To Evaluate Postoperative 3D Conform Radiotherapy in Patients With IIIA (N2) Non-small Cell Lung Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Chinese Academy of Medical Sciences.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Luhua Wang, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00880971
First received: April 13, 2009
Last updated: December 15, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Thoracic Neoplasms
Non-small Cell Lung Cancer
Radiation: 3D conform radiotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Comparison of Postoperative 3D Conform Radiotherapy After Chemotherapy and Chemotherapy Alone in Patients With Completely Resected Stage IIIA(N2) Non-small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • Overall survival rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity of thoracic radiotherapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: January 2009
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Radiation: 3D conform radiotherapy
3D conform radiotherapy, 2 Gy per fraction, total 25 fractions (50Gy).
Other Name: Radiation
No Intervention: 2

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00880971

Contacts
Contact: Guangfei Ou, PhD, MD 8610-87788503 guangfeiou@gmail.com

Locations
China
Cancer Insititute and Hosiptal of Chinese Academy of Medical Sciences Recruiting
Beijing, China, 100021
Contact: Guangfei Ou, PhD, MD    8610-87788503    guangfeiou@gmail.com   
Principal Investigator: Luhua Wang, MD         
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
Principal Investigator: Luhua Wang, MD Cancer Instititute and Hosiptal of Chinese Academy of Medical Sciences
  More Information

Publications:

Responsible Party: Luhua Wang, Chairman of Thoracic Group, Clinical Professor, Radiation Oncology Department, Cancer Hospital&Institute, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT00880971     History of Changes
Other Study ID Numbers: CH-L-015
Study First Received: April 13, 2009
Last Updated: December 15, 2011
Health Authority: China: Ethics Committee

Keywords provided by Chinese Academy of Medical Sciences:
Lung
Carcinoma
radiotherapy
Surgery

Additional relevant MeSH terms:
Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Thoracic Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014