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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


Phase 3
18 Years
70 Years
Open (Enrolling)
Both
Thoracic Neoplasms, Non-small Cell Lung Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival rate

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Luhua Wang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Instititute and Hosiptal of Chinese Academy of Medical Sciences

Authority:

China: Ethics Committee

Study ID:

CH-L-015

NCT ID:

NCT00880971

Start Date:

January 2009

Completion Date:

July 2012

Related Keywords:

  • Thoracic Neoplasms
  • Non-Small Cell Lung Cancer
  • Lung
  • Carcinoma
  • radiotherapy
  • Surgery
  • Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Thoracic Neoplasms

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