Neoadjuvant Sequential Therapy in Locally Advanced Mid/Low Rectal Cancer

Study Overview
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Brief Summary
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Compared curative effect，safety and compliance between concurrent chemoradiotherapy and chemo-chemoradio-chemo sequential therapy in locally advanced mid/low rectal cancer.

Detailed Description
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The patients were divided into two arms according to the defined conditions (pathology rectal adenocarcinoma；distal distance of tumor from anal verge < 10cm；TNM staging T3-4N0-2；no distant metastasis；Karnofsky score≥70) in this prospective, single center, open, non randomized trail (arm A:concurrent chemoradiotherapy, arm B:sequential therapy). Regimens:Arm A:50Gy,2Gy/day per time, 5 days a week, for 5 weeks. +capecitabine 850mg/m2 bid on the day accept radiotherapy. Rest for 8 weeks. Arm B: XELOX 2 cycles (oxaliplatin 130mg/m2 ivgtt 2-6h day 1, capecitabine 1000 mg/m2 Bid day 1-14, repeat every 3 weeks ) → 50Gy,2Gy/day per time, 5 days a week, for 5 weeks.+capecitabine 850mg/m2 bid on the day accept radiotherapy → XELOX 1 cycle. Rest for 2 weeks. Evaluate pre chemotherapy, pre radiotherapy and pre surgery individually. Surgeries followed TME(total mesorectal excision) and PANP(pelvic autonomic nerve preservation) for patients in both arms. Take pathological evaluation of tumors. Take XELOX therapy till 6-8 cycles(pre and after surgery total). Follow up according the schedule.

Official Title
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Efficacy and Safety of Neoadjuvant Chemo-chemoradio-chemo Sequential Therapy in Locally Advanced Mid/Low Rectal Cancer: a Phase II Trial

Conditions
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Rectal Cancer

Intervention / Treatment
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* Drug: Capecitabine
* Drug: XELOX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathology rectal adenocarcinoma Distal distance of tumor from anal verge < 10cm TNM staging T3-4N0-2(MRI) No distant metastasis Karnofsky score≥70 Female patients need contraception during the test Postmenopausal women for at least 12 months, expect pregnancy possibility Patients did not receive chemotherapy, radiotherapy in any form before No other severe related diseases (such as other tumor, severe cardiac and central nervous system diseases, etc.) Exclusion Criteria: Be treated by radiotherapy, chemotherapy or tumor biological therapy before Received immunosuppressive therapy (including corticosteroids) Participated in other clinical trial(s) in 1 month With malignant tumor of colon Peripheral neuropathy (WHO I level and above) Neurological or psychiatric abnormalities affecting cognition , including central nervous system metastasis Severe allergies or allergic history Severe pulmonary or heart disease Pregnant or lactation or refuse contraception during the test Suffering other malignant tumors in past

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Concurrent chemoradiotherapy<br>Capecitabine neoadjuvant concurrent radiochemotherapy and XELOX adjuvant therapy | Drug: Capecitabine<br>* 50Gy, 2Gy/day per time, 5 days a week, for 5 weeks+capecitabine 850mg/m2 bid on the day accept radiotherapy. Rest for 8 weeks and surgery followed.<br>|
| Experimental: Sequential therapy<br>XELOX/capecitabine/XELOX neoadjuvant chemo-chemoradio-chemo sequential therapy and XELOX adjuvant therapy | Drug: XELOX<br>* XELOX 2 cycles (oxaliplatin 130mg/m2 ivgtt 2-6h day 1,capecitabine 1000 mg/m2 bid day 1-14 repeat every 3 weeks) → 50Gy, 2Gy/day per time, 5 days a week, for 5 weeks+capecitabine 850mg/m2 bid on the day accept radiotherapy → XELOX 1 cycle. Rest for 2 weeks and surgery followed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival |  | 3-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local recurrence rate |  | 3 years | 
| Safety: Number of Participants with Adverse Events |  | 3 years | 
| R0 resection rate |  | 1 year | 
| Pathologic complete response |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rectal Cancer, Concurrent Chemoradiotherapy, Sequential Therapy