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A Prospective Randomized Study Comparing the Target Volume for Limited-stage Small Cell Lung Cancer
Conditions
Carcinoma of Lung - Small Cell - Limited Stage
Conditions: official terms
Lung Neoplasms - Small Cell Lung Carcinoma
Study Type
Interventional
Study Phase
Phase 2/Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: hyperfractionated radiation therapy for both arms
Type: Radiation
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
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.
- 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.
Location
Sun Yat-Sen University, Cancer Center
Guangzhou, Guangdong, China
Status: Recruiting
Contact: Hui Liu, MD. PHD - 086-020-87343033 - liuhui@sysucc.org.cn
Start Date
June 2002
Completion Date
December 2016
Sponsors
Zhejiang Cancer Hospital
Source
Zhejiang Cancer Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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