Prospective Randomized Phase III Study of Concurrent Capecitabine and Radiotherapy With or Without Oxaliplatin as Adjuvant Treatment for Stage II and III Rectal Cancer
18 Years
75 Years
Both
Rectal Neoplasms
Trial Information
Prospective Randomized Phase III Study of Concurrent Capecitabine and Radiotherapy With or Without Oxaliplatin as Adjuvant Treatment for Stage II and III Rectal Cancer
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.
Inclusion Criteria:
- 18-75 years old,male or female
- R0 surgery
- Pathologically approved as stage II or stage III
- Enrolled within 3 months from the date of surgery
- Upper border of tumor before surgery was under L5
- KPS>70% or ECOG 0-2
- No prior chemotherapy or radiotherapy in the past 6 months
- 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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
3-year disease free survival rate
Outcome Time Frame:
First day of treatment to the date of any recurrence
Safety Issue:
Yes
Principal Investigator
Yexiong Li, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
CAMS
Authority:
China: Food and Drug Administration
Study ID:
CAMS_rectal cancer_01
NCT ID:
NCT00714077
Start Date:
April 2008
Completion Date:
December 2013
Related Keywords:
- Rectal Neoplasms
- rectal cancer
- concurrent chemoradiotherapy
- adjuvant therapy
- phase III study
- Neoplasms
- Rectal Neoplasms
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