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

Sponsor
National Cancer Center, Korea (Other)
Overall Status
Completed
CT.gov ID
NCT01129700
Collaborator
(none)
73
1
1
24
3

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Interventional
Actual Enrollment :
73 participants
Allocation:
N/A
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 :
Feb 1, 2010
Actual Primary Completion Date :
Feb 1, 2012
Actual Study Completion Date :
Feb 1, 2012

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. To evaluate the pathologic response [After surgery with pathology data]

    downstaging(ypT0-2N0M0)rate

Secondary Outcome Measures

  1. Tumor regression grade & MR volumetry [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 [preoperative CCRT to 3 months after surgery]

    To evaluate the acute and late toxicities

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Cancer Center Korea Goyang-si Gyeonggi-do Korea, Republic of 410-769

Sponsors and Collaborators

  • National Cancer Center, Korea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
DAE YONG KIM, Principal Investigator, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01129700
Other Study ID Numbers:
  • NCCCTS-10-458
First Posted:
May 25, 2010
Last Update Posted:
Apr 27, 2012
Last Verified:
Apr 1, 2012
Keywords provided by DAE YONG KIM, Principal Investigator, National Cancer Center, Korea
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2012