Lung CancerPhase 2NCT00452881
Adjuvant Gemcitabine Plus Oxaliplatin Versus Gemcitabine Plus Cisplatin for Completely Resected Stage IB/II/IIIA NSCLC
A Phase 2 study testing gemcitabine, Oxaliplatin and Cisplatin in people with Lung Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- gemcitabine, Oxaliplatin and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2006to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, 411-769
About this 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
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.
- Conditions
- Lung Cancer
- Being tested
- gemcitabine, Oxaliplatin, Cisplatin
- Keywords
- Non-small cell lung cancer, adjuvant chemotherapy
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemcitabineDrug
Gemcitabine1250mg/m2 iv on day 1 and 15, every 4weeks, maximum 4 cycles
OxaliplatinDrug
Oxaliplatin 85mg/m2 iv on day 1 and 15, every 4 weeks, maximum 4 cycles
CisplatinDrug
Cisplatin 40mg/m2 iv on day 1 and 15, every 4 weeks, maximum 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| study arm | Experimental | GemOx Receives: Drug: gemcitabine; Drug: Oxaliplatin |
| control arm | Active comparator | GemCis Receives: Drug: gemcitabine; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare time to recurrence with these regimens
Measured: the first day of the treatment to date of the tumor recurrence
Secondary outcomes (5)
Compare to Overall survival with these regimens
Measured: the first day of treatment to death
Compare to Toxicities with these regimens
Measured: the first day of treatment to the date that disease progression is reported
- To define the patient population most at risk for disease recurrence
Measured: from the date of randomization to date of recurrence
(tissue banking and blood sampling for analysis of predictive markers)
Measured: before treatment, obtained from the resected lung cancer specimen
Compare quality of life as assessed by EORTC QLQ-C30, EORTC QLQ-LC13 with these regimens
Measured: before treatment and after each cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2007 (estimated)
- Study startMay 2006
- Primary completionOct 2009
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Investigators
- Jae-Ill Zo, M.D., Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00452881
- Sponsor's protocol ID
- NCCCTS-05-158
- Status last verified
- Jul 2010
- First submitted
- 27 Mar 2007
- Last updated
- 25 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00452881
- Acronym / sponsor ID
- NCCCTS-05-158
- Conditions
- Lung Cancer
- Keywords
- Non-small cell lung cancer, adjuvant chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 151 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- May 2006
- Primary completion
- Oct 2009 (actual)
- Study completion
- Dec 2014 (estimated)
- First posted
- 28 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study arm | Experimental | Drug: gemcitabine, Drug: OxaliplatinGemOx |
| control arm | Active comparator | Drug: gemcitabine, Drug: CisplatinGemCis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gemcitabineGemcitabine1250mg/m2 iv on day 1 and 15, every 4weeks, maximum 4 cycles | Drug | control arm, study arm |
| OxaliplatinOxaliplatin 85mg/m2 iv on day 1 and 15, every 4 weeks, maximum 4 cycles | Drug | study arm |
| CisplatinCisplatin 40mg/m2 iv on day 1 and 15, every 4 weeks, maximum 4 cycles | Drug | control arm |
Primary outcome
Compare time to recurrence with these regimens
Time frame: the first day of the treatment to date of the tumor recurrence
5 secondary outcomes
Compare to Overall survival with these regimens
Time frame: the first day of treatment to death
Compare to Toxicities with these regimens
Time frame: the first day of treatment to the date that disease progression is reported
- To define the patient population most at risk for disease recurrence
Time frame: from the date of randomization to date of recurrence
(tissue banking and blood sampling for analysis of predictive markers)
Time frame: before treatment, obtained from the resected lung cancer specimen
Compare quality of life as assessed by EORTC QLQ-C30, EORTC QLQ-LC13 with these regimens
Time frame: before treatment and after each cycle
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jae-Ill Zo, M.D. principal investigator
National Cancer Center, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gemcitabine, Oxaliplatin and Cisplatin in people with Lung Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare time to recurrence with these regimens (time frame: the first day of the treatment to date of the tumor recurrence). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2010.