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NCT Number: NCT00880971

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

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.

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Key information

Conditions

Thoracic Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-small Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cancer Hosiptal, Chinese Academy of Medical Sciences

Beijing, 100021, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Postoperative 3D-CRT or IMRT

Radiation

Postoperative radiotherapy using 3D-CRT or IMRT techniques, 2 Gy per fraction, total 25 fractions (50Gy) over 5 weeks.

Other names: Postoperative radiotherapy

Primary outcomes

  1. DFS

    Time frame: 3 years

    Disease free survival measures in months.

Secondary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2019
Study completion
2020
First posted
Apr 14, 2009
Registry last updated
Oct 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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