Radiation proctitis
Conditions
Interventions
Group A:GM-CSF
Group B:Sucralfate
Sponsors
Fudan University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years and above, gender is not limited; 2. Have a full understanding of this research and voluntarily sign the informed consent form, be able to comply with the protocol during the research and complete all experimental procedures; 3. Routine pelvic radiotherapy (single 1.8-2.0Gy, once a day, 5 days a week, total radiotherapy 25-30 times); 4. Eastern Cooperative Oncology Group (ECOG) 0-1 points, the expected survival time is more than 6 months; 5. Assessed by the attending physician and investigator, the function of important organs can bear the risk of treatment, and the baseline blood routine and biochemical indicators meet the following standards: hemoglobin >= 90g/L; absolute neutrophil count (ANC) >=1.5 x 10^9/L; absolute white blood cell count (WBC) >= 3.0 x 10^9/L; Platelet (PLT) >= 100 x 10^9/L; alanine aminotransferase (ALT), aspartate aminotransferase (AST) <= 2.5 times the upper limit of normal (ULN) (if liver metastasis, ALT and AST <= 5 times ULN); serum total bilirubin (TBIL) <= 1.5 times ULN; serum creatinine (SCr) <= 1.5 times ULN; international normalized ratio (INR) <= 2 times ULN, or activated partial thromboplastin time (APPT) <= 1.5 times ULN (except in patients receiving anticoagulant therapy).
Exclusion criteria
Exclusion criteria: 1. Patients with serious concomitant diseases, including uncontrolled and stable medical diseases after treatment, or neurological or psychiatric history (such as dementia or epilepsy), etc., should not receive radiotherapy; 2. The site requiring treatment has received radiotherapy; 3. Malignant pleural effusion or malignant ascites, or accompanied by intestinal obstruction; 4. Pregnant or breastfeeding patients; 5. Patients who are expected to undergo major surgery during the study period; 6. Participated in clinical trials of other drugs within 4 weeks before enrollment; 7. History of alcohol, drug or drug abuse in the past 1 year; 8. Patients deemed by the investigator to be unsuitable to participate in the trial for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiation proctitis; | — |
Countries
China
Contacts
Public ContactZhang Hui
Fudan University Cancer Hospital
Outcome results
None listed