Trial Outcomes & Findings for Perioperative Chemotherapy in Treating Patients With Colon Cancer That Can Be Surgically Removed (NCT NCT00002525)

Last Updated: 2023-06-28

Results Overview

Overall survival (OS) is defined as time from randomization to death from any cause or last date known alive. Kaplan-Meier method was used to estimate 5-year OS rate

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

859 participants

Primary outcome timeframe

every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization

Results posted on

2023-06-28

Participant Flow

This study was activated on August 20, 1993 and was terminated on May 19, 2000 before reaching its accrual goal due slow accrual. The first accrual was on October 1, 1993. The final accrual for the study was 859 patients.

Participant milestones

Participant milestones
Measure	Perioperative 5-FU Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days. After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m\^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m\^2 IV push on days 1-5 fluorouracil: Perioperative 5-FU: 600 mg/m\^2/d x 7 days continuous IV, beginning within 24 hours of surgery After surgery, 5-FU was given 425 mg/m\^2 IV push on days 1-5 leucovorin calcium: given after surgery at dose of 20mg/m\^2 IV push on days 1-5	No Perioperative 5-FU Patients receive no perioperative fluorouracil. After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m\^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m\^2 IV push on days 1-5 fluorouracil: Perioperative 5-FU: 600 mg/m\^2/d x 7 days continuous IV, beginning within 24 hours of surgery After surgery, 5-FU was given 425 mg/m\^2 IV push on days 1-5 leucovorin calcium: given after surgery at dose of 20mg/m\^2 IV push on days 1-5
Overall Study STARTED	427	428
Overall Study Treated	419	0
Overall Study Dukes' B3 or C Stage	156	158
Overall Study Dukes' B2 Stage	150	139
Overall Study COMPLETED	241	428
Overall Study NOT COMPLETED	186	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Perioperative 5-FU Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days. After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m\^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m\^2 IV push on days 1-5 fluorouracil: Perioperative 5-FU: 600 mg/m\^2/d x 7 days continuous IV, beginning within 24 hours of surgery After surgery, 5-FU was given 425 mg/m\^2 IV push on days 1-5 leucovorin calcium: given after surgery at dose of 20mg/m\^2 IV push on days 1-5	No Perioperative 5-FU Patients receive no perioperative fluorouracil. After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m\^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m\^2 IV push on days 1-5 fluorouracil: Perioperative 5-FU: 600 mg/m\^2/d x 7 days continuous IV, beginning within 24 hours of surgery After surgery, 5-FU was given 425 mg/m\^2 IV push on days 1-5 leucovorin calcium: given after surgery at dose of 20mg/m\^2 IV push on days 1-5
Overall Study Adverse Event	36	0
Overall Study Death	5	0
Overall Study Withdrawal by Subject	11	0
Overall Study Start non-protocol therapy	1	0
Overall Study Other complicating disease	1	0
Overall Study Duke's A, B1, D disease	92	0
Overall Study Error	6	0
Overall Study Other	26	0
Overall Study Never start protocol therapy	8	0

Baseline Characteristics

Perioperative Chemotherapy in Treating Patients With Colon Cancer That Can Be Surgically Removed

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Perioperative 5-FU n=156 Participants Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days. After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m\^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m\^2 IV push on days 1-5 fluorouracil: Perioperative 5-FU: 600 mg/m\^2/d x 7 days continuous IV, beginning within 24 hours of surgery After surgery, 5-FU was given 425 mg/m\^2 IV push on days 1-5 leucovorin calcium: given after surgery at dose of 20mg/m\^2 IV push on days 1-5	No Perioperative 5-FU n=158 Participants Patients receive no perioperative fluorouracil. After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m\^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m\^2 IV push on days 1-5 fluorouracil: Perioperative 5-FU: 600 mg/m\^2/d x 7 days continuous IV, beginning within 24 hours of surgery After surgery, 5-FU was given 425 mg/m\^2 IV push on days 1-5 leucovorin calcium: given after surgery at dose of 20mg/m\^2 IV push on days 1-5	Total n=314 Participants Total of all reporting groups
Age, Continuous	63 Years n=5 Participants	66 Years n=7 Participants	65 Years n=5 Participants
Sex/Gender, Customized Female	57 participants n=5 Participants	61 participants n=7 Participants	118 participants n=5 Participants
Sex/Gender, Customized Male	99 participants n=5 Participants	96 participants n=7 Participants	195 participants n=5 Participants

PRIMARY outcome

Timeframe: every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization

Population: All randomized patients with Dukes' B3 and C disease

Overall survival (OS) is defined as time from randomization to death from any cause or last date known alive. Kaplan-Meier method was used to estimate 5-year OS rate

Outcome measures

Outcome measures
Measure	Perioperative 5-FU n=156 Participants Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days. After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m\^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m\^2 IV push on days 1-5 fluorouracil: Perioperative 5-FU: 600 mg/m\^2/d x 7 days continuous IV, beginning within 24 hours of surgery After surgery, 5-FU was given 425 mg/m\^2 IV push on days 1-5 leucovorin calcium: given after surgery at dose of 20mg/m\^2 IV push on days 1-5	No Perioperative 5-FU n=158 Participants Patients receive no perioperative fluorouracil. After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m\^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m\^2 IV push on days 1-5 fluorouracil: Perioperative 5-FU: 600 mg/m\^2/d x 7 days continuous IV, beginning within 24 hours of surgery After surgery, 5-FU was given 425 mg/m\^2 IV push on days 1-5 leucovorin calcium: given after surgery at dose of 20mg/m\^2 IV push on days 1-5
5-year Overall Survival Rate in Patients With Dukes' B3/C Disease	0.666 proportion of participants Interval 0.585 to 0.735	0.612 proportion of participants Interval 0.53 to 0.683

SECONDARY outcome

Timeframe: every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization

Population: All randomized patients with Dukes' B3 and C disease who had complete disease assessment data

Disease-free survival (DFS) was defined as time from randomization to recurrence, second invasive primary cancer, or deaths, whichever occurred first. Patients who were still alive and had no DFS events were censored at the last disease assessment date known to be free of DFS events. Patients without any follow up data were censored at random assignment. Kaplan-Meier method was used to estimate the 5-year DFS rate.

Outcome measures

Outcome measures
Measure	Perioperative 5-FU n=128 Participants Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days. After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m\^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m\^2 IV push on days 1-5 fluorouracil: Perioperative 5-FU: 600 mg/m\^2/d x 7 days continuous IV, beginning within 24 hours of surgery After surgery, 5-FU was given 425 mg/m\^2 IV push on days 1-5 leucovorin calcium: given after surgery at dose of 20mg/m\^2 IV push on days 1-5	No Perioperative 5-FU n=131 Participants Patients receive no perioperative fluorouracil. After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m\^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m\^2 IV push on days 1-5 fluorouracil: Perioperative 5-FU: 600 mg/m\^2/d x 7 days continuous IV, beginning within 24 hours of surgery After surgery, 5-FU was given 425 mg/m\^2 IV push on days 1-5 leucovorin calcium: given after surgery at dose of 20mg/m\^2 IV push on days 1-5
5-year Disease-free Survival Rate in Patients With Dukes' B3/C Disease	0.582 proportion of participants Interval 0.486 to 0.668	0.543 proportion of participants Interval 0.442 to 0.634

SECONDARY outcome

Timeframe: every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization

Population: All randomized patients with Dukes' B2 disease

Overall survival (OS) is defined as time from randomization to death from any cause or last date known alive. Kaplan-Meier method was used to estimate 5-year OS rate

Outcome measures

Outcome measures
Measure	Perioperative 5-FU n=150 Participants Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days. After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m\^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m\^2 IV push on days 1-5 fluorouracil: Perioperative 5-FU: 600 mg/m\^2/d x 7 days continuous IV, beginning within 24 hours of surgery After surgery, 5-FU was given 425 mg/m\^2 IV push on days 1-5 leucovorin calcium: given after surgery at dose of 20mg/m\^2 IV push on days 1-5	No Perioperative 5-FU n=139 Participants Patients receive no perioperative fluorouracil. After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m\^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m\^2 IV push on days 1-5 fluorouracil: Perioperative 5-FU: 600 mg/m\^2/d x 7 days continuous IV, beginning within 24 hours of surgery After surgery, 5-FU was given 425 mg/m\^2 IV push on days 1-5 leucovorin calcium: given after surgery at dose of 20mg/m\^2 IV push on days 1-5
5-year Overall Survival Rate in Patients With Dukes' B2 Disease	0.851 proportion of participants Interval 0.783 to 0.899	0.780 proportion of participants Interval 0.701 to 0.841

SECONDARY outcome

Timeframe: every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization

Population: All randomized patients with Dukes' B2 disease who had complete disease assessment data

Outcome measures

Outcome measures
Measure	Perioperative 5-FU n=133 Participants Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days. After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m\^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m\^2 IV push on days 1-5 fluorouracil: Perioperative 5-FU: 600 mg/m\^2/d x 7 days continuous IV, beginning within 24 hours of surgery After surgery, 5-FU was given 425 mg/m\^2 IV push on days 1-5 leucovorin calcium: given after surgery at dose of 20mg/m\^2 IV push on days 1-5	No Perioperative 5-FU n=123 Participants Patients receive no perioperative fluorouracil. After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m\^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m\^2 IV push on days 1-5 fluorouracil: Perioperative 5-FU: 600 mg/m\^2/d x 7 days continuous IV, beginning within 24 hours of surgery After surgery, 5-FU was given 425 mg/m\^2 IV push on days 1-5 leucovorin calcium: given after surgery at dose of 20mg/m\^2 IV push on days 1-5
5-year Disease-free Survival Rate in Patients With Dukes' B2 Disease	0.749 proportion of participants Interval 0.66 to 0.818	0.724 proportion of participants Interval 0.626 to 0.801

Adverse Events

Arm I (Perioperative 5-FU)

Serious events: 75 serious events

Other events: 236 other events

Deaths: 0 deaths

Arm II (No Perioperative 5-FU)

Serious events: 4 serious events

Other events: 9 other events

Deaths: 0 deaths

Adjuvant Chemotherapy-- 5-FU+Levamisolem

Serious events: 76 serious events

Other events: 167 other events

Deaths: 0 deaths

Adjuvant Chemotherapy-- 5-FU+Leucovovin

Serious events: 32 serious events

Other events: 58 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Arm I (Perioperative 5-FU) n=418 participants at risk Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days. After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m\^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m\^2 IV push on days 1-5 fluorouracil: Perioperative 5-FU: 600 mg/m\^2/d x 7 days continuous IV, beginning within 24 hours of surgery After surgery, 5-FU was given 425 mg/m\^2 IV push on days 1-5 leucovorin calcium: given after surgery at dose of 20mg/m\^2 IV push on days 1-5	Arm II (No Perioperative 5-FU) n=422 participants at risk Patients receive no perioperative fluorouracil. After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m\^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m\^2 IV push on days 1-5 fluorouracil: Perioperative 5-FU: 600 mg/m\^2/d x 7 days continuous IV, beginning within 24 hours of surgery After surgery, 5-FU was given 425 mg/m\^2 IV push on days 1-5 leucovorin calcium: given after surgery at dose of 20mg/m\^2 IV push on days 1-5	Adjuvant Chemotherapy-- 5-FU+Levamisolem n=171 participants at risk Beginning 21-35 days after surgery, patients with stage IIC or III disease enrolled between September 1997 and May 2000 receive the following adjuvant chemotherapy: Leucovorin: 20 mg/m² IV push days 1-5 5-FU: 425 mg/m² IV push days 1-5, give immediately after Leucovorin A cycle of therapy consisted of 5 consecutive days of chemotherapy. Cycles were repeated at the end of 4 weeks (day 29), 8 weeks (day 57) and then every 4 weeks for a total of 6 cycles. All patients with Dukes' B3/C disease for who adverse vents were collected were included in the analysis.	Adjuvant Chemotherapy-- 5-FU+Leucovovin n=61 participants at risk After surgery, patients with stage IIC or III disease enrolled between August 1993 and August 1997 receive the following adjuvant chemotherapy: Levamisole: 50 mg PO TID Days 1-3 and Days 15-17; 50 mg PO TID x 3 days beginning Day 29, repeat every 14 days for 11 months. 5-FU: 450 mg/m²/day IV bolus for Days 1-5. 450 mg/m² IV bolus once weekly beginning Day 29, repeat weekly for a maximum of 11 months. All patients with Dukes' B3/C disease for who adverse vents were collected were included in the analysis.
Investigations Leukopenia	6.0% 25/418 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	0.47% 2/422 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	45.6% 78/171 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	52.5% 32/61 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.
Investigations Thrombocytopenia	5.7% 24/418 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	0.00% 0/422 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	38.6% 66/171 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	23.0% 14/61 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.
Blood and lymphatic system disorders Anemia	50.0% 209/418 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	1.7% 7/422 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	61.4% 105/171 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	70.5% 43/61 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.
General disorders Fever (No Infection)	10.8% 45/418 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	0.24% 1/422 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	8.8% 15/171 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	11.5% 7/61 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.
Gastrointestinal disorders Nausea/vomiting	27.8% 116/418 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	0.95% 4/422 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	55.0% 94/171 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	44.3% 27/61 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.
Gastrointestinal disorders Vomiting	14.4% 60/418 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	0.71% 3/422 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	26.3% 45/171 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	18.0% 11/61 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.
Gastrointestinal disorders Diarrhea	16.0% 67/418 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	0.71% 3/422 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	43.3% 74/171 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	44.3% 27/61 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.
Gastrointestinal disorders Stomatitis	17.0% 71/418 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	0.24% 1/422 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	34.5% 59/171 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	32.8% 20/61 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.
Skin and subcutaneous tissue disorders Skin	9.3% 39/418 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	0.47% 2/422 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	42.7% 73/171 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	39.3% 24/61 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.
Nervous system disorders Neuro-clinical	5.0% 21/418 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	0.24% 1/422 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	49.1% 84/171 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	29.5% 18/61 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.
Infections and infestations Infection	0.00% 0/418 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	0.00% 0/422 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	19.3% 33/171 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	14.8% 9/61 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.
Nervous system disorders Neuro-motor	1.4% 6/418 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	0.00% 0/422 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	19.3% 33/171 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	4.9% 3/61 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.
Nervous system disorders Neuro-psych	2.2% 9/418 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	0.24% 1/422 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	9.9% 17/171 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.	8.2% 5/61 • Patients on Arm I received perioperative 5-FU, patients on Arm II received no perioperative chemotherapy. AEs, however, were reported for all patients and assessed at the end of treatment and 30 days after the last dose of the therapy. After completion of perioperative 5-FU, patients with Dukes' B3/C disease continued to receive the then standard adjuvant chemotherapy for colon cancer. AEs for the adjuvant chemotherapy (5-FU+ Levamisolem and 5-FU+Leucovovin) in patients with Dukes' B3/C disease were collected separately and reported here as well.

Additional Information

Study statistician

ECOG-ACRIN Statistical Office

Phone: 617-632-3012

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60