Randomized Controlled Study on Optimize Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer

Study Overview
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Brief Summary
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Although neoadjuvant chemoradiotherapy has significantly reduced the risk of local recurrence in locally advanced rectal cancer, systemic failure remains a predominant issue probably due to the insufficient control of systemic micro-metastasis in the neoadjuvant treatment. Induction chemotherapy is one of the most studied strategies. However, the efficacy of induction chemotherapy prior to neoadjuvant chemotherapy remains controversial. In our previous study, induction chemotherapy, gap chemotherapy combined with neoadjuvant chemoradiotherapy can improve response rate of rectal cancer patients, but the results have not been confirmed in clinical trial. Whether this new kind of treatment can optimize neoadjuvant therapy for locally advanced rectal cancer or not is still a big problem in clinical practice. This study will focus on how to optimize neoadjuvant chemotherapy.

Official Title
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Randomized Controlled Study on Optimize Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer

Conditions
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Advanced Rectal Cancer

Intervention / Treatment
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* Drug: Induction chemotherapy, Chemoradiotherapy and gap chemotherapy (Capecitabine combine with oxaliplatin)
* Radiation: standard chemoradiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathological confirmed rectal cancer Clinical stage T3-4 or T any N1 No metastasis Distance of tumor is no more than 10cm from anal verge No previous radiotherapy Age ranged from 18 to 70 Eastern Cooperative Oncology Group score system 0-1 Exclusion Criteria: Clinical stage T1-2 N0 Distance metastasis Multiple primary tumor Cachexy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard chemoradiotherapy<br>Standard chemoradiotherapy (Capecitabine 825mg/m2 combined with radiotherapy ) | Radiation: standard chemoradiotherapy<br>* All rectal patients in this group will receive standard radiotherapy and surgical resection.<br>|
| Experimental: induction and gap chemotherapy<br>induction chemotherapy (Capecitabine 2000mg/m2 +oxaliplatine 130mg/m2) + 2 cycles of chemoradiotherapy (Capecitabine 2000mg/m2 +oxaliplatine 100mg/m2 combined with radiotherapy) + gap chemotherapy (Capecitabine 2000mg/m2 + oxaliplatine 130mg/m2) | Drug: Induction chemotherapy, Chemoradiotherapy and gap chemotherapy (Capecitabine combine with oxaliplatin)<br>* All rectal cancer patients in this group will receive induction, gap chemotherapy (capecitabine combined with oxaliplatin) alone with chemoradiotherapy (capecitabine combine with oxaliplatin) before surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival |  | 3 years | 
| Disease free survival |  | 5 years | 
| Respond rate |  | One week after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rectal cancer, neoadjuvant chemoradiotherapy, optimization