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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Rectal Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

disease-free survival

Outcome Time Frame:

3 year

Safety Issue:

No

Principal Investigator

Tae Won Kim, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center

Authority:

Korea: Food and Drug Administration

Study ID:

AMC-0256

NCT ID:

NCT00807911

Start Date:

November 2008

Completion Date:

August 2015

Related Keywords:

  • Rectal Cancer
  • rectal cancer
  • adjuvant chemotherapy
  • FOLFOX
  • Rectal Neoplasms

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