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

Phase 2

• Conditions: Carcinoma of Lung; Small Cell; Limited Stage
• Interventions: Radiation: hyperfractionated radiation therapy for both arms

• Registration Number: NCT01731548
• Lead Sponsor: Zhejiang Cancer Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2012-11-14
• Study First Submitted QC: 2012-11-14
• Study First Posted: 2012-11-21
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-21
• Last Update Posted: 2013-01-23
• Primary Completion: 2014-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study arm	hyperfractionated radiation therapy for both arms	For patients who are randomized to study arm, (i.e. to irradiate the post-chemotherapy tumor extent) the clinical target volume-tumor (CTV-T) includes the post-chemotherapy gross tumor volume-tumor (GTV-T) with a margin of 0.8 cm. Chemotherapy includes etoposide 100mg/m2 d1-d3 combine with cisplatin 80mg/m2 d1 at 21-day interval for 4 cycles. Radiotherapy will be administered with cycle 3 chemotherapy（1.5 Gy twice daily to 45 Gy in 30 fractions over 3 weeks）
control arm	hyperfractionated radiation therapy for both arms	For patients who are randomized to control arm, (i.e. to irradiate the pre-chemotherapy tumor extent) the clinical target volume-tumor (CTV-T) includes the pre-chemotherapy gross tumor volume-tumor (GTV-T) with a margin of 0.8 cm. Chemotherapy includes etoposide 100mg/m2 d1-d3 combine with cisplatin 80mg/m2 d1 at 21-day interval for 4 cycles. Radiotherapy will be administered with cycle 3 chemotherapy (1.5 Gy twice daily to 45 Gy in 30 fractions over 3 weeks).

Primary Outcome Measures

Name	Time	Method
local-regional progression	at least 6 months

Secondary Outcome Measures

Name	Time	Method
overall survival	at least 1 year

Trial Locations

Locations (1)

Sun Yat-Sen University, Cancer Center; 🇨🇳 Guangzhou, Guangdong, China