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

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:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

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

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:

[No authors listed] Chemotherapy in non-small cell lung cancer: a meta-analysis using updated data on individual patients from 52 randomised clinical trials. Non-small Cell Lung Cancer Collaborative Group. BMJ. 1995 Oct 7;311(7010):899-909.

[No authors listed] Postoperative radiotherapy in non-small-cell lung cancer: systematic review and meta-analysis of individual patient data from nine randomised controlled trials. PORT Meta-analysis Trialists Group. Lancet. 1998 Jul 25;352(9124):257-63.

Keller SM, Adak S, Wagner H, Herskovic A, Komaki R, Brooks BJ, Perry MC, Livingston RB, Johnson DH. A randomized trial of postoperative adjuvant therapy in patients with completely resected stage II or IIIA non-small-cell lung cancer. Eastern Cooperative Oncology Group. N Engl J Med. 2000 Oct 26;343(17):1217-22.

Lally BE, Zelterman D, Colasanto JM, Haffty BG, Detterbeck FC, Wilson LD. Postoperative radiotherapy for stage II or III non-small-cell lung cancer using the surveillance, epidemiology, and end results database. J Clin Oncol. 2006 Jul 1;24(19):2998-3006. Epub 2006 Jun 12.

Machtay M, Lee JH, Shrager JB, Kaiser LR, Glatstein E. Risk of death from intercurrent disease is not excessively increased by modern postoperative radiotherapy for high-risk resected non-small-cell lung carcinoma. J Clin Oncol. 2001 Oct 1;19(19):3912-7.

Matsuguma H, Nakahara R, Ishikawa Y, Suzuki H, Inoue K, Katano S, Yokoi K. Postoperative radiotherapy for patients with completely resected pathological stage IIIA-N2 non-small cell lung cancer: focusing on an effect of the number of mediastinal lymph node stations involved. Interact Cardiovasc Thorac Surg. 2008 Aug;7(4):573-7. Epub 2008 Apr 15.

Douillard JY, Rosell R, De Lena M, Riggi M, Hurteloup P, Mahe MA; Adjuvant Navelbine International Trialist Association. Impact of postoperative radiation therapy on survival in patients with complete resection and stage I, II, or IIIA non-small-cell lung cancer treated with adjuvant chemotherapy: the adjuvant Navelbine International Trialist Association (ANITA) Randomized Trial. Int J Radiat Oncol Biol Phys. 2008 Nov 1;72(3):695-701. Epub 2008 Apr 24.

Strauss GM, Herndon JE 2nd, Maddaus MA, Johnstone DW, Johnson EA, Harpole DH, Gillenwater HH, Watson DM, Sugarbaker DJ, Schilsky RL, Vokes EE, Green MR. Adjuvant Paclitaxel Plus Carboplatin Compared With Observation in Stage IB Non-Small-Cell Lung Cancer: CALGB 9633 With the Cancer and Leukemia Group B, Radiation Therapy Oncology Group, and North Central Cancer Treatment Group Study Groups. J Clin Oncol. 2008 Sep 22; [Epub ahead of print]

Ng R, Hasan B, Mittmann N, Florescu M, Shepherd FA, Ding K, Butts CA, Cormier Y, Darling G, Goss GD, Inculet R, Seymour L, Winton TL, Evans WK, Leighl NB; Working Group on Economic Analysis; Lung Disease Site Group; National Cancer Institute of Canada Clinical Trials Group. Economic analysis of NCIC CTG JBR.10: a randomized trial of adjuvant vinorelbine plus cisplatin compared with observation in early stage non-small-cell lung cancer--a report of the Working Group on Economic Analysis, and the Lung Disease Site Group, National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2007 Jun 1;25(16):2256-61.

Dunant A, Pignon JP, Le Chevalier T. Adjuvant chemotherapy for non-small cell lung cancer: contribution of the International Adjuvant Lung Trial. Clin Cancer Res. 2005 Jul 1;11(13 Pt 2):5017s-5021s.

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 June 18, 2013