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A randomized controlled study of prophylactic irradiation on lymphatic drainage area of lung cancer by carbon ion rediotherapy with different dose distribution

A randomized controlled study of prophylactic irradiation on lymphatic drainage area of lung cancer by carbon ion rediotherapy with different dose distribution

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045611
Enrollment
Unknown
Registered
2021-04-19
Start date
2021-05-10
Completion date
Unknown
Last updated
2021-12-06

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

Conditions

Lung cancer

Interventions

Experimental group:the irradiation dose of 4GyE was given each time for 12 times
Control group:the irradiation dose of 3GyE was given each time for 16 times

Sponsors

Wuwei Tumor Hospital Heavy Ion Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Ability to follow the plan and sign an informed consent form; 2. There are complications that are not suitable for surgical resection or the patient refuses to undergo surgical treatment; 3. Between the ages of 18 and 80; patients with lung cancer diagnosed by bronchoscopy or lung biopsy; 4. Did not receive photon radiotherapy within half a year before this radiotherapy; 5. Exclude distant metastasis after imaging evaluation; 6. No acute severe infectious disease or active period of chronic infectious disease has been controlled; 7. The KPS score is greater than or equal to 60; 8. The general status of ECOG is scored 0-1; 9. The estimated survival period is greater than or equal to 12 months; 10. Sufficient organ function; 11. The location of the tumor needs to be able to meet the requirements of the radiation field layout; 12. The patient can lie supine or prone for more than 30 minutes in the position required for treatment.

Exclusion criteria

Exclusion criteria: 1. Complicated with other malignant tumors and has not been controlled; 2. The treatment area has received any radioactive seed implantation treatment; 3. The dose limit for organs at risk cannot reach the preset safe dose limit; 4. Metal prosthetic implants that may be interfered with by high-energy rays or may affect the dose of the radiation target area; 5. The physician believes that carbon ion radiotherapy will not benefit patients; 6. Combined with other diseases or other factors that may affect carbon ion therapy; 7. Accompanied by serious complications that may affect the progress of radiotherapy; 8. No capacity for civil conduct or limited capacity for civil conduct; 9. Circumstances considered by other doctors to be unsuitable to participate in clinical research.

Design outcomes

Primary

MeasureTime frame
Dose limiting toxicity;Local control rate;

Secondary

MeasureTime frame
Progression-free survival;3 years overall survival;

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