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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00616785 |
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Date of registration:
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14/02/2008 |
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Primary sponsor: |
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Public title:
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Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
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Scientific title:
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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 |
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Date of first enrolment:
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June 2007 |
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Target sample size:
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41 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00616785 |
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Study type:
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Interventional |
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Study design:
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Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Joo-Hang Kim, MD |
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Address:
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Telephone:
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+82-10-4507-6063 |
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Email:
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kjhang@yuhs.ac |
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Affiliation:
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Name:
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Joo-Hang Kim, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Yonsei University |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lung Cancer
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Intervention(s)
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Drug: cisplatin
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Drug: etoposide
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Drug: irinotecan hydrochloride
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Radiation: radiation therapy
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Primary Outcome(s)
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Feasibility of radiotherapy administered concurrently with etoposide and cisplatin chemotherapy
[Time Frame: Yes]
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Rate of local/regional control
[Time Frame: No]
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Rate of systemic disease control
[Time Frame: No]
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Secondary Outcome(s)
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Overall survival
[Time Frame: No]
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Progression-free survival
[Time Frame: No]
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Toxicity of irinotecan hydrochloride and cisplatin induction chemotherapy as assessed by NCI CTCAE v3.0
[Time Frame: Yes]
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Secondary ID(s)
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CDR0000584442
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YONSEI-4-2007-0120
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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