Comparison of Preoperative and Postoperative Radiotherapy and Capecitabine in Locally Advanced Rectal Cancer

This study has been completed.
Sponsor:
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01186081
First received: August 18, 2010
Last updated: August 20, 2010
Last verified: August 2010
  Purpose

Based on the potential advantaged of preoperative chemoradiotherapy and oral fluoropyrimidine, the investigators planned a prospective randomized phase III trial which compares preoperative chemoradiotherapy and postoperative chemoradiotherapy with conventional radiation schedule and oral fluoropyrimidine to establish new standard neo-adjuvant therapy regimen in locally advanced rectal cancer.


Condition Intervention Phase
Rectal Cancer
Radiation: Preoperative chemoradiotherapy
Radiation: Postoperative chemoradiotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Preoperative and Postoperative Radiotherapy and Capecitabine in Locally Advanced Rectal Cancer

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: Three year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Three year ] [ Designated as safety issue: No ]
  • Local relapse-free survival [ Time Frame: Three year ] [ Designated as safety issue: No ]
  • Sphincter preservation rate [ Time Frame: Three year ] [ Designated as safety issue: No ]
  • Treatment related toxicities [ Time Frame: Three year ] [ Designated as safety issue: Yes ]

Enrollment: 240
Study Start Date: March 2004
Study Completion Date: August 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Preoperative chemoradiotherapy
Preoperative chemoradiotherapy with conventional radiation schedule and oral fluoropyrimidine (capecitabine)
Radiation: Preoperative chemoradiotherapy
Preoperative chemoradiation with conventional radiotherapy (46 Gy in 23 fractions to the whole pelvis followed by a boost dose of 4 Gy in 2 fractions) and oral fluoropyrimidine (capecitabine 825 mg/m2 twice per day without weekend breaks during whole radiotherapy period)
Other Name: Preoperative CCRT
Active Comparator: Postoperative chemoradiotherapy
Postoperative chemoradiotherapy with conventional radiation schedule and oral fluoropyrimidine (capecitabine)
Radiation: Postoperative chemoradiotherapy
Postoperative radiotherapy with conventional radiation schedule (50 Gy in 25 fractions to the whole pelvis) and oral fluoropyrimidine (capecitabine 825 mg/m2 twice per day without weekend breaks during whole radiotherapy period)
Other Name: Postoperative CCRT

Detailed Description:

Although there have been no confirmative data which favored preoperative chemoradiotherapy, preoperative chemoradiation have many theoretical advantage compared with postoperative one. Preoperative radiotherapy with intensive short course regimen showed significant improvement in local control even with TME, but there has been no large prospective randomized trial which proved the efficacy of preoperative chemoradiotherapy compared with the standard postoperative chemoradiotherapy. Although the final result of the German Trial may give the answer for this question, there has been no randomized controlled trial which investigated the efficacy of preoperative chemoradiotherapy using oral fluoropyrimidine which have many theoretical and clinical advantages mentioned above; the German Trial used 5-day continuous infusion of 5-FU. The investigators think that preoperative chemoradiotherapy with oral capecitabine could be new standard regimen in locally advanced rectal cancer, but this regimen must be compared with the standard postoperative chemoradiotherapy through well designed prospective randomized trial. Based on the potential advantaged of preoperative chemoradiotherapy and oral fluoropyrimidine, the investigators planned prospective randomized phase III trial which compares preoperative chemoradiotherapy and postoperative chemoradiotherapy with conventional radiation schedule and oral fluoropyrimidine to establish new standard neo-adjuvant therapy regimen in locally advanced rectal cancer.

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed rectal adenocarcinoma
  • Tumor located below 10 cm from the anal verge
  • Clinical stage T3 or potentially resectable T4, or N+ on endorectal ultrasonography (EUS) and computed tomography (CT)
  • Patients must be > 18 years and < 76 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Adequate bone marrow reserve
  • Adequate renal function
  • Adequate liver function
  • Signed informed consent prior to randomization

Exclusion Criteria:

  • Evidence of distant metastasis
  • Previous history of chemotherapy or radiotherapy
  • History of malignancy during recent 5 years other than skin cancer
  • Pregnant or lactating woman
  • Familial history of colorectal cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01186081

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Jong Hoon Kim, M.D., Ph.D. Asan Medical Center
  More Information

No publications provided

Responsible Party: Jong Hoon Kim / Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01186081     History of Changes
Other Study ID Numbers: AMC Rectal Pre Vs Post 2004
Study First Received: August 18, 2010
Last Updated: August 20, 2010
Health Authority: Korea: Institutional Review Board

Keywords provided by Asan Medical Center:
Rectal cancer
Preoperative CCRT
Postoperative CCRT
Capecitabine

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
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014