Clinical trial · Interventional
Hypofractionated Radiotherapy Followed by Hypo-boost for Local Advanced NSCLC
Hypofractionated Radiotherapy Followed by Hypofractionated Boost With Weekly Concurrent Chemotherapy for Unresectable Stage III Non-Small Cell Lung Cancer: A Prospective, Single Arm Phase II Study
NCT03900117CI-TRIAL-00061749completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective is to assess the safety and efficacy of hypofractionated radiotherapy followed by hypo-boost combined with concurrent weekly chemotherapy in unresectable LA-NSCLC patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| concurrent chemotherapy | Drug | — | UNRESOLVED |
| split-course radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- split-course radiotherapy
- description
- The radiotherapy is delivered using simultaneous integrated boost (SIB)-intensity-modulated radiotherapy (IMRT). Patients are irradiation at a palliative dose at the initial course: 40Gy/10f to gross tumor. The disease is re-evaluated one month after the end of the initial course using CT. The patient who achieved a partial remission according to the RECIST criteria and had a recovery of lung function should get the additional boost. At the second course, the tumor is re-simulated. The residual tumor was then treated with the second course of radiotherapy. A dose of 28Gy/7f is delivered to the residue tumor. Concurrent chemotherapy consists of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration.
- interventionNames
- Radiation: split-course radiotherapy
- Drug: concurrent chemotherapy
Primary outcomes (1)
- measure
- progression-free survival
- timeFrame
- 3 years
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologic confirmation of NSCLC. * Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. * Unresectable phase IIIA(N2) and IIIB lung cancer confirmed by PET/CT, CT or MRI. * Whole lung V20\>=35% when giving 60Gy which is the minimum dose of radical irradiation. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * 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 * FEV1 \>0.8 L * CB6 within normal limits * patients and their family signed the informed consents Exclusion Criteria: * Previous or recent another malignancy, except nonmelanoma skin cancer or cervical cancer in situ * Contraindication for chemotherapy * Malignant pleural or pericardial effusion. * Women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose * Women who has the probability of pregnancy without contraception * Tendency of hemorrhage * In other clinical trials within 30 days * Addicted in drugs or alcohol, AIDS patients * Uncontrollable seizure or psychotic patients without self-control ability * Severe allergy or idiosyncrasy * Not suitable for this study judged by researchers
References
Publications (38)
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