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A Randomized Phase II Study Preoperative Chemotherapy Versus Preoperative Concurrent Chemoradiotherapy for Patients With Biopsy-Proven N2 Stage IIIA Non-Small Cell Lung Cancer

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

A Randomized Phase II Study Preoperative Chemotherapy Versus Preoperative Concurrent Chemoradiotherapy for Patients With Biopsy-Proven N2 Stage IIIA Non-Small Cell Lung Cancer

Preoperative Therapy Arm 1. (preoperative chemotherapy) Paclitaxel (90 mg/m2)on day 1 and 8
Cisplatin (40 mg/m2)on day 1 and 8. q 3 weeks, 2 cycles

Arm 2. (preoperative chemoradiotherapy) Paclitaxel (50 mg/m2)on day 1, 8, 15, 22 & 29
Cisplatin (20 mg/m2)on day 1, 8, 15, 22 & 29. Thoracic radiation therapy (TRT) 1.8 Gy
daily, five times per week (45 Gy target dose in 5 weeks).

Postoperative Consolidation Chemotherapy:

Paclitaxel (90 mg/m2) on day 1 and 8. Cisplatin (40 mg/m2) on day 1 and 8. q 3weeks, 2

Inclusion Criteria:

1. Histologic or cytologic diagnosis of non-small cell lung cancer.

2. Presence of biopsy-proven N2 stage IIIA, according to the American Joint Committee on
Cancer (AJCC), with none of the mediastinal lymph nodes > 3 cm in largest diameter.

3. Tumor amenable to surgical resection.

4. At least one unidimensional measurable lesion meeting Response Evaluation Criteria in
Solid Tumors (RECIST. 2000).

5. No prior tumor therapy (surgery, radiotherapy, chemotherapy, immunotherapy, or any
other type of tumor therapy).

6. Performance status of 0-1 on ECOG scale.

7. At least 18 years old.

8. Patient compliance that allows adequate follow-up.

9. Medical fitness of patients adequate for radical NSCLC surgery.

10. Adequate organ function including the following:Adequate hematologic function: WBC
count ≥ 4,000/uL, absolute neutrophil count (ANC) ≥ 1,500/uL, platelet count ≥
100,000/uL, and hemoglobin ≥ 10 gm/dL.Adequate hepatic function: bilirubin ≤ 1.5 x
UNL, ALT or AST ≤ 2.5 x UNL.Adequate renal function: creatinine ≤ 1.5mg/dL.

11. Signed informed consent from patient or legal representative.12. Patients with
reproductive potential must use an approved contraceptive method during and for 3
months after the study. Females with childbearing potential must have a negative
urine hCG test within 7 days prior to study enrollment.

Exclusion Criteria:

1. Concurrent administration of any other tumor therapy, including radiotherapy,
chemotherapy, immunotherapy.

2. Active uncontrolled infection.

3. Serious concomitant disorders that would compromise the safety of patient or
compromise the patient's ability to tolerate therapy.

4. MI within preceding 6 months or symptomatic heart disease including unstable angina,
congestive heart failure, or uncontrolled arrhythmia.

5. Significant neurological or mental disorder.

6. Second primary malignancy.

7. Pregnant or nursing.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To estimate the time to recurrence

Outcome Time Frame:

The interval from the date of randomization to the date to the date of the first objective evidence of recurrence or to the date of death, if before recurrence

Safety Issue:


Principal Investigator

Heung Tae Kim, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center, Korea


South Korea: Korea Food and Drug Administration (KFDA)

Study ID:




Start Date:

April 2006

Completion Date:

December 2012

Related Keywords:

  • Lung Cancer
  • Non small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms