Adjuvant Chemotherapy After Preoperative Chemoradiotherapy to Treat Rectal Cancer

NCT00807911 | Completed Phase 2 Results DMC

• 1 other identifier: AMC-0256
• Study Type: interventional
• Target: 322
• Locations: 1 country
• Sites: 6

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.

Conditions

Rectal Cancer

Keywords

rectal cancer; adjuvant chemotherapy; FOLFOX

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Disease Recurrence

  Disease-free survival will be measured as the time from the date of randomization to the date of disease relapse or death due to any cause. Using Cox-proportional hazard regression, the hazard ratio together with the 95% confidence interval will be reported, in addition to Kaplan-Meier estimates of the survival curves, including medians and rates with 95% confidence intervals. Intent-to-treat population included all randomised patients, and per-protocol population included patients who received at least 1 dose of chemotherapy without any violation of inclusion criteria

  up to 3 years after completion of treatment

• Number of Participants With Disease Recurrence With Pathological Stage III

  Disease-free survival will be measured as the time from the date of randomization to the date of disease relapse or death due to any cause. Using Cox-proportional hazard regression, the hazard ratio together with the 95% confidence interval will be reported, in addition to Kaplan-Meier estimates of the survival curves, including medians and rates with 95% confidence intervals. Intent-to-treat population included all randomised patients, and per-protocol population included patients who received at least 1 dose of chemotherapy without any violation of inclusion criteria.

  up to 3 years after completion of treatment

• Number of Participants With Disease Recurrence With Pathological Stage II

  Disease-free survival will be measured as the time from the date of randomization to the date of disease relapse or death due to any cause. Using Cox-proportional hazard regression, the hazard ratio together with the 95% confidence interval will be reported, in addition to Kaplan-Meier estimates of the survival curves, including medians and rates with 95% confidence intervals. Intent-to-treat population included all randomised patients, and per-protocol population included patients who received at least 1 dose of chemotherapy without any violation of inclusion criteria.

  up to 3 years after completion of treatment

Secondary Outcomes (2)

• Death Rate

  Up to 3 years after completion of treatment.

• Pattern of Recurrence

  the time from the date of randomization to the date of disease relapse, , assessed up to 5 years

Study Arms (2)

Adjuvant FL

ACTIVE COMPARATOR

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

Drug: Adjuvant FL

Adjuvant FOLFOX

EXPERIMENTAL

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

Interventions

Adjuvant FL DRUG

5-Fluorouracil 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles

Also known as: fluorouracil, leucovorin

Adjuvant FL

Adjuvant FOLFOX DRUG

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

Also known as: fluorouracil, oxaliplatin, leucovorin

Adjuvant FOLFOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (6)

National Cancer Center

Goyang, South Korea

Location

Seoul National Unversity Bundang Hospital

Seongnam, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Yeonsei University Hosptial

Seoul, South Korea

Location

Related Publications (2)

• 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.

  PMID: 31593484 DERIVED

• 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.

  PMID: 25201358 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Fluorouracil; Leucovorin; Oxaliplatin

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals

Limitations and Caveats

not specific

Results Point of Contact

• Title: Dr. Tae Won Kim
• Organization: Asan Medical Center

twkimmd@amc.seoul.kr

+82-2-3010-3910

Study Officials

• Tae Won Kim, Professor

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 11, 2008
• First Posted: December 12, 2008
• Study Start: November 1, 2008
• Primary Completion: June 30, 2013
• Study Completion: September 5, 2014
• Last Updated: October 23, 2024
• Results First Posted: October 23, 2024

Record last verified: 2024-10

Locations

KR (6)