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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Completed

Phase 3

Conditions

Thoracic Neoplasms

Non-small Cell Lung Cancer

Treatments

Radiation: Postoperative 3D-CRT or IMRT

Study type

Interventional

Funder types

Other

Identifiers

NCT00880971

CH-L-015

Details and patient eligibility

About

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.

Full 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 compared with adjuvant chemotherapy alone in patients with completely resected stage IIIA (N2) NSCLC.

Secondary: To compare treatment-related toxic effects, 3-year OS, failure-free survival, and the patterns of failure.

OUTLINE: Eligible patients were randomized equally, using simple randomization, to either PORT or observation group.

Arm I: Patients undergo PORT using 3D-CRT or IMRT (50 Gy, 2 Gy once daily over 5 weeks) after adjuvant chemotherapy.

Arm II: Patients undergo adjuvant chemotherapy.

After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Enrollment

394 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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