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Prospective phase II clinical study of increasing the dose of carbon ion radiotherapy in small cell lung cancer using an isotoxic dose prescription

Prospective phase II clinical study of increasing the dose of carbon ion radiotherapy in small cell lung cancer using an isotoxic dose prescription

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052807
Enrollment
Unknown
Registered
2021-11-05
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-08-16

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

Conditions

Small cell lung cancer

Interventions

Therapy group:Carbon ion irradiation and drug therapy

Sponsors

Wuwei Tumor Hospital Heavy Ion Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 80 years; 2. Pathology confirmed small cell lung cancer; 3. Local radiotherapy of lung lesions was not performed in the patients with the limited-stage; 4. Have not had chest radiation therapy; 5. Renal function, liver function and bone marrow function are basically normal(serum creatinine 9.5 g/dL; WBC >= 3000/mL; PLT >= 100000/mL); 6. ECOG general status score less than or equal to 2; 7. The anticipated survival will be >= 6 months; 8. Informed consent was signed by the patient or his/her legal representative before radiotherapy.

Exclusion criteria

Exclusion criteria: 1. Patients cant hold their positions for more than 30 minutes; 2. Tumor progression extensively involving the pleura and cancerous pleural effusion; 3. Lose more than 20% of body weight within six months; 4. During pregnancy(confirmed by serum or urine beta-HCG test) or lactation; 5. Drug abuse or alcohol dependence; 6. AIDS; 7. With uncontrolled systemic or pulmonary or cardiac disease; 8. With serious comorbidities that preclude the successful implementation of the trial protocol, including uncontrolled comorbidities (pulmonary insufficiency, cardiovascular, lung, liver, kidney, diabetes, etc.), addiction and/or mental illness; 9. Implantation of a pacemaker or other metal prosthesis can be enough to affect the recipient of radiation therapy; 10. Patients with poor compliance, including those who may not be able to complete treatment plans or receive required follow-up and examinations; 11. has a history of other malignancies(skin cancer and stage 0 cervical cancer have been cured are excluded); 12. Systemic immunotherapy or corticosteroid therapy; 13. Serum creatinine clearance < 30 mL/minutes; 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
Progression-free survival;Local control rate;Objective response rate;Incidence of toxic reaction;

Secondary

MeasureTime frame
Failure mode of tumor treatment;Overall survival;Relationship between toxicity and dose/volume of irradiated organs at risk;

Countries

China

Contacts

Public ContactZhang Yanshan

Wuwei Tumor Hospital Heavy Ion Center

13830510999@163.com+86 13830510999

Outcome results

None listed

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