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Efficacy and safety of hypofractionated radiotherapy in lung cancer: a randomized controlled study

Efficacy and safety of hypofractionated radiotherapy in lung cancer: a randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102037
Enrollment
Unknown
Registered
2025-05-07
Start date
2025-05-07
Completion date
Unknown
Last updated
2025-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inoperable small cell and non-small cell lung cancer.

Interventions

Hypofractionated Treatment Group:Hypofractionated Treatment

Sponsors

The Second Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Able to provide written informed consent and understand and agree to follow the study requirements and assessment schedule. 2.Ages: 18 to 75 years old; 3.Patients with small cell and non-small cell lung cancer diagnosed as inoperable by pathological examination. 4.ECOG score: 0 - 2 points. 5.Expected survival period >= 3 months. 6.Patients should have measurable or evaluable target lesions. 7.Normal major organ function, meeting the following criteria:(1) The blood routine examination standards need to meet (no blood transfusion and blood products within 14 days, and no use of G-CSF and other hematopoietic stimulating factors for correction): a. HB>=100 g/L; b. ANC>=1.5×10^9/L; c. PLT>=100×10^9/L; (2) Biochemical examinations need to meet the following standards: a. TBIL 50 ml/min (Cockcroft-Gault formula); (3) Pulmonary function: FEV>=1L or >50% of the predicted value. 8.Women of childbearing age must ensure contraception during the study period. 9.Women of childbearing age must ensure contraception during the study period.

Exclusion criteria

Exclusion criteria: 1.Patients with pathological types and primary lesion sites that do not meet the inclusion criteria. 2.Patients who are not suitable to receive the radiotherapy regimen specified in the protocol. 3.Having any active malignant tumors within =5% within 1 month before treatment or other indicators showing severe malnutrition; 8.Pregnant or lactating women and women who refuse contraception during the treatment and observation period. 9.Individuals with personality or mental disorders, or those without or with limited civil conduct capacity. 10.Patients have participated in other anticancer drug clinical trials within 4 weeks; 11.Refuse or are unable to sign the informed consent form. 12.The investigator deems that there are other circumstances that may affect the conduct of the clinical study and the assessment of the study results.

Design outcomes

Primary

MeasureTime frame
Objective response rate;

Secondary

MeasureTime frame
3-year and 5-year survival rates.;Tumor Marker;Disease Control Rate;Quality of Life Score;Progression Free Survival;Adverse Reactions;

Countries

China

Contacts

Public ContactXixi Zhao

The Second Affiliated Hospital of Xi'an Jiaotong University

xixi_zhao@qq.com+86 29 87679323

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026