SCLC Clinical Trial
Official title:
Phase III Randomized Study of Induction Chemotherapy Followed By Accelerated Hypofractionated vs. Conventionally Fractionated Concurrent Chemo-radiotherapy for Limited Stage Small Cell Lung Cancer.
This protocol is a phase III randomized controlled trial (RCT) evaluating the efficacy of induction chemotherapy followed by accelerated hypofractionated vs. conventionally fractionated concurrent chemo-radiotherapy for limited-stage small cell lung cancer.
Status | Recruiting |
Enrollment | 266 |
Est. completion date | December 2023 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Histologically or cytologically confirmed SCLC. - Male or female, aged 18-70 years. - ECOG performance status 0 to 2. - Limited-stage SCLC was defined as disease confined to one hemithorax and hilar,mediastinal, or supraclavicular nodes without pleural effusion, which can be safely encompassed within a tolerable radiation field. - No prior thoracic RT. - Weight loss in six months less than or equal to five percent. - FEV1 greater than 0.75L. - No severe internal diseases and no organ dysfunction. - No prior history of any tumor. - Skin test of CT contrast agents was negative. - Had received 1-6 cycles of VP16 plus DDP/carboplatin. - Voluntarily participated in this study and signed the informed consent form by himself or his agent. Had good compliance with the study procedures, and can cooperate with the relevant examination, treatment and follow-up. Exclusion Criteria: - Other tumor history(Except skin cancer/breast cancer/oral cancer/cervical cancer with expected lifespan more than or equal to 3 months). - Multiple primary lung cancer. - Any unstable systemic disease, including active infection, uncontrolled high blood pressure, unstable angina, newly observed angina pectoris within the past 3 months, congestive heart failure (New York heart association (NYHA) class II or higher), myocardial infarction onset six months before included into the group, and severe arrhythmia, liver, kidney, or metabolic disease in need of drug therapy. Human immunodeficiency virus (HIV) infection. - Women in pregnancy or lactation . - Patients with mental illness, considered as "can't fully understand the issues of this research". - Had received other chemotherapy regimens,any radiotherapy or TKI. - Refuse to write informed consent. |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Chest Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Chest Hospital |
China,
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* Note: There are 26 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival | 2 years | ||
Secondary | Progress Free Survival | 2 years | ||
Secondary | Treatment-related adverse event | 1 years | ||
Secondary | Locoregional recurrence-free survival | 2 years |
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