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

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.

Study Overview

• Status: Unknown
• Conditions: Carcinoma of Lung; Small Cell; Limited Stage
• Intervention / Treatment: Radiation: hyperfractionated radiation therapy for both arms

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Ming Chen, MD; Phone Number: +86 18758875572; Email: gzcm@263.net

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University, Cancer Center
      • Contact: Hui Liu, MD. PHD; Phone Number: 086-020-87343033; Email: liuhui@sysucc.org.cn
      • Contact: Yong Bao, MD; Phone Number: 086-020-87343504; Email: baoyong@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study arm; 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）	Radiation: hyperfractionated radiation therapy for both arms; 1.5 Gy twice daily to 45 Gy in 30 fractions over 3 weeks for both arms
Active Comparator: control arm; 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).	Radiation: hyperfractionated radiation therapy for both arms; 1.5 Gy twice daily to 45 Gy in 30 fractions over 3 weeks for both arms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
local-regional progression	at least 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival	at least 1 year

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Collaborators: Sun Yat-sen University
• Investigators: Principal Investigator: Ming Chen, MD, Zhejiang Cancer hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2002
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: November 14, 2012
• First Submitted That Met QC Criteria: November 14, 2012
• First Posted (Estimate): November 21, 2012

Study Record Updates

• Last Update Posted (Estimate): January 23, 2013
• Last Update Submitted That Met QC Criteria: January 21, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: 2012-10-25