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A single center randomized controlled clinical study comparing the incidence of radiation pneumonia between intensity modulated radiotherapy and helical tomotherapy

A single center randomized controlled clinical study comparing the incidence of radiation pneumonia between intensity modulated radiotherapy and helical tomotherapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056025
Enrollment
Unknown
Registered
2022-01-31
Start date
2022-02-08
Completion date
Unknown
Last updated
2024-08-05

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

Conditions

esophageal cancer and lung cancer

Interventions

A:Tomotherapy
B:IMRT (Intensity-modulated radiotherapy)

Sponsors

Department of Oncology, the Second Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Histologically proven malignant tumor of esophagus and lung. 2. Life expectancy 3 months or longer; 3. KPS score >=70; 4. Be tolerated with radiotherapy; 5. Without autoimmune disease; 6. Adequate hematologic and end organ function, defined by the following laboratory results: Hemoglobin >=100g/L, ANC >=1.5 x 10^9/L without granulocyte colony-stimulating factor support, Platelet count >= 100 x 10^9/L; Serum bilirubin =60ml/min, urea nitrogen = 18 years.

Exclusion criteria

Exclusion criteria: 1. Prior conventional radiotherapy for esophageal cancer and lung cancer; 2. Patients with interstitial lung disease affecting daily life; 3. Treatment with any other investigational agent or participation in another clinical trial; 4. Malignancies other than esophageal cancer/lung cancer within 5 years prior to randomization; 5. History of any systemic diseases including: active infections, uncontrolled hypertension, congestive heart-failure, myocardial infarction, severe arrhythmia, liver, kidney or metabolic diseases. 6. Subjects with active chronic hepatitis B or active hepatitis C. Subjects with positive HBsAg or HCV antibody in the screening period must undergo further quantitative detection of hepatitis B virus (HBV) DNA (excluding more than 2500 copies [CPS] / ml or 500 IU / ml) and HCV RNA detection (excluding exceeding the detection limit of the assay) can only be included in the trial after the active hepatitis B or hepatitis C infection requiring treatment is excluded. Hepatitis B virus carriers, patients with stable hepatitis B after drug treatment (DNA titer should not be higher than 2500 copies [CPS] / ml or 500 IU / ml) and patients with cured hepatitis C can be enrolled; 7. Positive test for HIV; 8. History of organ transplantation; 9. History of alcohol or drug abuse; 10. Any other condition that contraindicates the use of radiation or that may affect the interpretation of the results or render the patient at high risk from treatment complications.

Design outcomes

Primary

MeasureTime frame
incidence of radiation pneumonia;grade of radiation pneumonia;

Secondary

MeasureTime frame
incidence of radiation esophagitis;grade of radiation esophagitis;V5 of lung;V20 of lung;V30 of lung;

Countries

China

Contacts

Public ContactGuanghui Li

Department of Oncology, the Second Affiliated Hospital of Army Medical University

am831103@163.com+86 13996181950

Outcome results

None listed

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