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Lung CancerPhase 2NCT00398385

Gemcitabine and Cisplatin Before or After Surgery in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer

A Phase 2 study testing cisplatin, gemcitabine hydrochloride and adjuvant therapy in people with Lung Cancer, run by National Cancer Center, Korea at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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?
cisplatin, gemcitabine hydrochloride and adjuvant therapy
Type of treatment
Surgery or procedure
How many people
170 participants
Where
1 siteSouth Korea
Study dates
May 2005to Apr 2010
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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
  • Squamous cell or nonsquamous cell histology
  • Stage IB or II disease
  • Tumor amenable to curative surgical resection

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after completion of study therapy
  • Medical fitness must be adequate for radical NSCLC surgery
  • WBC ≥ 4,000/mm³
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 10 g/dL
  • Bilirubin normal
  • ALT and AST ≤ 2.5 times upper limit of normal
  • Creatinine ≤ 1.5 mg/dL
  • No second primary malignancy
  • No active uncontrolled infection
  • No concurrent serious disorder that would compromise patient safety or tolerance of study therapy
  • No significant neurological or mental disorder
  • No myocardial infarction within the past 6 months
  • No symptomatic heart disease, including any of the following:
  • Unstable angina
  • Congestive heart failure
  • Uncontrolled arrhythmia

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or anticancer therapy
  • No prior surgery for NSCLC
  • No prior or concurrent radiotherapy or immunotherapy (e.g., biologic response modifier)
  • No major surgery (other than biopsy) within the past 2 weeks
  • No other concurrent anticancer therapy
  • No other concurrent investigational agents

Trial locations and contacts

1 site in 1 country.

South Korea1 site, 1 recruiting

  • National Cancer Center - Korea

    Goyang, 410-769

    Heungtae T. Kim, MD, PhD, 82-31-920-1622, htkim@ncc.re.kr

    Recruiting

Other trials in South Korea

About this study

Official title: A Randomized Phase II Study of Preoperative Versus Postoperative Gemcitabine and Cisplatin for Patients With Stage IB-II Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving chemotherapy before surgery is more effective than giving it after surgery in treating non-small cell lung cancer.

PURPOSE: This randomized phase II trial is studying gemcitabine and cisplatin to compare how well they work when given before or after surgery in treating patients with stage I or stage II non-small cell lung cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the time to recurrence in patients with stage IB or II non-small cell lung cancer treated with neoadjuvant versus adjuvant gemcitabine hydrochloride and cisplatin.

Secondary

  • Compare overall survival of patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.
  • Compare quality of life of these patients.
  • Compare the complete resection rate with and without neoadjuvant gemcitabine hydrochloride and cisplatin.

OUTLINE: This is a randomized study. Patients are stratified by disease stage (IB vs II) and histology (squamous cell carcinoma vs nonsquamous cell carcinoma). Patients are randomized to 1 of 2 treatment arms.

  • Arm I (neoadjuvant chemotherapy): Patients receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV over 30 minutes on days 1 and 15. Treatment repeats every 4 weeks for up to 4 courses in the absence of disease recurrence or unacceptable toxicity. Within 8 weeks after initiating course 4 of chemotherapy, patients undergo complete surgical resection.
  • Arm II (adjuvant chemotherapy): Patients undergo complete surgical resection. Beginning within 8 weeks after complete surgical resection, patients receive gemcitabine hydrochloride IV and cisplatin IV as in arm I.

Quality of life is assessed at baseline and periodically for up to 5 years.

After completion of study therapy, patients are followed periodically for at least 5 years or until disease recurrence.

PROJECTED ACCRUAL: A total of 170 patients will be accrued for this study.

Conditions
Lung Cancer
Keywords
squamous cell lung cancer, adenocarcinoma of the lung, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer, large cell lung cancer, stage IB non-small cell lung cancer, stage IIA non-small cell lung cancer, stage IIB non-small cell lung cancer
Medical subject headings
Lung Neoplasms, Adenocarcinoma of Lung, Adenocarcinoma, Bronchiolo-Alveolar, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to recurrence

Secondary outcomes (6)

  1. Overall survival

  2. Toxicity

  3. Safety, in terms of frequency, severity, and relationship of adverse events, as assessed by NCI CTCAE v3.0

  4. Complete resection rate

  5. Quality of life as assessed by EORTC QLQ-C30 and EORTC QLQ-LC13 at baseline and periodically for 5 years

  6. Patient population most at risk for disease recurrence

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2006 (estimated)
  2. Study startMay 2005
  3. Primary completionApr 2010 (estimated)

Resources

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
Enrolment
170 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00398385
Sponsor's protocol ID
NCC-NCCCTS-05-122
Other IDs
CDR0000516823
Status last verified
Apr 2008
First submitted
9 Nov 2006
Last updated
12 Aug 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cisplatin, gemcitabine hydrochloride and adjuvant therapy 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?

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 12 Aug 2013. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to recurrence. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00398385.

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 12 Aug 2013.

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