Clinical trial NCT00807911: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rectal Cancer
Keywords: rectal cancer
adjuvant chemotherapy
FOLFOX
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2008-12-12
Enrollment: 322
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Disease Recurrence
timeFrame: up to 3 years after completion of treatment
measure: Number of Participants With Disease Recurrence With Pathological Stage III
timeFrame: up to 3 years after completion of treatment
measure: Number of Participants With Disease Recurrence With Pathological Stage II
timeFrame: up to 3 years after completion of treatment
Secondary outcomes:
measure: Death Rate
timeFrame: Up to 3 years after completion of treatment.
measure: Pattern of Recurrence
timeFrame: the time from the date of randomization to the date of disease relapse, , assessed up to 5 years
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
city: Seongnam
country: Korea, Republic of
facility: Seoul National Unversity Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yeonsei University Hosptial
Study officials:
affiliation: Asan Medical Center
name: Tae Won Kim, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.