To Evaluate Postoperative 3D Conform Radiotherapy in Patients With IIIA (N2) Non-small Cell Lung Cancer
Conditions
Thoracic Neoplasms - Non-small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms - Thoracic Neoplasms
Conditions: Keywords
Lung, Carcinoma, radiotherapy, Surgery
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: 3D conform radiotherapy
Type: Radiation
Overall Status
Recruiting
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 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 has no effect on the survival improvement for patients with non-small lung cancer after complete resection. However, sub-group analysis based on the same dataset of these meta-analyses showed that the postoperative radiotherapy with conventional radiotherapy might be beneficial for stage IIIA (N2) disease. The 3D conform radiotherapy 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 postoperative 3D conform radiotherapy after postoperative chemotherapy will improve the local control and overall survival rate for stage IIIA (N2) non-small cell lung cancer. Here, the investigators designed a phase III randomized trial to compare the three years overall and disease free survival rate in patients with completely resected stage IIIA (N2) non-small cell lung cancer who receive the chemotherapy alone or the chemotherapy plus 3D conform radiotherapy.
Detailed Description
OBJECTIVES:

Primary: To determine whether administering chemotherapy (four cycles of NP regimen) plus 3D conform thoracic radiotherapy (50 Gy, 2 Gy once daily over 5 weeks) will improve 3-year survival compared with chemotherapy (four cycles of NP regimen) alone in patients with completely resected stage IIIA (N2) non-small cell lung cancer.

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

OUTLINE: This is a multicenter, randomized study. Patients are stratified according to histology (squamous cell vs other), number of mediastinum lymph nodes, and whether N2 disease has been diagnosed before operation.

Arm I: Patients undergo 3D conform thoracic radiotherapy (50 Gy, 2 Gy once daily over 5 weeks) after postoperative chemotherapy of four cycles of NP regimen.

Arm II: Patients undergo postoperative chemotherapy of four cycles of NP regimen.

After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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 and no extracapsular extension in a node

- Has undergone chemotherapy of four cycles of NP 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
Location
Cancer Insititute and Hosiptal of Chinese Academy of Medical Sciences
Beijing, China
Status: Recruiting
Contact: Guangfei Ou, PhD, MD - 8610-87788503 - guangfeiou@gmail.com
Start Date
January 2009
Completion Date
July 2012
Sponsors
Chinese Academy of Medical Sciences
Source
Chinese Academy of Medical Sciences
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page