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

Primary Purpose

Rectal Cancer

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Radiation: short-course preoperative chemoradiotherapy
Sponsored by
National Cancer Center, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring rectal cancer, short-course, chemoradiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Cancer Center Korea

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

short-course CRT-5FU

Arm Description

Outcomes

Primary Outcome Measures

To evaluate the pathologic response
downstaging(ypT0-2N0M0)rate

Secondary Outcome Measures

Tumor regression grade & MR volumetry
To evaluate the tumor regression grade & MR volumetry
Acute/ late toxicities
To evaluate the acute and late toxicities

Full Information

First Posted
May 13, 2010
Last Updated
April 25, 2012
Sponsor
National Cancer Center, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01129700
Brief Title
Short-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Locally Advanced Rectal Cancer
Official Title
Short-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Locally Advanced Rectal Cancer: Phase II Multi-institutional Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
rectal cancer, short-course, chemoradiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
short-course CRT-5FU
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Radiation: short-course preoperative chemoradiotherapy
Intervention Description
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 Measure Information:
Title
To evaluate the pathologic response
Description
downstaging(ypT0-2N0M0)rate
Time Frame
After surgery with pathology data
Secondary Outcome Measure Information:
Title
Tumor regression grade & MR volumetry
Description
To evaluate the 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
Title
Acute/ late toxicities
Description
To evaluate the acute and late toxicities
Time Frame
preoperative CCRT to 3 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
National Cancer Center Korea
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of

12. IPD Sharing Statement

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

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