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

This study is currently recruiting participants.
Verified February 2016 by Jing Jin, M.D., Chinese Academy of Medical Sciences
Sponsor:
ClinicalTrials.gov Identifier:
NCT00714077
First Posted: July 14, 2008
Last Update Posted: February 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
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
Information provided by (Responsible Party):
Jing Jin, M.D., Chinese Academy of Medical Sciences
  Purpose

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 Phase
Rectal Neoplasms Phase 3

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Jing Jin, M.D., Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • 3-year disease free survival rate [ Time Frame: the day of surgery to the date of the event ]

Secondary Outcome Measures:
  • overall survival rate [ Time Frame: 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 ]
  • cumulative incidence of distant metastasis [ Time Frame: the day of surgery to the date of distant metastasis ]
  • compliance [ Time Frame: during adjuvant radiotherapy and chemotherapy ]
  • safety [ Time Frame: the day of randomization to the date of death or last follow-up ]

Estimated Enrollment: 570
Study Start Date: April 2008
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Multicenter patients enrollment
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00714077


Contacts
Contact: Jing Jin, M.D. 861087788280 jingjin1025@163.com
Contact: Yexiong Li, M.D. 861087788860 yexiong12@163.com

Locations
China, Beijing
Jing Jin Recruiting
Beijing, Beijing, China, 100021
Contact: Jing Jin, M.D.    8610-87788280    jingjin1025@163.com   
Contact: Yexiong Li, M.D.    8610-87788860    yexiong12@163.com   
Principal Investigator: Jing Jin, M.D.;Ph.D         
Jing Jin Recruiting
Beijing, Beijing, China, 100021
Contact: Jing Jin, M.D.    8610-87788280    jingjin25@yahoo.com.cn   
Contact: Yexiong Li, M.D.    8610-87788860    yexiong3@yahoo.com.cn   
Principal Investigator: Jing Jin, M.D.;Ph.D         
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
  More Information

Publications:

Responsible Party: Jing Jin, M.D., M.D., Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT00714077     History of Changes
Other Study ID Numbers: CAMS_rectal cancer_01
First Submitted: July 9, 2008
First Posted: July 14, 2008
Last Update Posted: February 17, 2016
Last Verified: February 2016

Keywords provided by Jing Jin, M.D., Chinese Academy of Medical Sciences:
rectal cancer
concurrent chemoradiotherapy
adjuvant therapy
phase III study

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents