Rectal Cancer
Conditions
Interventions
Single:Radiation Therapy + mFOLFOX6 regimen
Sponsors
Radiation Therapy Center, Sichuan Cancer Hospital & Institute,Sichuan Cancer Center,School of Medicine, University of Electronic Science and Technology of China
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. the patient is over 18 years old 2. Patient can remain stationary on the treatment bed for 1-1.5 hours 3. ECOG score 0-1 4. pathological tissue is adenocarcinoma of the rectum 5. locally advanced rectal cancer as cT3 N1-2 and cT4 N0-2 6. normal organ function with the following conditions: white blood cell count = 3.5 ×109/L; platelet count = 100 ×109/L; hemoglobin = 90g/L. total bilirubin level = 1.5 × upper limit of normal (ULN) range; AST and ALT levels = 2.5 × ULN; endogenous creatinine clearance:56-122ml/min; serum creatinine < 1.0 × ULN; serum albumin = 30g/L. 7. able to comply with the protocol for the duration of the study 8. Signed written informed consent Translated with www.DeepL.com/Translator (free version)
Exclusion criteria
Exclusion criteria: 1. the presence of other types of tumors in addition to rectal adenocarcinoma 2. Cannot undergo MRI or treatment for reasons such as claustrophobia or placement of metal devices in the body 3. distant metastases (M1) 4. Pregnant or breastfeeding women 5. previous antineoplastic treatment 6. concurrent treatment with impermissible drugs 7. Known history of positive human immunodeficiency virus testing or known acquired immunodeficiency syndrome 8. clinically significant (i.e., active) cardiovascular disease: cerebrovascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (= New York Heart Association classification class II), or severe arrhythmia requiring pharmacologic treatment 9. individuals with a history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorders whose clinical severity, in the judgment of the investigator, may prevent signing an informed consent form or affect patient compliance with oral medications 10. organ transplantation requiring immunosuppressive therapy 11. severe uncontrolled recurrent infections or other serious uncontrolled co-morbidities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of MRI guided dose adaptive chemoradiation therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Complete Clinical Response (cCR);Number of Participants with Pathological Complete Response (pCR); | — |
Countries
China
Contacts
Public ContactQian Peng
Radiation Therapy Center, Sichuan Cancer Hospital & Institute,Sichuan Cancer Center,School of Medicine, University of Electronic Science and Technology of China
Outcome results
None listed