ of the cervix
- Severe or uncontrolled systemic disease
- Familial, social, geographic, or psychological conditions that would preclude study participation
Key Trial Info
Start Date :
February 18 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 29 2020
Estimated Enrollment :
394 Patients enrolled
Trial Details
Trial ID
NCT00880971
Start Date
February 18 2009
End Date
February 29 2020
Last Update
October 5 2020
Active Locations (1)
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1
Cancer Hosiptal, Chinese Academy of Medical Sciences
Beijing, China, 100021