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

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ClinicalTrials.gov Identifier: NCT01731548
Recruitment Status : Unknown
Verified January 2013 by Zhejiang Cancer Hospital.
Recruitment status was:  Recruiting
First Posted : November 21, 2012
Last Update Posted : January 23, 2013
Sponsor:
Collaborator:
Sun Yat-sen University
Information provided by (Responsible Party):
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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2002
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

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

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



Primary Outcome Measures :
  1. local-regional progression [ Time Frame: at least 6 months ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: at least 1 year ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT01731548     History of Changes
Other Study ID Numbers: 2012-10-25
First Posted: November 21, 2012    Key Record Dates
Last Update Posted: January 23, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Small Cell Lung Carcinoma
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases