EFS, pCR Rate
Conditions
Keywords
TAS-102, Oxaliplatin, local advanced rectal cancer, concurrent chemoradiotherapy
Brief summary
5-Fluorouracil (5-FU) based chemoradiotherapy is regarded a standard perioperative treatment in locally advanced rectal cancer, but the effective rate still low. We investigate oral TAS-102 plus oxaliplatin concurrent radiotherapy for stage II or III local advanced rectal cancer.
Interventions
DRUGTAS-102 in combination with oxaliplatin
Induction : TAS102 35mg/m2, twice a day for 5 days, on 1st, 3rd, 5th week; Oxliplatin 85mg/m2 on 1st and 2nd week; Rectal radiotherapy 50GY/25f in 5 weeks. 2 weeks no treatment. Consolidation: TAS102 35mg/m2, twice a day for 5 days, every 2 weeks, Oxliplatin 85 mg/m2, every 2 weeks a cycle, for total 3 cycles. 4 weeks no treatment. Surgery Adjuvant chemotherapy: TAS102 35mg/m2, twice a day for 5 days, every 2 weeks, Oxliplatin 85 mg/m2, every 2 weeks a cycle, for total 16 cycles.
Sponsors
Qingdao Central Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Eligible patients are 18 years or older and have histologically confirmed adenocarcinoma of the rectum (defined as the distal border of the tumour less than 16 cm from the anal verge measured by rigid rectoscopy) with no evidence of distant metastases (identified by abdominal ultrasound or CT scan and chest radiography). * Patients in the adjuvant cohort have undergone R0-resection by total mesorectal excision (TME) of a pT3-4 N any or T any N positive non-metastatic rectal cancer. * Patients treated in the neoadjuvant cohort need to have a clinical T3-4 N any or T any N positive tumour staged by endoscopic ultrasound, provided the lower border of the tumour is located 0 - 16 cm from the anal verge measured by rigid rectoscopy and the primary tumour is deemed resectable by TME surgery on the basis of clinical assessment. Other eligibility criteria comprise: WHO status of zero or one; adequate liver, renal, and bone marrow function defined as follows: leucocyte count \> 3,500/µl, thrombocyte count \> 100,000/µl, hemoglobin \> 10.0 g/dl; serum bilirubin \< 2.0 mg/dl, serum creatinine \< 2.0 mg/dl.
Exclusion criteria
* Prior treatment for rectal cancer, prior chemo- or immunotherapy, prior pelvic radiotherapy, or a history of other malignant diseases within the past five years with the exception of successfully treated basal carcinoma of the skin or carcinoma in situ of the uterine cervix. * Participation in another trial, pregnancy, breast-feeding, unwillingness to use effective contraception, or a medical condition or concomitant illness which could potentially interfere with compliance to the protocol are regarded as
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pCR | 24 monthss | pathalogical complete response rate |
| pathologiccal complete response rate | 24 months | tumor cell complete disappear pathologiccally |
Countries
China
Outcome results
None listed