Preoperative Chemoradiotherapy With Raltitrexed for Intermediate or Locally Advanced Rectal Cance… (NCT02992886) | Clinical Trial Compass
CompletedPhase 2
Preoperative Chemoradiotherapy With Raltitrexed for Intermediate or Locally Advanced Rectal Cancer in the Fit Elderly
China68 participantsStarted 2016-09
Plain-language summary
The aim of this multicenter phase II study is to evaluate the response rate, local control, disease-free survival and treatment-related toxicity of preoperative chemoradiation for intermediate or locally advanced rectal cancer in the fit elderly.
Who can participate
Age range71 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* Inclusion Criteria:
* Rectal adenocarcinoma, clinical stage II/III(T3-4 or N+, AJCC 7th), and fulfils the intermediate or locally advanced risk category standard of ESMO recal cancer clinical practice guidelines 2013.
* KPS status no less than 70; Charlson comorbidity no more than 2; Fit status evaluated by CGA.
* Life expectancy more than 6 months.
* Hemoglobin \>= 100g/L, white blood cell \>= 3.5\*10E9/L, neutrophil \>= 1.5\*10E9/L, platelet \>= 100\*10E9/L.
* Creatin normal, Total bilirubin normal, AST and AST normal, AKP normal.
* Do not receive surgery ( except palliative colostomy) or chemotherapy or other anti-cancer treatment.
* No previously pelvic irradiation history.
* Through MDT discussion, the patient is considered to be candidate for preoperative CRT followed by surgery.
* Informed consent signed.
* Exclusion Criteria:
* Other cancer history, except curable non-melanoma skin cancer or cervix in-situ carcinoma.
* Allergy history to analog of quinazoline folate.
* Active infection existed.
* Severe complication, such as acute myocardial infarction in 6 months, uncontrolled diabetes ( Plasma glucose concentrations in any time of a day≥11.1mmol/L), severe cardiac arrhythmia, etc.
* Anticipate other clinical trials in four weeks before enrollment.