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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01186081
• Other study ID #: AMC Rectal Pre Vs Post 2004
• Status: Completed
• Phase: Phase 3
• First received: August 18, 2010
• Last updated: August 20, 2010
• Start date: March 2004
• Est. completion date: August 2009

Study information

• Verified date: August 2010
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: August 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

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)
• 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)

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival		Three year	No
Secondary	Overall survival		Three year	No
Secondary	Local relapse-free survival		Three year	No
Secondary	Sphincter preservation rate		Three year	No
Secondary	Treatment related toxicities		Three year	Yes