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

NCT01186081 | Completed Phase 3

• 1 other identifier: AMC Rectal Pre Vs Post 2004
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Keywords

Rectal cancer; Preoperative CCRT; Postoperative CCRT; Capecitabine

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  Three year

Secondary Outcomes (4)

• Overall survival

  Three year

• Local relapse-free survival

  Three year

• Sphincter preservation rate

  Three year

• Treatment related toxicities

  Three year

Study Arms (2)

Preoperative chemoradiotherapy

EXPERIMENTAL

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

Radiation: Preoperative chemoradiotherapy

Postoperative chemoradiotherapy

ACTIVE COMPARATOR

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

Radiation: Postoperative chemoradiotherapy

Interventions

Preoperative chemoradiotherapy 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)

Also known as: Preoperative CCRT

Preoperative chemoradiotherapy

Postoperative chemoradiotherapy 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)

Also known as: Postoperative CCRT

Postoperative chemoradiotherapy

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Jong Hoon Kim, M.D., Ph.D.

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 18, 2010
• First Posted: August 23, 2010
• Study Start: March 1, 2004
• Primary Completion: April 1, 2009
• Study Completion: August 1, 2009
• Last Updated: August 23, 2010

Record last verified: 2010-08

Locations

KR (1)