Adjuvant Treatment of Concurrent RT and CAPOX or Capecitabine Alone for Stage II and III Rectal Cancer

Study Overview
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Brief Summary
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The purpose of this study is: To compare the long-term of survival and local/regional control between the two postoperative concurrent chemoradiotherapy regimens: capecitabine vs. oxaliplatin and capecitabine,for stage II and III rectal cancer To compare the toxicity profile between the two different concurrent chemoradiotherapy regimens.

Detailed Description
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Adjuvant 5-FU based concurrent chemoradiotherapy and chemotherapy is the standard care for locally advanced stage II-III rectal cancer, based on several randomized Phase III clinical trials. With this standard treatment, 5-year local failure rate and distant metastasis rate is 10% and around 35%, respectively. Capecitabine, an analog of 5-fluoruracil (5FU), was demonstrated to have similar treatment results compared to 5-FU, but have much lower toxicities. Oxaliplatin based chemotherapy, also showed a better disease-free survival rate compared with 5-FU based-regimen. So far, some Phase I/II studies have shown the safety and preliminary results of either concurrent chemotherapy of capecitabine or oxaliplatin and capecitabine. The long-term results in comparison of capecitabine concurrent chemoradiotherapy with oxaliplatin/capecitabine concurrent chemoradiotherapy need to be further analyzed.

Official Title
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Prospective Randomized Phase III Study of Concurrent Capecitabine and Radiotherapy With or Without Oxaliplatin as Adjuvant Treatment for Stage II and III Rectal Cancer

Conditions
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Rectal Neoplasms

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-75 years old,male or female R0 surgery Pathologically approved as stage II or stage III Enrolled within 6 months from the date of surgery Upper border of tumor before surgery was under L5 KPS>70% or ECOG 0-2 No prior radiotherapy in the past 6 months Received chemotherapy no more than 4 cycles after surgery HGB>100 g/L, WBC≥3.5x109 /L, PLT≥100x109 /L; CR<1.5 x Upper normality，TB<2.5 X Upper normality，AST or ALT<2.5 x Upper normality，AKP<2.5 X Upper normality Signed consent Exclusion Criteria: Other malignancies simultaneously except in situ cervix or nonmelanoma skin cancer Pregnancy or in lactation HGB<100 g/L, WBC<3.5x109 /L, PLT<100x109 /L; CR≥1.5 x Upper normality，TB≥2.5 X Upper normality，AST or ALT≥2.5 x Upper normality，AKP≥2.5 X Upper normality

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| adjuvant capecitabine<br>To compare different adjuvant concurrent chemoradiotherapy regimen (Oxaliplatin with capecitabine vs capecitabine) for patients with II/III rectal cancer | |
| adjuvant oxaliplatin and capecitabine<br>To compare different adjuvant concurrent chemoradiotherapy regimen (Oxaliplatin with capecitabine vs capecitabine) for patients with II/III rectal cancer | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year disease free survival rate |  | the day of surgery to the date of the event | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival rate |  | the day of surgery to the date of death or last follow-up | 
| cumulative incidence of local recurrence |  | the day of surgery to the date of local recurrence | 
| cumulative incidence of distant metastasis |  | the day of surgery to the date of distant metastasis | 
| compliance |  | during adjuvant radiotherapy and chemotherapy | 
| safety |  | the day of randomization to the date of death or last follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rectal cancer, concurrent chemoradiotherapy, adjuvant therapy, phase III study