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

Randomized Phase II Study of 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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01710956

Enrollment

Registered

2012-10-19

Start date

2011-03-31

Completion date

2014-12-31

Last updated

2012-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Limited Disease Small Cell Lung Cancer

Keywords

concurrent chemoradiation in patients with limited disease small cell lung cancer

Brief summary

Non-small cell lung cancer

Interventions

RADIATIONArm 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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
progression free survival	5years after chemoradiotherapy

Countries

South Korea

Contacts

Primary ContactKwan Ho Cho, M.D.

kwancho@ncc.re.kr+82 31 920 1720

Backup ContactSung Ho Moon, M.D.

shmoon@ncc.re.kr+82 31 920 1726

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026