Adjuvant Gemcitabine Plus Oxaliplatin vs. Gemcitabine Plus Cisplatin for Completely Resected Stage IB/II/IIIA NSCLC - Full Text View

Sponsored by:	National Cancer Center, Korea
Information provided by:	National Cancer Center, Korea
ClinicalTrials.gov Identifier:	NCT00452881

Purpose

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

Condition	Intervention	Phase
Lung Cancer	Drug: gemcitabine Drug: Oxaliplatin Drug: Cisplatin	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Oxaliplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:

Compare time to recurrence with these regimens [ Time Frame: the first day of the treatment to date of the tumor recurrence ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compare to Overall survival with these regimens [ Time Frame: the first day of treatment to death ] [ Designated as safety issue: No ]
Compare to Toxicities with these regimens [ Time Frame: the first day of treatment to the date that disease progression is reported ] [ Designated as safety issue: No ]
- To define the patient population most at risk for disease recurrence [ Time Frame: from the date of randomization to date of recurrence ] [ Designated as safety issue: No ]
(tissue banking and blood sampling for analysis of predictive markers) [ Time Frame: before treatment, obtained from the resected lung cancer specimen ] [ Designated as safety issue: No ]
Compare quality of life as assessed by EORTC QLQ-C30, EORTC QLQ-LC13 with these regimens [ Time Frame: before treatment and after each cycle ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	May 2006
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental GemOx	Drug: gemcitabine Gemcitabine1250mg/m2 iv on day 1 and 15, every 4weeks, maximum 4 cycles Drug: Oxaliplatin Oxaliplatin 85mg/m2 iv on day 1 and 15, every 4 weeks, maximum 4 cycles
2: Active Comparator GemCis	Drug: Cisplatin Cisplatin 40mg/m2 iv on day 1 and 15, every 4 weeks, maximum 4 cycles

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00452881

Contacts

Contact: Heung Tae Kim, M.D.

+82-31-920-1602

htkim@ncc.re.kr

Locations

Korea, Republic of, Gyeonggi-do
National Cancer Center, Korea	Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 411-769
Contact: Heung Tae Kim, M.D. +82-31-920-1602 htkim@ncc.re.kr
Sub-Investigator: Jong Mog Lee, M.D.
Sub-Investigator: Mun Soo Kim, M.D.
Sub-Investigator: Hyun Sung Lee, M.D.
Sub-Investigator: Jin Soo Lee, M.D.
Sub-Investigator: Ji-Youn Han, M.D.
Sub-Investigator: Bin Hwangbo, M.D.
Sub-Investigator: Hee Seok Lee, M.D.
Sub-Investigator: Hyae Young Kim, M.D.
Sub-Investigator: Geon Kook Lee, M.D.
Sub-Investigator: Moon Woo Seong, M.D.
Sub-Investigator: Sang Min Park, M.D.
Sub-Investigator: Tak Yun, M.D.

Sponsors and Collaborators

National Cancer Center, Korea

Investigators

Principal Investigator:

Jae-Ill Zo, M.D.

National Cancer Center, Korea

More Information

No publications provided

Responsible Party:	National Cancer Center, Korea ( Heung Tae Kim )
Study ID Numbers:	NCCCTS-05-158
Study First Received:	March 27, 2007
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00452881 History of Changes
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by National Cancer Center, Korea:

Non-small cell lung cancer
adjuvant chemotherapy

Study placed in the following topic categories:

Antimetabolites
Thoracic Neoplasms
Anti-Infective Agents
Immunologic Factors
Adjuvants, Immunologic
Immunosuppressive Agents
Antiviral Agents
Carcinoma
Oxaliplatin

Respiratory Tract Diseases
Cisplatin
Radiation-Sensitizing Agents
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Oxaliplatin
Neoplasms by Site
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Therapeutic Uses

Gemcitabine
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 10, 2009