To hear about similar clinical trials, please enter your email below
Trial Title:
A Prospective Randomized Study Comparing the Target Volume for Limited-stage Small Cell Lung Cancer
NCT ID:
NCT01731548
Condition:
Carcinoma of Lung
Small Cell
Limited Stage
Conditions: Official terms:
Small Cell Lung Carcinoma
Lung Neoplasms
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
hyperfractionated radiation therapy for both arms
Description:
1.5 Gy twice daily to 45 Gy in 30 fractions over 3 weeks for both arms
Arm group label:
control arm
Arm group label:
study arm
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:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-Sen University, Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Hui Liu, MD. PHD
Phone:
086-020-87343033
Email:
liuhui@sysucc.org.cn
Contact backup:
Last name:
Yong Bao, MD
Phone:
086-020-87343504
Email:
baoyong@sysucc.org.cn
Start date:
June 2002
Completion date:
December 2016
Lead sponsor:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Zhejiang Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01731548
