Last updated on February 2018

RP II Study of SOX vs mFOLFOX6 in Patients With Resectable Rectal Cancer (KSCC1301).

Brief description of study

To evaluate the efficacy and safety of SOX or mFOLFOX6 as neoadjuvant chemotherapy in patients with resectable rectal cancer, and to identify the more promising regimen.

Detailed Study Description

  1. Patient registration procedure

If it is confirmed that the subject meets the inclusion criteria and correspondent none of the exclusion criteria, the subject is registered by using CReS Kyushu registration/allocation system (CK-RAS). The registration with CK-RAS is available for 24hr (URL: and needs for individual ID and password.

2. Quality management

  1. Monitoring
     A central monitoring or in-site monitoring are carried out based on the data from case
     report form (CRF) collecting at data coordinating center. In principle, an on-site
     monitoring is not carried out, but it may be carried out when the on-site monitoring is
     determined to need by Kyushu Study group of Clinical Cancer (KSCC) steering committee
     from the results of the central monitoring so on.

2. Data Monitoring Committee

A Data Monitoring Committee (DMC) has been established.

3. Data entry

     All data will be entered by the double entry method. Referential data rules, valid
     values, range checks, and consistency checks against data already stored in the database
     will be supported. Checks will be applied at the time of data entry into a specific
     field. Additional errors will be detected by programs designed to detect missing data or
     specific errors in the data. The investigator who receives the inquiry will respond by
     checking the original forms for inconsistency, checking other sources to determine the
     correction, modifying the original paper form entering a response to the query.

4. Regular monitoring report

     A regular monitoring report generated by data coordinating center is submitted to KSCC
     Steering Committee, principal investigator, the DMC etc and it is reviewed according to
     "KSCC regulation on the monitoring". The information on the status of site EC approval
     and the achievement of enrollment: number of enrollment- total/per periodical, total/per
     site, is reported monthly using e-mail.

     -  Contents of monitoring report

      1. Study abstract: schema/purpose/subject/endpoint/definition of
       treatment/anticipated enrollment number/progress of the study

      2. Enrollment status: per participating site/total

      3. Monitoring activity: contents of activity/CRF collection per site/uncollected
       CRF, inquiry

      4. Review of the eligible treatment casethe case of ineligible possibility/the
       case determined as ineligible/number of eligible case/the case determined as
       non-treatment/total number of treatment case

      5. Review of a target population for analysis: the number of cases targeted for
       efficacy analysis/safety analysis

      6. Patient background

      7. Treatment time-course: summary of on-treatment and discontinuation/summary of
       reason for discontinuation/list of reason for discontinuation

      8. Protocol violation/deviation

      9. Safety evaluation: serious adverse reaction, event/the case which was notified
       to the study group among the adverse reactions, events with an ordinary
       report/general adverse events

       10. Others

5. Audit

A site audit is carried out by the audit members of KSCC Coordinating Center, data coordinating center, medical staff of other site under the approval of the site director according to "KSCC regulation for site audit". The results of the audit are reported to the site director, KSCC Steering Committee, principal investigator etc. (if required, to DMC).

Clinical Study Identifier: NCT02280070

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