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

This study is currently recruiting participants.
Verified May 2013 by Chinese Academy of Medical Sciences
Sponsor:
Collaborator:
Zhejiang Cancer Hospital
Information provided by (Responsible Party):
Jing Jin, M.D., Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00714077
First received: July 9, 2008
Last updated: May 28, 2013
Last verified: May 2013
  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 Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • 3-year disease free survival rate [ Time Frame: First day of treatment to the date of any recurrence ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Grade 3 or 4 side effects [ Time Frame: any acute side effects more than grade 3 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: April 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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 3 months from the date of surgery
  • Upper border of tumor before surgery was under L5
  • KPS>70% or ECOG 0-2
  • No prior chemotherapy or radiotherapy in the past 6 months
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00714077

Contacts
Contact: Jing Jin, M.D. 861087788280 jingjin25@yahoo.com.cn
Contact: Yexiong Li, M.D. 861087788860 yexiong3@yahoo.com.cn

Locations
China, Beijing
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
Investigators
Principal Investigator: Yexiong Li, M.D. CAMS
Principal Investigator: Jing Jin, M.D.;Ph.D CAMS
  More Information

Publications:
Cividalli A, Ceciarelli F, Livdi E, et al: Radiosensitization by oxaliplatin in a mouse adenocarcinoma: influence of treatment schedule. Int J Radiat Oncol Biol Phys 52:1092-8, 2002

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
Study First Received: July 9, 2008
Last Updated: May 28, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Chinese Academy of Medical Sciences:
rectal cancer
concurrent chemoradiotherapy
adjuvant therapy
phase III study

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

ClinicalTrials.gov processed this record on April 15, 2014