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

Carcinoma of Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01731548
• Other study ID #: 2012-10-25
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: November 14, 2012
• Last updated: January 21, 2013
• Start date: June 2002
• Est. completion date: December 2016

Study information

• Verified date: January 2013
• Source: Zhejiang Cancer Hospital
• Contact: Ming Chen, MD
• Phone: +86 18758875572
• Email: gzcm[@]263.net
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma of Lung
• Limited Stage
• Lung Neoplasms
• Small Cell
• Small Cell Lung Carcinoma

Intervention

Radiation:
• hyperfractionated radiation therapy for both arms
1.5 Gy twice daily to 45 Gy in 30 fractions over 3 weeks for both arms

Locations

Country	Name	City	State
China	Sun Yat-Sen University, Cancer Center	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital	Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	local-regional progression		at least 6 months	Yes
Secondary	overall survival		at least 1 year	Yes