Trial Outcomes & Findings for Combination Chemotherapy Before or After Surgery in Treating Patients With Colorectal Cancer With Liver Metastases That Could Be Removed By Surgery (NCT NCT01189227)

NCT ID: NCT01189227

Last Updated: 2013-05-10

Results Overview

Time to recurrence or death

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

9 participants

Primary outcome timeframe

From study entry until the date of recurrence or death or for a maximum of 5 years.

Results posted on

2013-05-10

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1: Postoperative Chemotherapy Patients undergo hepatic resection. Beginning 31-56 days after surgery, patients receive mFOLFOX6 or FOLFIRI chemotherapy IV on day 1 over 3 hours. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats every 2 weeks for 12 cycles.	Arm 2: Perioperative Chemotherapy Patients receive mFOLFOX6 or FOLFIRI chemotherapy IV over 3 hours on day 1. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats for every 2 weeks for 6 cycles. Patients then undergo hepatic resection. Beginning 31-56 days after surgery, patients receive an additional 6 cycles of mFOLFOX6 or FOLFIRI chemotherapy.
Overall Study STARTED	6	3
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	6	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1: Postoperative Chemotherapy Patients undergo hepatic resection. Beginning 31-56 days after surgery, patients receive mFOLFOX6 or FOLFIRI chemotherapy IV on day 1 over 3 hours. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats every 2 weeks for 12 cycles.	Arm 2: Perioperative Chemotherapy Patients receive mFOLFOX6 or FOLFIRI chemotherapy IV over 3 hours on day 1. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats for every 2 weeks for 6 cycles. Patients then undergo hepatic resection. Beginning 31-56 days after surgery, patients receive an additional 6 cycles of mFOLFOX6 or FOLFIRI chemotherapy.
Overall Study Study terminated due to low accrual	6	3

Baseline Characteristics

Combination Chemotherapy Before or After Surgery in Treating Patients With Colorectal Cancer With Liver Metastases That Could Be Removed By Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Postoperative Chemotherapy n=6 Participants Postoperative chemotherapy	Perioperative Chemotherapy n=3 Participants Perioperative chemotherapy	Total n=9 Participants Total of all reporting groups
Age Continuous	64 years STANDARD_DEVIATION 14.9 • n=5 Participants	55 years STANDARD_DEVIATION 13.9 • n=7 Participants	61 years STANDARD_DEVIATION 14.4 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: From study entry until the date of recurrence or death or for a maximum of 5 years.

Time to recurrence or death

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From study entry until the date of recurrence or for a maximum of 6 months.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From study entry until the time of death or for a maximum of 5 years.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Assessed at the time of surgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Assessed within 30 days from the time of surgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From study entry through 3 months after the last treatment dose.

Outcome measures

Outcome data not reported

Adverse Events

Postoperative Chemotherapy

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Perioperative Chemotherapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Postoperative Chemotherapy n=5 participants at risk Postoperative chemotherapy	Perioperative Chemotherapy n=2 participants at risk Perioperative chemotherapy
Respiratory, thoracic and mediastinal disorders Respiratory failure	20.0% 1/5 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/2 Participants at Risk includes any patient who submitted an AE form.

Other adverse events

Additional Information

Director, Division of Regulatory Affairs

NSABP Foundation, Inc.

Phone: 412-330-4600

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Postoperative Chemotherapy n=5 participants at risk Postoperative chemotherapy	Perioperative Chemotherapy n=2 participants at risk Perioperative chemotherapy
Gastrointestinal disorders Abdominal pain	0.00% 0/5 Participants at Risk includes any patient who submitted an AE form.	50.0% 1/2 Participants at Risk includes any patient who submitted an AE form.
Investigations Alkaline phosphatase increased	20.0% 1/5 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/2 Participants at Risk includes any patient who submitted an AE form.
Blood and lymphatic system disorders Anemia	20.0% 1/5 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/2 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Anorexia	20.0% 1/5 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/2 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Dehydration	20.0% 1/5 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/2 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Diarrhea	20.0% 1/5 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/2 Participants at Risk includes any patient who submitted an AE form.
Respiratory, thoracic and mediastinal disorders Dyspnea	20.0% 1/5 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/2 Participants at Risk includes any patient who submitted an AE form.
General disorders Fatigue	20.0% 1/5 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/2 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Hypokalemia	20.0% 1/5 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/2 Participants at Risk includes any patient who submitted an AE form.
Respiratory, thoracic and mediastinal disorders Hypoxia	20.0% 1/5 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/2 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Mucositis oral	20.0% 1/5 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/2 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Nausea	20.0% 1/5 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/2 Participants at Risk includes any patient who submitted an AE form.
Investigations Neutrophil count decreased	20.0% 1/5 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/2 Participants at Risk includes any patient who submitted an AE form.
Nervous system disorders Paresthesia	20.0% 1/5 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/2 Participants at Risk includes any patient who submitted an AE form.
Nervous system disorders Peripheral motor neuropathy	20.0% 1/5 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/2 Participants at Risk includes any patient who submitted an AE form.
Nervous system disorders Peripheral sensory neuropathy	20.0% 1/5 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/2 Participants at Risk includes any patient who submitted an AE form.