NCT04212052CompletedPhase 2
Split-course Hypofractionated Radiotherapy With Concurrent Chemotherapy in Locally Advanced Non-small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 15 Mar 2024
Brief summary (registry, in English)
This Phase II study is to determine the efficacy of split-course thoracic radiotherapy plus concurrent chemotherapy with or without consolidation immunotherapy for patients with local advanced non-small cell lung cancer.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 104 (actual)
- First submitted
- 24 Dec 2019
- Start date
- 1 Jul 2020
- Primary completion date
- 1 Jan 2023
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Lung cancer
- NCT number
- NCT04212052
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 104
- From 1 Jul 2020 to the primary completion date, 1 Jan 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous or recent another malignancy, except nonmelanoma skin cancer or cervical cancer in situ
- Contraindication for chemotherapy
- Women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose
- Addicted in drugs or alcohol, AIDS patients
Other illness
- Malignant pleural or pericardial effusion.
- Tendency of hemorrhage
- Uncontrollable seizure or psychotic patients without self-control ability
- Severe allergy or idiosyncrasy
Other
- Women who has the probability of pregnancy without contraception
- In other clinical trials within 30 days
- Not suitable for this study judged by researchers
Who the study is looking for
- Histologically confirmed non-small cell lung cancer (NSCLC) by bronchoscopy, CT-guided biopsy, and endobronchial ultrasonography
- Unresectable stage III disease based on the seventh edition of the TNM (tumor, node, metastases) staging system proposed by the American Joint Committee on Cancer
- Measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
- Charlson Comorbidity Index score ≤4
- Previously treated with chemotherapy or treatment-naive
- No previous chest radiotherapy, immunotherapy or biotherapy
- Hemoglobin≥10 mg/dL, platelet≥100000/μL,absolute neutrophil count ≥1500/μL
- Serum creatinine ≤1.25 times the upper normal limit(UNL), or creatinine clearance≥60 ml/min
- Bilirubin ≤1.5 times UNL, AST(SGOT)≤2.5 times UNL ,ALT(SGPT)≤2.5 times UNL,alkaline phosphatase ≤5 times UNL
- CB6 within normal limits
- patients and their family signed the informed consents
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.