Comparable Study of Different Thoracic Radiotherapy Regimens for Extensive Stage Small Cell Lung Cancer
- Conditions
- Carcinoma, Small CellLung Neoplasms
- Interventions
- Radiation: high-dose TRTRadiation: standard-dose TRT
- Registration Number
- NCT02675088
- Lead Sponsor
- Chinese Academy of Medical Sciences
- Brief Summary
Most patients with extensive stage small-cell lung cancer (ES-SCLC) who undergo chemotherapy, and prophylactic cranial irradiation, have persistent intrathoracic disease. A Dutch study recently proved that thoracic radiotherapy(TRT), using 30 Gy in 10 fractions of 3 Gy, could improve 2-year overall survival(OS) of this patient group compared with non-TRT group. But intrathoracic progression was still high, either with or without progression elsewhere, occurring in 43.7% in the TRT group. The ideal TRT regimen for ES-SCLC is undefined. Maybe higher dose can provide better local control(LC) and overall survival. In this study, the investigators propose to give an increased dose of TRT to determine whether higher dose will improve 2-year OS, LC and progression-free survival.
- Detailed Description
This is a multicenter, prospective, randomised phase III study. For patients with ES-SCLC who respond to chemotherapy after four to six cycles of standard chemotherapy (platinum etoposide), 45Gy/15F of thoracic radiotherapy will be used in experimental arm, while 30Gy/10F of thoracic radiotherapy will be used in the control arm. Both survival and toxicity of the two arms will be observed and compared.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 186
- 18 - 70 years old, ECOG 0-2.
- Patients with histologically or cytologically proved small cell lung cancer.
- Extensive stage small-cell lung cancer (ES-SCLC), was characterized by tumors beyond the hemithorax, hilar, mediastinal, and supraclavicular nodes. According to 2007 AJCC cancer staging 7th edition, stage I-IIIB with lung metastases and stage IV should be defined as LD.
- Has 1-4 extracranial metastatic lesions.
- No brain or central nervous system (CNS) metastases.
- No prior history of anti-tumor treatment.
- Response after 4 to 6 cycles of EP-based chemotherapy within the past 4 weeks.
- No severe internal diseases and no organ dysfunction.
- Written informed consent provided.
- Malignant tumors of other sites. Non melanoma skin cancer and Cervical carcinoma in situ were not included if curable.
- Active heart disease or acute myocardial infarction happen in six months.
- Psychiatric history.
- Pregnant woman or woman need to breast feed or woman with positive chorionic gonadotrophin (HCG).
- Uncontrolled diabetes or hypertension.
- Interstitial pneumonia or Active pulmonary fibrosis.
- Acute bacterial or fungal infection.
- Oral or intravenous use of steroids.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description high-dose TRT high-dose TRT high-dose thoracic radiotherapy X-ray RT standard-dose TRT standard-dose TRT standard-dose thoracic radiotherapy XRT
- Primary Outcome Measures
Name Time Method overall survival 2 years The time interval between diagnosis and death
- Secondary Outcome Measures
Name Time Method Incidence of tumor recurrence in local or regional area 2 years Number of patients experienceing recurrences in local or regional area divided by number of all enrolled patients
Incidence of radiotherapy and chemotherapy induced toxicities assessed by CTCAE v 4.0 2 years Number of patients experienceing any toxicities induced by radiotherapy or chemotherapy divided by number of all enrolled patients
progression-free survival 2 years The time interval between diagnosis and disease progression
Trial Locations
- Locations (2)
Cancer Insititute and Hosiptal of Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China