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A Randomized Phase II Study Adjuvant Gemcitabine And Oxaliplatin Versus Gemcitabine and Cisplatin for Completely Resected Stage IB, II or IIIA Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

A Randomized Phase II Study Adjuvant Gemcitabine And Oxaliplatin Versus Gemcitabine and Cisplatin for Completely Resected Stage IB, II or IIIA Non-Small Cell Lung Cancer


This study is a randomized phase II study. Patients are randomized to 1 of 2 treatment arms:
patients receive adjuvant chemotherapy with gemcitabine-oxaliplatin or
gemcitabine-cisplatin. Chemotherapy should be started within 8 weeks after complete surgical
resection. Patients are followed every 3 months for 2 years, every 6 months for 3 years.

Gemcitabine-Oxaliplatin (GemOx) chemotherapy:

Gemcitabine (1,250 mg/m2)+Oxaliplatin (85 mg/m2) is given on day 1 and 15 q 4weeks. maximum
4 cycles.

Gemcitabine-Cisplatin (GemCis) chemotherapy:

Gemcitabine (1,250 mg/m2) + Cisplatin (40 mg/m2) is given on day 1 and 15 q 4weeks. maximum
4 cycles.


Inclusion Criteria:



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

2. Presence of pathological stage IB, II or IIIA, according to the American Joint
Committee on Cancer (AJCC).

3. Completely resected tumor at NCC hospital.

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

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

6. At least 18 years old

7. Patient compliance that allows adequate follow-up.

8. 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 ³ 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.

9. Signed informed consent from patient or legal representative.

10. 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. Second primary malignancy.

5. Significant neurological or mental disorder.

6. Pregnant or nursing.

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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Compare time to recurrence with these regimens

Outcome Time Frame:

the first day of the treatment to date of the tumor recurrence

Safety Issue:

No

Principal Investigator

Jae-Ill Zo, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center, Korea

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

NCCCTS-05-158

NCT ID:

NCT00452881

Start Date:

May 2006

Completion Date:

December 2014

Related Keywords:

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

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