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

February 15, 2016 updated by: Jing Jin, M.D., Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Prospective Randomized Phase III Study of Concurrent Capecitabine and Radiotherapy With or Without Oxaliplatin as Adjuvant Treatment for Stage II and III Rectal Cancer

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

570

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Jing Jin
        • Principal Investigator:
          • Jing Jin, M.D.;Ph.D
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Multicenter patients enrollment

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
3-year disease free survival rate
Time Frame: the day of surgery to the date of the event
the day of surgery to the date of the event

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival rate
Time Frame: the day of surgery to the date of death or last follow-up
the day of surgery to the date of death or last follow-up
cumulative incidence of local recurrence
Time Frame: the day of surgery to the date of local recurrence
the day of surgery to the date of local recurrence
cumulative incidence of distant metastasis
Time Frame: the day of surgery to the date of distant metastasis
the day of surgery to the date of distant metastasis
compliance
Time Frame: during adjuvant radiotherapy and chemotherapy
during adjuvant radiotherapy and chemotherapy
safety
Time Frame: the day of randomization to the date of death or last follow-up
the day of randomization to the date of death or last follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborators

Zhejiang Cancer Hospital
General Hospital of Chinese Armed Police Forces
Peking University Third Hospital
Beijing Hospital
Shandong Cancer Hospital and Institute
Hebei Medical University Fourth Hospital
Cancer Hospital of Guizhou Province

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

July 9, 2008

First Submitted That Met QC Criteria

July 10, 2008

First Posted (Estimate)

July 14, 2008

Study Record Updates

Last Update Posted (Estimate)

February 17, 2016

Last Update Submitted That Met QC Criteria

February 15, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAMS_rectal cancer_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rectal Neoplasms

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe