In this phase 2 study, the efficacy of total neoadjuvant therapy in Taiwanese patients with rectal cancer will be investigated. Patients with stage II or III middle/low rectal cancer will be prospective enrolled. The total neoadjuvant therapy with the short-course radiotherapy (5×5 Gy over a maximum of 8 days) followed by chemotherapy with mFOLFOX6 for 9 cycles will be administered. The primary endpoint is the complete response (CR) rate which will take into account the patients with clinical and pathological complete response.
This is a single center, single-arm, open-label, phase II study to investigate the efficacy and toxicities of total neoadjuvant therapy in patients with middle or lower rectal cancer. This study is planned to start after the approval by IRB, enroll patients for 2 years, and follow the clinical outcome for another 5 years. It will be conducted at National Cheng Kung University Hospital. Forty-two subjects will be enrolled. Patients who have newly diagnosed stage II or III, middle or low rectal adenocarcinoma will be recruited to receive the TNT treatment. The TNT includes the short-course radiotherapy (5×5 Gy over a maximum of 8 days)) followed by chemotherapy with the regimen of mFOLFOX6 for total 9 cycles
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Short-course radiotherapy, 5×5 Gy.
Oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, infusinal 5-fluorouracil 2400 mg/m2 every 2 weeks, for 9 cycles
National Cheng Kung University Hospital
Tainan, Taiwan
RECRUITINGComplete response (CR) rate
The percentage of patients who achieve a complete response
Time frame: The response will be assessed at the period of 2 to 4 weeks after the completion of total neoadjuvant chemotherapy
R0 resection rate
The percentage of patients who receive the surgery of total neoadjuvant therapy and achieve R0 resection
Time frame: The R0 resection rate will be assessed at the period of 2 to 4 weeks after completion of the total neoadjuvant chemotherapy
Response rate
The percentage of patients who achieve a complete response or partial response
Time frame: The response will be assessed at the period of 2 to 4 weeks after the completion of total neoadjuvant chemotherapy
Loco-regional failure rate
The percentage of patients who develop local recurrence after surgery
Time frame: The loco-regional failure will be assessed from the date of surgical resection until the first documented local recurrence, up to 84 months
Rate of distant metastasis
The percentage of patients who develop distant metastasis
Time frame: The distant metastasis will be assessed from the date of beginning short-course RT until the first documented distant metastasis, up to 84 months
Safety profiles
The occurrence and severity of adverse events which develop during the treatment of total neoadjuvant therapy
Time frame: The safety profile will be assessed from the beginning of the short-course RT to the end of last cycle of FOLFOX chemotherapy, up to 24 weeks
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