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

This study is currently recruiting participants.
Verified January 2013 by Zhejiang Cancer Hospital
Sponsor:
Collaborator:
Sun Yat-sen University
Information provided by (Responsible Party):
Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01731548
First received: November 14, 2012
Last updated: January 21, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Carcinoma of Lung
Small Cell
Limited Stage
 Radiation: hyperfractionated radiation therapy for both arms
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Omitting Elective Nodal Irradiation and Irradiating Post-induction Versus Pre-induction Chemotherapy Tumor Extent for Limited-stage Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Zhejiang Cancer Hospital:

Primary Outcome Measures:
  • local-regional progression [ Time Frame: at least 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: at least 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: June 2002
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731548

Contacts
Contact: Ming Chen, MD +86 18758875572 gzcm@263.net

Locations
China, Guangdong
Sun Yat-Sen University, Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Hui Liu, MD. PHD     086-020-87343033     liuhui@sysucc.org.cn    
Contact: Yong Bao, MD     086-020-87343504     baoyong@sysucc.org.cn    
Sponsors and Collaborators
Zhejiang Cancer Hospital
Sun Yat-sen University
Investigators
Principal Investigator: Ming Chen, MD Zhejiang Cancer Hospital
  More Information

No publications provided

Responsible Party: Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT01731548     History of Changes
Other Study ID Numbers: 2012-10-25
Study First Received: November 14, 2012
Last Updated: January 21, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Lung Neoplasms
Small Cell Lung Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on June 17, 2013