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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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sun Yat-sen University
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.