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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01129700
Recruitment Status : Completed
First Posted : May 25, 2010
Last Update Posted : April 27, 2012
Information provided by (Responsible Party):
DAE YONG KIM, National Cancer Center, Korea

Brief Summary:

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 or disease Intervention/treatment Phase
Rectal Cancer Radiation: Radiation: short-course preoperative chemoradiotherapy Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Arm Intervention/treatment
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).

Primary Outcome Measures :
  1. To evaluate the pathologic response [ Time Frame: After surgery with pathology data ]

Secondary Outcome Measures :
  1. 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 ]
    To evaluate the tumor regression grade & MR volumetry

  2. Acute/ late toxicities [ Time Frame: preoperative CCRT to 3 months after surgery ]
    To evaluate the acute and late toxicities

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01129700

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

Responsible Party: DAE YONG KIM, Principal Investigator, National Cancer Center, Korea Identifier: NCT01129700     History of Changes
Other Study ID Numbers: NCCCTS-10-458
First Posted: May 25, 2010    Key Record Dates
Last Update Posted: April 27, 2012
Last Verified: April 2012

Keywords provided by DAE YONG KIM, 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