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Status unknownNCT00452881Updated Oct 25, 2010

Adjuvant Gemcitabine Plus Oxaliplatin Versus Gemcitabine Plus Cisplatin for Completely Resected Stage IB/II/IIIA NSCLC

A Phase 2 interventional study of gemcitabine and Oxaliplatin in Lung Cancer, sponsored by National Cancer Center, Korea. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-10-25.

Sponsored by National Cancer Center, Korea · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2010), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
151
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Oxaliplatin has a more manageable toxicity profile than cisplatin, with no renal toxicity and a lower incidence of hematological and gastrointestinal toxicities. The combination of gemcitabine-oxaliplatin is attractive in NSCLC patients as it may improve the therapeutic index. Given the potential advantages of oxaliplatin and th finding that the addition of chemotherapy improves survival in the postoperative adjuvant setting, we conduct a phase II trial to compare adjuvant gemcitabine-oxaliplatin with gemcitabine-cisplatin in patients with completely resected stage IB, II or IIIA NSCLC

Read the detailed description

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.

02

Conditions studied

  • Lung Cancer

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Keywords

  • Non-small cell lung cancer
  • adjuvant chemotherapy
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 151 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

National Cancer Center, Korea is the lead sponsor of 193 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
151 participants (actual)

Study arms

  • Experimental
    study arm

    GemOx

    Drug: gemcitabine · Drug: Oxaliplatin

  • Active comparator
    control arm

    GemCis

    Drug: gemcitabine · Drug: Cisplatin

Interventions

  • Druggemcitabine

    Gemcitabine1250mg/m2 iv on day 1 and 15, every 4weeks, maximum 4 cycles

  • DrugOxaliplatin

    Oxaliplatin 85mg/m2 iv on day 1 and 15, every 4 weeks, maximum 4 cycles

  • DrugCisplatin

    Cisplatin 40mg/m2 iv on day 1 and 15, every 4 weeks, maximum 4 cycles

06

What researchers measure

Primary outcomes

  1. Compare time to recurrence with these regimens

    Time frame: the first day of the treatment to date of the tumor recurrence

Secondary outcomes

  1. Compare to Overall survival with these regimens

    Time frame: the first day of treatment to death

  2. Compare to Toxicities with these regimens

    Time frame: the first day of treatment to the date that disease progression is reported

  3. - To define the patient population most at risk for disease recurrence

    Time frame: from the date of randomization to date of recurrence

  4. (tissue banking and blood sampling for analysis of predictive markers)

    Time frame: before treatment, obtained from the resected lung cancer specimen

  5. Compare quality of life as assessed by EORTC QLQ-C30, EORTC QLQ-LC13 with these regimens

    Time frame: before treatment and after each cycle

07

Study locations

1 site
  • National Cancer Center, Korea
    Goyang-si, Gyeonggi-do 411-769, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00452881
Lead sponsor
National Cancer Center, Korea
First posted
Mar 28, 2007
Start date
May 2006
Primary completion
Oct 2009
Completion
Dec 2014 (estimated)
Last update
Oct 25, 2010

Study contacts

Jae-Ill Zo, M.D.
principal investigator · National Cancer Center, Korea

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.

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Discussion

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