Total Neoadjuvant Therapy in Rectal Cancer
ConditionRectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20+
SponsorNational Cheng-Kung University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed diagnosis of adenocarcinoma of the rectum;
Tumors located at mid or low rectum (distal extension less than 10 cm from the anal verge);
Clinical stage II or III (T3/4 and/or N+; no distant metastasis);
No prior chemotherapy, radiotherapy or surgery for rectal cancer;
Disqualifiers
Recurrent rectal cancer;
Patients who have concomitant malignancies, except for adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix. Subjects who have prior malignancies and have been disease-free for more than 5 years can be enrolled;
Patients who have received prior pelvic radiotherapy;
Patients with active infection requiring intravenous antibiotic treatment;
Trial design
Design model
Single group
Treatments tested in this trial
Short-course radiotherapy
RadiationShort-course radiotherapy, 5×5 Gy.
mFOLFOX6
DrugOxaliplatin 85 mg/m2, leucovorin 400 mg/m2, infusinal 5-fluorouracil 2400 mg/m2 every 2 weeks, for 9 cycles
Treatment groups
42 Participants
are divided into 1 treatment groupGroup A: Experimental armExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Complete 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 chemotherapySecondary outcomes
1
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 chemotherapy2
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 chemotherapy3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov