Adjuvant Chemotherapy After Preoperative Chemoradiotherapy to Treat Rectal Cancer

• ClinicalTrials.gov Identifier: NCT00807911
• Recruitment Status: Unknown
• First Posted: December 12, 2008
• Last Update Posted: January 29, 2019
• Sponsor: Asan Medical Center
• Information provided by (Responsible Party): Tae Won Kim, Asan Medical Center

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.

Condition or disease	Intervention/treatment	Phase
Rectal Cancer	Drug: Adjuvant FL; Drug: Adjuvant FOLFOX	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 320 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: November 2008
• Actual Primary Completion Date: July 2014
• Estimated Study Completion Date: December 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Adjuvant FL; FL (5-FU 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles)	Drug: Adjuvant FL; 5-Fluorouracil 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles
Experimental: Adjuvant FOLFOX; 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)	Drug: Adjuvant FOLFOX; 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

Outcome Measures

Primary Outcome Measures :

1. disease-free survival [ Time Frame: 3 year ]

Secondary Outcome Measures :

1. overall survival, pattern of failure,safety, quality of life [ Time Frame: 3 year ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Korea, Republic of

National Cancer Center

Goyang, Korea, Republic of

Seoul National Unversity Bundang Hospital

Seongnam, Korea, Republic of

Asan Medical Center

Seoul, Korea, Republic of

Samsung Medical Center

Seoul, Korea, Republic of

Seoul National University Hospital

Seoul, Korea, Republic of

Yeonsei University Hosptial

Seoul, Korea, Republic of

Sponsors and Collaborators

Asan Medical Center

Investigators

• Principal Investigator: Tae Won Kim, Professor; Asan Medical Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Tae Won Kim, Professor, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT00807911
• Other Study ID Numbers: AMC-0256
• First Posted: December 12, 2008
• Last Update Posted: January 29, 2019
• Last Verified: January 2019

Keywords provided by Tae Won Kim, Asan Medical Center:

rectal cancer; adjuvant chemotherapy; FOLFOX

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