Lung CancerPhase 2NCT00616785
Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
A Phase 2 study testing cisplatin, etoposide and irinotecan hydrochloride in people with Lung Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as irinotecan, cisplatin, and etoposide work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to damage tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- cisplatin, etoposide and irinotecan hydrochloride
- Type of treatment
- Surgery or procedure
- How many people
- 41 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2007to Nov 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Stage IIIA (N2) or IIIB disease
- Pathologic documentation of N2-3 mediastinal lymph nodes is encouraged but not required if nodal size is ≥ 1.5 cm in largest diameter
- No stage IIIB disease with malignant pleural effusion or superior sulcus tumor
- At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors
- Unresectable disease
- No known brain metastasis
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy > 3 months
- ANC ≥ 1,500/mm³
- Hemoglobin ≥ 9.0 g/dL (can be corrected by transfusion)
- Platelet count ≥ 100,000/mm³
- Creatinine < 1.5 mg/dL
- Total bilirubin < 2 times upper limit of normal (ULN)
- Transaminases < 3 times ULN
- Patient compliance and geographic proximity that allow adequate follow up
- No serious, uncontrolled systemic intercurrent illness (e.g., infections or poorly controlled diabetes)
- No history of significant neurological or mental disorder, including seizures or dementia
- No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
- No active cardiac disease not controlled by therapy
- No myocardial infarction within the past 12 months
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy for NSCLC
- No other concurrent systemic chemotherapy, investigational drug, or radiotherapy
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei Cancer Center at Yonsei University Medical Center
Seoul, 120-752
Joo-Hang Kim, MD, +82-10-4507-6063, kjhang@yuhs.ac
About this study
Official title: Phase II Trial Irinotecan and Cisplatin Induction Chemotherapy Followed by Radiotherapy Concurrently With Etoposide/Cisplatin in Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as irinotecan, cisplatin, and etoposide work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.
Read the detailed description
OBJECTIVES:
Primary
- To evaluate the efficacy of induction chemotherapy comprising irinotecan hydrochloride and cisplatin in patients with locally advanced, unresectable stage III non-small cell lung cancer.
- To evaluate the feasibility of radiotherapy administered concurrently with etoposide and cisplatin chemotherapy after induction chemotherapy in these patients.
Secondary
- To evaluate the toxicity of induction chemotherapy comprising irinotecan hydrochloride and cisplatin in these patients.
- To assess whether this induction chemotherapy regimen will improve patient survival when compared with outcomes from the predecessor study, SWOG-9019.
OUTLINE: Patients receive dose-dense induction chemotherapy comprising irinotecan hydrochloride IV and cisplatin IV on days 1 and 8. Treatment repeats every 21 days for up to 2 courses.
After completion of induction chemotherapy, patients undergo radiotherapy five days a week for approximately 7 weeks. Patients receive concurrent chemotherapy comprising cisplatin IV on days 1, 8, 29, and 36 and etoposide IV on days 1-5 and 29-33.
After completion of study therapy, patients are followed at 6 weeks.
- Conditions
- Lung Cancer
- Being tested
- cisplatin, etoposide, irinotecan hydrochloride, radiation therapy
- Keywords
- stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
- 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of local/regional control
Rate of systemic disease control
Feasibility of radiotherapy administered concurrently with etoposide and cisplatin chemotherapy
Secondary outcomes (3)
Toxicity of irinotecan hydrochloride and cisplatin induction chemotherapy as assessed by NCI CTCAE v3.0
Progression-free survival
Overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startJun 2007
- Primary completionNov 2010 (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.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Investigators
- Joo-Hang Kim, MD, Study chair, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616785
- Sponsor's protocol ID
- CDR0000584442
- Other IDs
- YONSEI-4-2007-0120
- Status last verified
- Sep 2008
- First submitted
- 14 Feb 2008
- Last updated
- 9 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial Irinotecan and Cisplatin Induction Chemotherapy Followed by Radiotherapy Concurrently With Etoposide/Cisplatin in Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00616785
- Acronym / sponsor ID
- CDR0000584442
- Conditions
- Lung Cancer
- Keywords
- stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Nov 2010 (estimated)
- First posted
- 15 Feb 2008 (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.
RATIONALE: Drugs used in chemotherapy, such as irinotecan, cisplatin, and etoposide work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.
Detailed description
OBJECTIVES:
Primary
- To evaluate the efficacy of induction chemotherapy comprising irinotecan hydrochloride and cisplatin in patients with locally advanced, unresectable stage III non-small cell lung cancer.
- To evaluate the feasibility of radiotherapy administered concurrently with etoposide and cisplatin chemotherapy after induction chemotherapy in these patients.
Secondary
- To evaluate the toxicity of induction chemotherapy comprising irinotecan hydrochloride and cisplatin in these patients.
- To assess whether this induction chemotherapy regimen will improve patient survival when compared with outcomes from the predecessor study, SWOG-9019.
OUTLINE: Patients receive dose-dense induction chemotherapy comprising irinotecan hydrochloride IV and cisplatin IV on days 1 and 8. Treatment repeats every 21 days for up to 2 courses.
After completion of induction chemotherapy, patients undergo radiotherapy five days a week for approximately 7 weeks. Patients receive concurrent chemotherapy comprising cisplatin IV on days 1, 8, 29, and 36 and etoposide IV on days 1-5 and 29-33.
After completion of study therapy, patients are followed at 6 weeks.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| cisplatin | Drug | – |
| etoposide | Drug | – |
| irinotecan hydrochloride | Drug | – |
| radiation therapy | Radiation | – |
Primary outcome
Rate of local/regional control
Rate of systemic disease control
Feasibility of radiotherapy administered concurrently with etoposide and cisplatin chemotherapy
3 secondary outcomes
Toxicity of irinotecan hydrochloride and cisplatin induction chemotherapy as assessed by NCI CTCAE v3.0
Progression-free survival
Overall survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2009.
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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.
Yonsei Cancer Center at Yonsei University Medical Center
Seoul, South Korea
Joo-Hang Kim, MD study chair
Yonsei University
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 cisplatin, etoposide and irinotecan hydrochloride in people with Lung Cancer, run by Yonsei University 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 9 Feb 2009. 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?
Rate of local/regional control. The study lists 3 primary outcomes in all. 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 9 Feb 2009.