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Early primary tumor stereotactic body radiotherapy after 1-month TKI for first line treatment of patients with advanced non-small lung cancer of harbouring EGFR mutations: A multicenter, open-label, phase II trial

Early primary tumor stereotactic body radiotherapy after 1-month TKI for first line treatment of patients with advanced non-small lung cancer of harbouring EGFR mutations: A multicenter, open-label, phase II trial

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIN-17013920
Enrollment
Unknown
Registered
2017-12-14
Start date
2016-10-01
Completion date
Unknown
Last updated
2017-12-18

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

Conditions

Advanced non-small lung cancer of harbouring EGFR mutations

Interventions

1:SBRT

Sponsors

Taizhou Hospital of Zhejiang Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Inclusive criteria: 1) A histopathologically or cytologically proven non-small cell lung cancer(NSCLC) and harbouring EGFR mutations tested by drug resistant gene detection; 2) There were 2~5 lesions that can be measured as RECIST standard; 3) All patients were stage IV,as UICC (Version 8). The maximum diameter of every lung lesion was no more than 5cm; 4) Aged 18 to 85 years old; 5) ECOG was 0 or 1,KPS score > 60; 6) The tumor had not infiltrated into the trachea or the big blood vessels; 7) No patients had received chemotherapy , chest radiotherapy or other biological therapy; 8) Hb=100g/L, Plt=100×10^9/L, NEUT=1.5×10^9/L; 9) SB=1.5×UNLAST (SGOT), ALT (SGPT)=2.5×UNL, ALP=5xUNL; 10) Without uncontrolled lung infection, pleural effusion and interstitial pneumonia; 11) FEV1>0.8L. All patients must sign the consent form.

Exclusion criteria

Exclusion criteria: 1) Lung cancer operation ,chest radiotherapy or chemotherapy was performed,before the study; 2) Patients had psychiatric impairments which will prevent completion of the protocol therapy; 3) Poor compliance of patients.Patients had major medical illnesses which will prevent completion of the protocol therapy; 4) Patients had symptomatic intracranial metastatic tumor; 5)Patients had other uncured malignancies; 6) Three to four allergic reactions to the treatment; 7) Patients had participated in other clinical trials in 30 days; 8) The patients which researchers believed that they should be excluded from this study.

Design outcomes

Primary

MeasureTime frame
progression-free survival;

Secondary

MeasureTime frame
overall survival;

Countries

China

Contacts

Public ContactYang Haihua

Taizhou Hospital

yhh93181@hotmail.com+86 13819639006

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026