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

Sponsor
Chinese Academy of Medical Sciences (Other)
Overall Status
Unknown status
CT.gov ID
NCT00714077
Collaborator
Zhejiang Cancer Hospital (Other), Cancer Hospital of Guizhou Province (Other), Shandong Cancer Hospital and Institute (Other), Hebei Medical University Fourth Hospital (Other), Peking University Third Hospital (Other), General Hospital of Chinese Armed Police Forces (Other), Beijing Hospital (Other)
570
Enrollment
2
Locations
122
Duration (Months)
285
Patients Per Site
2.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    570 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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 Start Date :
    Apr 1, 2008
    Anticipated Primary Completion Date :
    Jan 1, 2018
    Anticipated Study Completion Date :
    Jun 1, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    adjuvant capecitabine

    To compare different adjuvant concurrent chemoradiotherapy regimen (Oxaliplatin with capecitabine vs capecitabine) for patients with II/III rectal cancer
    adjuvant oxaliplatin and capecitabine

    To compare different adjuvant concurrent chemoradiotherapy regimen (Oxaliplatin with capecitabine vs capecitabine) for patients with II/III rectal cancer

    Outcome Measures

    Primary Outcome Measures

    1. 3-year disease free survival rate [the day of surgery to the date of the event]

    Secondary Outcome Measures

    1. overall survival rate [the day of surgery to the date of death or last follow-up]

    2. cumulative incidence of local recurrence [the day of surgery to the date of local recurrence]

    3. cumulative incidence of distant metastasis [the day of surgery to the date of distant metastasis]

    4. compliance [during adjuvant radiotherapy and chemotherapy]

    5. safety [the day of randomization to the date of death or last follow-up]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jing Jin Beijing Beijing China 100021
    2 Jing Jin Beijing Beijing China 100021

    Sponsors and Collaborators

    • Chinese Academy of Medical Sciences
    • 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

    Investigators

    • Principal Investigator: Yexiong Li, M.D., CAMS
    • Principal Investigator: Jing Jin, M.D.;Ph.D, CAMS

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jing Jin, M.D., M.D., Chinese Academy of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT00714077
    Other Study ID Numbers:
    • CAMS_rectal cancer_01
    First Posted:
    Jul 14, 2008
    Last Update Posted:
    Feb 17, 2016
    Last Verified:
    Feb 1, 2016
    Keywords provided by Jing Jin, M.D., M.D., Chinese Academy of Medical Sciences
    rectal cancer
    concurrent chemoradiotherapy
    adjuvant therapy
    phase III study
    Additional relevant MeSH terms:
    Rectal Neoplasms

    Study Results

    No Results Posted as of Feb 17, 2016