Clinical trial NCT00714077: Adjuvant Treatment of Concurrent RT and CAPOX or Capecitabine Alone for Stage II and III Rectal Cancer
Official title: Prospective Randomized Phase III Study of Concurrent Capecitabine and Radiotherapy With or Without Oxaliplatin as Adjuvant Treatment for Stage II and III Rectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rectal Neoplasms
Keywords: rectal cancer
concurrent chemoradiotherapy
adjuvant therapy
phase III study
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: Zhejiang Cancer Hospital
name: Cancer Hospital of Guizhou Province
name: Shandong Cancer Hospital and Institute
name: Hebei Medical University Fourth Hospital
name: Peking University Third Hospital
name: General Hospital of Chinese Armed Police Forces
name: Beijing Hospital
First posted: 2008-07-14
Enrollment: 570
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Multicenter patients enrollment

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.

Eligibility criteria: 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

Primary outcomes:
measure: 3-year disease free survival rate
timeFrame: the day of surgery to the date of the event
Secondary outcomes:
measure: overall survival rate
timeFrame: the day of surgery to the date of death or last follow-up
measure: cumulative incidence of local recurrence
timeFrame: the day of surgery to the date of local recurrence
measure: cumulative incidence of distant metastasis
timeFrame: the day of surgery to the date of distant metastasis
measure: compliance
timeFrame: during adjuvant radiotherapy and chemotherapy
measure: safety
timeFrame: the day of randomization to the date of death or last follow-up
Other outcomes:
Locations:
city: Beijing
country: China
facility: Jing Jin
state: Beijing
city: Beijing
country: China
facility: Jing Jin
state: Beijing
Study officials:
affiliation: CAMS
name: Yexiong Li, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: CAMS
name: Jing Jin, M.D.;Ph.D
role: PRINCIPAL_INVESTIGATOR
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