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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DAE YONG KIM, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01129700
First received: May 13, 2010
Last updated: April 25, 2012
Last verified: April 2012
  Purpose

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 ]
    downstaging(ypT0-2N0M0)rate


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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01129700

Locations
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
ClinicalTrials.gov 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
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on October 19, 2014