Once Daily Accelerated Fractionation With Concomitant Boost to the Gross Tumor Volume Compared With Twice Daily Hyperfractionation in Concurrent Chemoradiation in Patients With Limited Disease Small Cell Lung Cancer
NCT ID: NCT01710956
Last Updated: 2012-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
84 participants
INTERVENTIONAL
2011-03-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1(with twice-daily TRT)
Arm 1: with twice-daily thoracic radiotherapy/ Arm 2: with once-daily thoracic radiotherapy
Arm 1: with twice-daily thoracic radiotherapy daily 1.5gy/fr. bid, total 45gy(30fr during 3weeks) Arm 2: with once-daily thoracic radiotherapy daily 2.4gy/fr. qd, total 60gy(25fr during 5weeks)
Arm 2 (with once-daily TRT)
Arm 1: with twice-daily thoracic radiotherapy/ Arm 2: with once-daily thoracic radiotherapy
Arm 1: with twice-daily thoracic radiotherapy daily 1.5gy/fr. bid, total 45gy(30fr during 3weeks) Arm 2: with once-daily thoracic radiotherapy daily 2.4gy/fr. qd, total 60gy(25fr during 5weeks)
Interventions
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Arm 1: with twice-daily thoracic radiotherapy/ Arm 2: with once-daily thoracic radiotherapy
Arm 1: with twice-daily thoracic radiotherapy daily 1.5gy/fr. bid, total 45gy(30fr during 3weeks) Arm 2: with once-daily thoracic radiotherapy daily 2.4gy/fr. qd, total 60gy(25fr during 5weeks)
Eligibility Criteria
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Inclusion Criteria
* Limited stage (Clinical stage I-IIIb, lesion limited to one side of thorax, e.g. Excluding T4 disease with malignant pleural effusion or N3 disease with contralateral hilum/supraclavicular lymph node invasion).
* Measurable or assessable lesion
* Age over 18 years old
* Performance status (ECOG scale): 0\~2
* Adequate organ functions: ANC ≥ 1500/ul, PLT ≥ 100 x 103/u, Total Bilirubin ≤ 1.5 mg/dl, Creatinine ≤ 1.5 mg/dl
* Inclusion of tumor within the limited radiation field without significant loss of pulmonary function (confirmed by radiation oncologist)
* Sexually active fertile men and women using a contraceptive method
* Patients should sign a written informed consest before study entry
Exclusion Criteria
* Lesion with mixed small cell nonsmall cell feature (pathologically)
* prior chemotherapy or radiation therapy.
* Pericardial or pleural effusion on chest X-ray image regardless of cytological finding
* T4 disease with tumor invasion to great vessels, heart, trachea, or esophagus; Concerns about possible perforation by tumor necrosis
* Severe comorbidities such as cardiac disease with symptom, myocardiac infarction within 6 months, chronic obstructive pulmonary disease with FEV1 less than 1.0ℓ, or uncontrolled bronchospasm of unaffected lung
* With atelectasis that makes GTV unidentifiable
* Other primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 3 years ago without recurrence)
* Uncontrolled psychiatric disorder, serious head injury, chronic alcoholism, drug addiction and central nervous system disease
18 Years
ALL
No
Sponsors
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National Cancer Center, Korea
OTHER_GOV
Responsible Party
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Kwan Ho Cho
PI
Principal Investigators
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Kwan Ho Cho, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Center, Korea
Locations
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National Cancer Canter, Korea
Ilsan-ro 323, Ilsandoung-gu, Goyang-si, Gyeonggi-do, South Korea
National Cancer Canter, Korea
Ilsan-ro 323, Ilsandoung-gu, Goyang-si, Gyeonggi-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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Kwan Ho Cho, M.D.
Role: primary
Sung Ho Moon, M.D.
Role: backup
Kwan Ho Cho, M.D.
Role: primary
Sung Ho Moon, M.D.
Role: backup
Other Identifiers
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NCCCTS-11-531
Identifier Type: -
Identifier Source: org_study_id