Anal canal cancer
Conditions
Interventions
Case series:Chemotherapy combined with radiotherapy
Sponsors
The Sixth Affiliated Hospital of SUN YAT-SEN University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Untreated patients with anal cancer meet the following criteria at the time of inclusion: (1) prior to the implementation of procedures related to the study protocol but not routine care, the informed consent form with the subject's signature and signature date must be obtained according to the regulations and institutional guidelines; (2) Aged 18-75 years old; (3) pathologically diagnosed patients with anal squamous cell carcinoma; (4) evaluation of pelvic magnetic resonance (detected within 42 days before the start of treatment); (5) peripheral blood analysis and liver and kidney functions are within the following permitted limits (tested within 14 days before the start of treatment): 1) WBC =3.0×10^9/L or neutrophil (ANC) =1.5×10^9/L; 2) hemoglobin (HGB) =80 g/L; 3) platelet (PLT) =100×10^9/L; 4) liver transaminase (AST/ALT) < 3.0 times of the normal range; 5) total bilirubin (TBIL) < 1.5 times of the normal range; 6) creatinine (CREAT) < 1.5 times of the normal range; (6) score of ECOG physical condition is 0-2 (appendix 1); (7) no history of other malignant tumors, except for the cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.
Exclusion criteria
Exclusion criteria: (1) patients with a history of severe drug allergy (including allergy to the taxanes, platinum-based chemotherapy and 5-HT3 receptor antagonists); (2) patients who have previously received chemotherapy, radiotherapy or complete surgical resection for anal squamous cell carcinoma; (3) whole-body CT, MR or PET-CT (including at least chest, whole abdomen and pelvic) confirmed distant metastasis (M1); (4) previous or concurrent existence of other active malignant tumors (except for malignant tumors that have received curative treatment and have not developed for more than 3 years or carcinoma in situ that can be cured by adequate treatment); (5) received major surgery or severe trauma, such as laparotomy, thoracotomy, laparoscopic resection of internal organs, etc., within the previous 4 weeks (the incisions should be completely healed before randomized grouping); (6) active coronary artery disease, severe/unstable angina or newly diagnosed angina or myocardial infarction within 12 months prior to the study; (7) previous events of thrombosis or embolism within 6 months, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism, and deep vein thrombosis; (8) congestive heart failure, grade II or above, New York heart association (NYHA); (9) CTCAE level 2 or above toxicity (except for anemia, hair loss and skin pigmentation) caused by any previous treatment that has not eliminated; (10) received any research drugs in the past; (11) pregnant or lactating women; (12) any medical condition that is unstable or may affect patient safety and study compliance; (13) the investigator determined that the patients are not suitable to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Free Suvival;Overall Survival;Relapse Free Suvival; | — |
Countries
China
Contacts
Public ContactXiangbo Wan, Shuai Liu
Department of Radiotherapy, The Sixth Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed