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Adjuvant Chemotherapy After Preoperative Chemoradiotherapy to Treat Rectal Cancer

Primary Purpose

Rectal Cancer

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Adjuvant FL
Adjuvant FOLFOX
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring rectal cancer, adjuvant chemotherapy, FOLFOX

Eligibility Criteria

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

Inclusion Criteria:

  1. Histologically confirmed adenocarcinoma of the rectum
  2. Patients who treated with preoperative chemoradiation with fluoropyrimidines followed by curative surgery without microscopic residual tumor.
  3. AJCC/UICC pathologic stages of ypT3-4 or ypN+
  4. Curative surgery not less than 3 and not more than 8 weeks prior to randomization
  5. No prior chemotherapy, radiotherapy and immunotherapy except preoperative chemoradiation for rectal cancer
  6. ECOG PS 0-1
  7. Adequate organ function
  8. Informed Consent

Exclusion Criteria:

  1. Macroscopic or microscopic evidence of remaining tumor
  2. Any histologic feature other than adenocarcinoma or arisen from chronic inflammatory bowel disease
  3. More than 8 weeks after curative surgery

Sites / Locations

  • National Cancer Center
  • Seoul National Unversity Bundang Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Seoul National University Hospital
  • Yeonsei University Hosptial

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Adjuvant FL

Adjuvant FOLFOX

Arm Description

FL (5-FU 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles)

FOLFOX (oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 on D1, 5-FU bolus 400 mg/m2 on D1, 5-FU infusion 2400 mg/m2 for 46 hours q 2 weeks X 8 cycles)

Outcomes

Primary Outcome Measures

disease-free survival

Secondary Outcome Measures

overall survival, pattern of failure,safety, quality of life

Full Information

First Posted
December 11, 2008
Last Updated
January 27, 2019
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00807911
Brief Title
Adjuvant Chemotherapy After Preoperative Chemoradiotherapy to Treat Rectal Cancer
Official Title
Randomized Phase II Study of Adjuvant Chemotherapy With 5-FU/Leucovorin vs. Oxaliplatin/5-FU/Leucovorin After Preoperative Chemoradiotherapy With Fluoropyrimidines Followed by Surgery in Patients With Locally Advanced Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the disease-free survival in patients with locally advanced rectal cancer treated with preoperative chemoradiotherapy with fluoropyrimidines and surgery followed by adjuvant combination chemotherapy with oxaliplatin/5-FU/Leucovorin vs 5-FU/Leucovorin.
Detailed Description
Preoperative chemoradiotherapy with fluoropyrimidines followed by surgery is one of the standard treatments for patients with locally advanced rectal cancer; however, the role of adjuvant chemotherapy is still controversial. The aim of this study is to investigate the efficacy of adjuvant FOLFOX for rectal cancer who underwent fluoropyrimidine based chemoradiotherapy and complete total mesorectal excision.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
rectal cancer, adjuvant chemotherapy, FOLFOX

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adjuvant FL
Arm Type
Active Comparator
Arm Description
FL (5-FU 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles)
Arm Title
Adjuvant FOLFOX
Arm Type
Experimental
Arm Description
FOLFOX (oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 on D1, 5-FU bolus 400 mg/m2 on D1, 5-FU infusion 2400 mg/m2 for 46 hours q 2 weeks X 8 cycles)
Intervention Type
Drug
Intervention Name(s)
Adjuvant FL
Intervention Description
5-Fluorouracil 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles
Intervention Type
Drug
Intervention Name(s)
Adjuvant FOLFOX
Intervention Description
oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 on D1, 5-Fluorouracil bolus 400 mg/m2 on D1, 5-Fluorouracil continuous infusion 2400 mg/m2 for 46 hours q 2 weeks X 8 cycles
Primary Outcome Measure Information:
Title
disease-free survival
Time Frame
3 year
Secondary Outcome Measure Information:
Title
overall survival, pattern of failure,safety, quality of life
Time Frame
3 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed adenocarcinoma of the rectum Patients who treated with preoperative chemoradiation with fluoropyrimidines followed by curative surgery without microscopic residual tumor. AJCC/UICC pathologic stages of ypT3-4 or ypN+ Curative surgery not less than 3 and not more than 8 weeks prior to randomization No prior chemotherapy, radiotherapy and immunotherapy except preoperative chemoradiation for rectal cancer ECOG PS 0-1 Adequate organ function Informed Consent Exclusion Criteria: Macroscopic or microscopic evidence of remaining tumor Any histologic feature other than adenocarcinoma or arisen from chronic inflammatory bowel disease More than 8 weeks after curative surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tae Won Kim, Professor
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center
City
Goyang
Country
Korea, Republic of
Facility Name
Seoul National Unversity Bundang Hospital
City
Seongnam
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Yeonsei University Hosptial
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
31593484
Citation
Hong YS, Kim SY, Lee JS, Nam BH, Kim KP, Kim JE, Park YS, Park JO, Baek JY, Kim TY, Lee KW, Ahn JB, Lim SB, Yu CS, Kim JC, Yun SH, Kim JH, Park JH, Park HC, Jung KH, Kim TW. Oxaliplatin-Based Adjuvant Chemotherapy for Rectal Cancer After Preoperative Chemoradiotherapy (ADORE): Long-Term Results of a Randomized Controlled Trial. J Clin Oncol. 2019 Nov 20;37(33):3111-3123. doi: 10.1200/JCO.19.00016. Epub 2019 Oct 8.
Results Reference
derived
PubMed Identifier
25201358
Citation
Hong YS, Nam BH, Kim KP, Kim JE, Park SJ, Park YS, Park JO, Kim SY, Kim TY, Kim JH, Ahn JB, Lim SB, Yu CS, Kim JC, Yun SH, Kim JH, Park JH, Park HC, Jung KH, Kim TW. Oxaliplatin, fluorouracil, and leucovorin versus fluorouracil and leucovorin as adjuvant chemotherapy for locally advanced rectal cancer after preoperative chemoradiotherapy (ADORE): an open-label, multicentre, phase 2, randomised controlled trial. Lancet Oncol. 2014 Oct;15(11):1245-53. doi: 10.1016/S1470-2045(14)70377-8. Epub 2014 Sep 4.
Results Reference
derived

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Adjuvant Chemotherapy After Preoperative Chemoradiotherapy to Treat Rectal Cancer

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