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
Phase 2
- Conditions
- Limited Disease Small Cell Lung Cancer
- Registration Number
- NCT01710956
- Lead Sponsor
- National Cancer Center, Korea
- Brief Summary
Non-small cell lung cancer
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 84
Inclusion Criteria
- Histologically or cytologically (if cannot be proven histologically, at least twice positive findings on fine needle aspiration or sputum cytology) confirmed SCLC
- 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
- T4 disease with malignant pleural effusion; N3 disease with contralateral hilum/supraclavicular lymph node invasion
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method progression free survival 5years after chemoradiotherapy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
National Cancer Canter, Korea
🇰🇷Ilsan-ro 323, Ilsandoung-gu, Goyang-si, Gyeonggi-do, Korea, Republic of