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

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ClinicalTrials.gov Identifier: NCT00880971
Recruitment Status : Completed
First Posted : April 14, 2009
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Luhua Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Description
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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 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.

Condition or disease Intervention/treatment Phase
Thoracic Neoplasms Non-small Cell Lung Cancer Radiation: Postoperative 3D-CRT or IMRT Phase 3

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 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 394 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post-Operative Radiation Therapy for Patients With pⅢA-N2 Non-Small Cell Lung Cancer After Complete Resection and Adjuvant Chemotherapy: A Prospective Randomized Phase Ⅲ Study
Actual Study Start Date : February 18, 2009
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : February 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: PORT
Patients undergo thoracic radiotherapy using 3D-CRT or IMRT (50 Gy, 2 Gy once daily over 5 weeks) after postoperative chemotherapy.
 Radiation: Postoperative 3D-CRT or IMRT
Postoperative radiotherapy using 3D-CRT or IMRT techniques, 2 Gy per fraction, total 25 fractions (50Gy) over 5 weeks.
Other Name: Postoperative radiotherapy
No Intervention: Non-PORT
Patients undergo postoperative chemotherapy.


Outcome Measures
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Primary Outcome Measures :
  1. DFS [ Time Frame: 3 years ]
    Disease free survival measures in months.


Secondary Outcome Measures :
  1. OS [ Time Frame: 3 years ]
    Overall survival measures in months.

  2. LRFS [ Time Frame: 3 years ]
    Loco-regional recurrence free survival measures in months.

  3. DMFS [ Time Frame: 3 years ]
    Distant metastasis free survival measures in months.

  4. Failure Patterns [ Time Frame: 3 years ]
    Loco-regional recurrence (LR) and Distant metastasis (DM)

  5. Toxicity of thoracic radiotherapy [ Time Frame: 6 months ]
    CTC AE 3.0 is used to evaluate the toxicities, including radiation esophagitis (RE) and pneumonitis (RP).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00880971


Locations
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China
Cancer Hosiptal, Chinese Academy of Medical Sciences
Beijing, China, 100021
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
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Principal Investigator: Luhua Wang, MD Cancer Hosiptal, Chinese Academy of Medical Sciences
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Luhua Wang, Chairman of Thoracic Group, Clinical Professor, Radiation Oncology Department, Cancer Hospital&Institute, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT00880971    
Other Study ID Numbers: CH-L-015
First Posted: April 14, 2009    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: October 2020
Keywords provided by Luhua Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences:
Lung
Carcinoma
radiotherapy
Surgery
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms