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

NCT ID: NCT01186081

Last Updated: 2010-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31
• Study Completion Date: 2009-08-31

Brief Summary

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.

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.

Conditions

Rectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Preoperative chemoradiotherapy

Preoperative chemoradiotherapy with conventional radiation schedule and oral fluoropyrimidine (capecitabine)

Group Type: EXPERIMENTAL

Preoperative chemoradiotherapy

Intervention Type: RADIATION

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)

Postoperative chemoradiotherapy

Postoperative chemoradiotherapy with conventional radiation schedule and oral fluoropyrimidine (capecitabine)

Group Type: ACTIVE_COMPARATOR

Postoperative chemoradiotherapy

Intervention Type: RADIATION

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)

Interventions

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)

Intervention Type: 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)

Intervention Type: RADIATION

Other Intervention Names

Preoperative CCRT; Postoperative CCRT

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Asan Medical Center

Principal Investigators

Jong Hoon Kim, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

AMC Rectal Pre Vs Post 2004

Identifier Type: -

Identifier Source: org_study_id