Rectal Neoplasms
Conditions
Keywords
rectal cancer, concurrent chemoradiotherapy, adjuvant therapy, phase III study
Brief summary
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
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.
Interventions
None listed
Sponsors
Zhejiang Cancer Hospital
Cancer Hospital of Guizhou Province
Shandong Cancer Hospital and Institute
Hebei Medical University Fourth Hospital
Peking University Third Hospital
General Hospital of Chinese Armed Police Forces
Beijing Hospital
Chinese Academy of Medical Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year disease free survival rate | the day of surgery to the date of the event |
Secondary
| Measure | 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 |
Countries
China
Contacts
Primary ContactJing Jin, M.D.
Backup ContactYexiong Li, M.D.
Outcome results
None listed