Short-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Locally Advanced Rectal Cancer

This study has been completed.
Information provided by (Responsible Party):
DAE YONG KIM, National Cancer Center, Korea Identifier:
First received: May 13, 2010
Last updated: April 25, 2012
Last verified: April 2012

Concurrent chemoradiotherapy (CRT)

  • Radiotherapy 25 ㏉/5 fractions (start concomitantly at D1)

    • ↓ ↓ ↓ ↓ ↓

      • Radical surgery 6 weeks after completion of chemoradiotherapy

        • ↑ ↑ ↑ ↑ ↑ D1 - - - - - D5
  • 5-Fluorouracil 400㎎/㎡/day + LV 20㎎/㎡/day IV bolus during the radiotherapy

Condition Intervention Phase
Rectal Cancer
Radiation: Radiation: short-course preoperative chemoradiotherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Short-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Locally Advanced Rectal Cancer: Phase II Multi-institutional Study

Resource links provided by NLM:

Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • To evaluate the pathologic response [ Time Frame: After surgery with pathology data ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor regression grade & MR volumetry [ Time Frame: After surgery with pathology data for TRG, at the pretreatment work-up and 1-4 days befor surgery ] [ Designated as safety issue: No ]
    To evaluate the tumor regression grade & MR volumetry

  • Acute/ late toxicities [ Time Frame: preoperative CCRT to 3 months after surgery ] [ Designated as safety issue: Yes ]
    To evaluate the acute and late toxicities

Enrollment: 73
Study Start Date: February 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: short-course CRT-5FU Radiation: Radiation: short-course preoperative chemoradiotherapy

Drug: 5-Fluorouracil 5-Fluorouracil is administered intravenously at a dose of 400 mg/m2 once daily continuous regimen during RT(5 days).

Radiation: Localization, simulation and immobilization Radiation dose and planning Total dose 25Gy, 5 fractions (5 Gy/day).

Detailed Description:

Radiotherapy using tomotherapy is delivered in 5 Gy daily fractions for a total of 25 Gy in 5 fractions.

A bolus injection of 5-fluorouracil (400 mg/m2/d)and leucovorin (20 mg/m2/d) is delivered concurrently on day 1-5 during radiotherapy.

Total mesorectal excision is performed within 6±2 weeks. The pathological response of downstaing is the study endpoint.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria :

  • Pathologically proven diagnosis of adenocarcinoma of the rectum (located within 8㎝ above the anal verge)
  • Locally advanced and curatively resectable tumor(cT3-4 classification) evaluated with magnetic resonance imaging(MRI) with or without transrectal ultrasonography(TRUS)
  • Age ≥18
  • Performance Status(ECOG) 0-2
  • CBC/differential obtained within 14 days prior to registration on study, with adequate bone marrow function defined as follows: Hemoglobin ≥ 10 g/dl, Absolute neutrophil count(ANC) ≥ 1,500 cells/㎣, Platelets ≥ 100,000cells/㎣
  • Metabolic panel within 14 days prior to registration on study, with adequate liver and renal function defined as follows: AST and ALT ≤ 60 IU/L, bilirubin ≤ 1.5 mg/dl, serum creatinine ≤ 1.5 mg/dl
  • Patient must provide study-specific informed consent prior to study entry

Exclusion Criteria :

  • Any evidence of distant metastases(M1)
  • Prior invasive malignancy (except non-melanomatous skin cancer and uterine cervical cancer in situ) unless disease free to a minimum of 3 years
  • Hereditary rectal cancer; Familial adenomatous polyposis(FAP), Hereditary non-polyposis colorectal cancer(HNPCC), etc.
  • Impending obstruction (except the case with colostomy)
  • Severe, active comorbidity inappropriate to CRT as follows; Acute bacterial or fungal infection, transmural myocardial infarction within the last 6 months, unstable arrhythmia, angina and/or congestive heart failure, unstable arrhythmia
  • Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception
  • Unresected synchronous colon carcinoma
  • Clinically unresectable rectal cancer
  Contacts and Locations
Please refer to this study by its identifier: NCT01129700

Korea, Republic of
National Cancer Center Korea
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Sponsors and Collaborators
National Cancer Center, Korea
  More Information

No publications provided

Responsible Party: DAE YONG KIM, Principal Investigator, National Cancer Center, Korea Identifier: NCT01129700     History of Changes
Other Study ID Numbers: NCCCTS-10-458
Study First Received: May 13, 2010
Last Updated: April 25, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by National Cancer Center, Korea:
rectal cancer, short-course, chemoradiotherapy

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases processed this record on April 15, 2014