Adjuvant Treatment of Concurrent RT and CAPOX or Capecitabine Alone for Stage II and III Rectal Cancer
NCT ID: NCT00714077
Last Updated: 2016-02-17
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
570 participants
Study Classification
OBSERVATIONAL
Study Start Date
2008-04-30
Study Completion Date
2018-06-30
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.
* 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.
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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.
Conditions
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Rectal Neoplasms
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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adjuvant capecitabine
To compare different adjuvant concurrent chemoradiotherapy regimen (Oxaliplatin with capecitabine vs capecitabine) for patients with II/III rectal cancer
No interventions assigned to this group
adjuvant oxaliplatin and capecitabine
To compare different adjuvant concurrent chemoradiotherapy regimen (Oxaliplatin with capecitabine vs capecitabine) for patients with II/III rectal cancer
No interventions assigned to this group
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
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Zhejiang Cancer Hospital
OTHER
Sponsor Role
collaborator
Cancer Hospital of Guizhou Province
OTHER
Sponsor Role
collaborator
Shandong Cancer Hospital and Institute
OTHER
Sponsor Role
collaborator
Hebei Medical University Fourth Hospital
OTHER
Sponsor Role
collaborator
Peking University Third Hospital
OTHER
Sponsor Role
collaborator
General Hospital of Chinese Armed Police Forces
OTHER
Sponsor Role
collaborator
Beijing Hospital
OTHER_GOV
Sponsor Role
collaborator
Chinese Academy of Medical Sciences
OTHER
Sponsor Role
lead
Responsible Party
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Jing Jin, M.D.
M.D.
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Yexiong Li, M.D.
Role: PRINCIPAL_INVESTIGATOR
CAMS
Jing Jin, M.D.;Ph.D
Role: PRINCIPAL_INVESTIGATOR
CAMS
Locations
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Jing Jin
Beijing, Beijing Municipality, China
Site Status
RECRUITING
Jing Jin
Beijing, Beijing Municipality, China
Site Status
RECRUITING
Countries
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China
Central Contacts
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Facility Contacts
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References
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Reference Type
DERIVED
Other Identifiers
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CAMS_rectal cancer_01
Identifier Type: -
Identifier Source: org_study_id
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