A Prospective Randomized Study Comparing the Target Volume for Limited-stage Small Cell Lung Cancer

Omitting Elective Nodal Irradiation and Irradiating Post-induction Versus Pre-induction Chemotherapy Tumor Extent for Limited-stage Small Cell Lung Cancer

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01731548

Enrollment

500

Registered

2012-11-21

Start date

2002-06-30

Completion date

2016-12-31

Last updated

2013-01-23

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

Conditions

Carcinoma of Lung, Limited Stage, Small Cell

Brief summary

We hypothesized that the local control for both arms were not statistically significant, when irradiation to the post-induction chemotherapy tumor volume is compared with irradiation to the pre-induction chemotherapy tumor volume.While elective nodal irradiation will be omitted for both arms.

Interventions

RADIATIONhyperfractionated radiation therapy for both arms

1.5 Gy twice daily to 45 Gy in 30 fractions over 3 weeks for both arms

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Patients were eligible if they had histologic or cytologic verification of small cell lung cancer (SCLC) and were radiographically confirmed limited-stage * Patients with contralateral mediastinal and ipsilateral supraclavicular lymphadenopathy were also included. * The patients should be between 18 and 75 years old without previous thoracic radiotherapy, chemotherapy or biotherapy. * Karnofsky performance status was ≥ 80. * Forced expiratory volume at 1 second (FEV1) ≥ 1 L. * Had measurable or assessable disease. * Neutrophilic granulocyte ≥ 1.5×109/L, haemoglobin ≥ 100 g/L, platelet count ≥ 100×109/L. * Serum creatine and bilirubin \< 1.5 × the upper normal limit (UNL), aminotransferase \< 2 × UNL. * Weight loss was less than 10% within 6 months before diagnosis. * Written informed consent was required from all patients.

Exclusion criteria

* Patients were ineligible if they had a history of other malignant diseases except for non-melanomatous skin cancer and carcinoma in situ of the cervix, or any contraindications for chemoradiotherapy, malignant pleural and/or pericardial effusion.

Design outcomes

Primary

Measure	Time frame
local-regional progression	at least 6 months

Secondary

Measure	Time frame
overall survival	at least 1 year

Countries

China

Contacts

Primary ContactMing Chen, MD

gzcm@263.net+86 18758875572

Outcome results

None listed

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