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A Randomized Study of Involved-Field Irradiation Versus Elective Nodal Irradiation for LA-Nonsmall Cell Lung Cancer with Carbon Ion Radiotherapy

A Randomized Study of Involved-Field Irradiation Versus Elective Nodal Irradiation for LA-Nonsmall Cell Lung Cancer with Carbon Ion Radiotherapy

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054236
Enrollment
Unknown
Registered
2021-12-11
Start date
2021-12-15
Completion date
Unknown
Last updated
2022-11-14

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

Conditions

Lung cancer

Interventions

IFI (Involved-Field Irradiation) group:Involved field
EIN (Elective Nodal Irradiation) group:Elective field irradiation

Sponsors

Wuwei Cancer Hospital of Gansu Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years; 2. Histologically confirmed NSCLC; lymph node short diameter >= 10 mm,or FNA confirmed postive; 3. N0~2; 4. UICC TNM edition 8th, IIA~IIIB; 5. No prior RT for local lung lesion; 6. No prior chest RT; 7. Renal function, liver function and bone marrow function were normal (serum creatinine 9.5 g/dL; white blood cell count >= 3000/ml; platelet count >= 100,000/mL; 8. ECOG:0~2; 9. The expected survival >= 12 months; 10. Ability of subject to understand character and individual consequences of the clinical trial; 11. Written informed consent (must be available before enrolment in the trial).

Exclusion criteria

Exclusion criteria: 1. Patients who can't lie down for 30 minutes; 2. Tumor progression extensively involving the pleura; have cancerous pleural effusion; 3. Lose more than 20% of your body weight within six months; 4. Pregnancy (as confirmed by serum or urine ß-HCG test) or lactation; 5. Drug abuse or alcohol dependence; 6. HIV sufferers; 7. Having uncontrolled systemic, pulmonary or cardiac disease; 8. Serious comorbidities, including uncontrolled comorbidities (pulmonary insufficiency, cardiovascular, pulmonary, liver, kidney, diabetes, etc.), addiction, and/or mental illness, that prevent successful implementation of the trial programme; connective tissue diseases (e.g., scleroderma, systemic lupus) or a history of malignancy that might interfere with regimental treatment were excluded; 9. Implantation of a pacemaker or other metal prosthesis is enough to affect the recipient of radiotherapy; 10. Patients with poor compliance may not be able to complete treatment plans or receive required follow-up and examinations; 11. History of other malignancies (except cured skin cancer and stage 0 cervical cancer); 12. Received systemic immunotherapy or corticosteroid therapy; 13. Serum creatinine clearance < 30 ml/min; 14. There are contraindications to radiation therapy; 15. Participated in clinical trials of other drugs within 30 days prior to enrollment in this trial; 16. Incapacity for civil conduct or limited capacity for civil conduct; 17. Any medical history that, in the investigator's judgment, may interfere with trial results or increase patient risk; 18. Any conditions that the physician deems inappropriate for participation in the trial.

Design outcomes

Primary

MeasureTime frame
lymph node recurrence rate;local tumor control rate;acute and chronic toxicity;

Secondary

MeasureTime frame
progression-free survival,;specific survival overall;disease-free survival;

Countries

China

Contacts

Public ContactZhang Yanshan

Wuwei Cancer Hospital&Institute

13830510999@163.com+86 13830510999

Outcome results

None listed

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