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

Study Timeline

• Study Start: 2011-03
• Status Verified: 2012-10
• Study First Submitted: 2012-10-16
• Study First Submitted QC: 2012-10-17
• Last Update Submitted: 2012-10-17
• Study First Posted: 2012-10-19
• Last Update Posted: 2012-10-19
• Primary Completion: 2014-12
• Study Completion: 2014-12

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

Trial Locations

Locations (1)

National Cancer Canter, Korea; 🇰🇷 Ilsan-ro 323, Ilsandoung-gu, Goyang-si, Gyeonggi-do, Korea, Republic of

National Cancer Canter, Korea

🇰🇷Ilsan-ro 323, Ilsandoung-gu, Goyang-si, Gyeonggi-do, Korea, Republic of

Kwan Ho Cho, M.D.

Contact

+82 31 920 1720

kwancho@ncc.re.kr

Sung Ho Moon, M.D.

Sub Investigator

Jin Soo Lee, M.D.

Sub Investigator

Heung Tae Kim, M.D.

Sub Investigator

Ji Youn Han, M.D.

Sub Investigator

Tak Yun, M.D

Sub Investigator

Young Joo Lee, M.D.

Sub Investigator

Geon Kook Lee, M.D.

Sub Investigator

Hyae Young Kim, M.D.

Sub Investigator

Byung Ho Nam, Statistician

Sub Investigator