Back to results

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

Primary Purpose

Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

gemcitabine

Oxaliplatin

Cisplatin

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Non-small cell lung cancer, adjuvant chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologic diagnosis of non-small cell lung cancer.
Presence of pathological stage IB, II or IIIA, according to the American Joint Committee on Cancer (AJCC).
Completely resected tumor at NCC hospital.
No prior tumor therapy (radiotherapy, chemotherapy, immunotherapy, or any other type of tumor therapy).
Performance status of 0-1 on ECOG scale.
At least 18 years old
Patient compliance that allows adequate follow-up.
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.
Signed informed consent from patient or legal representative.
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:

Concurrent administration of any other tumor therapy, including radiotherapy, chemotherapy, immunotherapy.
Active uncontrolled infection.
Serious concomitant disorders that would compromise the safety of patient or compromise the patient's ability to tolerate therapy.
Second primary malignancy.
Significant neurological or mental disorder.
Pregnant or nursing.
MI within preceding 6 months or symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia

Sites / Locations

National Cancer Center, Korea

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

study arm

control arm

Arm Description

GemOx

GemCis

Outcomes

Primary Outcome Measures

Compare time to recurrence with these regimens

Secondary Outcome Measures

Compare to Overall survival with these regimens

Compare to Toxicities with these regimens

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

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

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

Full Information

NCT ID

NCT00452881

First Posted

March 27, 2007

Last Updated

October 22, 2010

Sponsor

National Cancer Center, Korea

1. Study Identification

Unique Protocol Identification Number

NCT00452881

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2010

Overall Recruitment Status

Unknown status

Study Start Date

May 2006 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

National Cancer Center, Korea

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

Non-small cell lung cancer, adjuvant chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

151 (Actual)

8. Arms, Groups, and Interventions

Arm Title

study arm

Arm Type

Experimental

Arm Description

GemOx

Arm Title

control arm

Arm Type

Active Comparator

Arm Description

GemCis

Intervention Type

Drug

Intervention Name(s)

gemcitabine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

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

Primary Outcome Measure Information:

Title

Compare time to recurrence with these regimens

Time Frame

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

Secondary Outcome Measure Information:

Title

Compare to Overall survival with these regimens

Time Frame

the first day of treatment to death

Title

Compare to Toxicities with these regimens

Time Frame

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

Title

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

Time Frame

from the date of randomization to date of recurrence

Title

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

Time Frame

before treatment, obtained from the resected lung cancer specimen

Title

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

Time Frame

before treatment and after each cycle

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologic diagnosis of non-small cell lung cancer. Presence of pathological stage IB, II or IIIA, according to the American Joint Committee on Cancer (AJCC). Completely resected tumor at NCC hospital. No prior tumor therapy (radiotherapy, chemotherapy, immunotherapy, or any other type of tumor therapy). Performance status of 0-1 on ECOG scale. At least 18 years old Patient compliance that allows adequate follow-up. 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. Signed informed consent from patient or legal representative. 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: Concurrent administration of any other tumor therapy, including radiotherapy, chemotherapy, immunotherapy. Active uncontrolled infection. Serious concomitant disorders that would compromise the safety of patient or compromise the patient's ability to tolerate therapy. Second primary malignancy. Significant neurological or mental disorder. Pregnant or nursing. MI within preceding 6 months or symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jae-Ill Zo, M.D.

Organizational Affiliation

National Cancer Center, Korea

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cancer Center, Korea

City

Goyang-si

State/Province

Gyeonggi-do

ZIP/Postal Code

411-769

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs