Trial Outcomes & Findings for Capecitabine, Oxaliplatin, Selenomethionine, and Radiation Therapy in Treating Patients Undergoing Surgery For Newly Diagnosed Stage II or III Rectal Adenocarcinoma (NCT NCT00625183)
NCT ID: NCT00625183
Last Updated: 2017-11-17
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
After completion of capecitabine, oxaliplatin, selenomethionine, and radiation, and before surgery. Assessed endoscopically.
Results posted on
2017-11-17
Participant Flow
Participant milestones
| Measure |
Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther
Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther
Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
|
|---|---|
|
Overall Study
Disease Progression
|
1
|
Baseline Characteristics
Capecitabine, Oxaliplatin, Selenomethionine, and Radiation Therapy in Treating Patients Undergoing Surgery For Newly Diagnosed Stage II or III Rectal Adenocarcinoma
Baseline characteristics by cohort
| Measure |
Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther
n=5 Participants
Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
|
|---|---|
|
Age, Continuous
|
56.48 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After completion of capecitabine, oxaliplatin, selenomethionine, and radiation, and before surgery. Assessed endoscopically.Population: Due to the study's early termination, as a result of low accrual, target accrual was not reached and no data was not collected for this assessment.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: After completion of capecitabine, oxaliplatin, selenomethionine, and radiation, and before surgery. Assessed endoscopically.Population: Due to the study's early termination, as a result of low accrual, target accrual was not reached and no data was collected for this assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Adverse events were queried for and collected every cycle for the duration of treatment.Population: All treated and eligible patients
Number of participants with any adverse event as assessed by NCI CTCAE version 3.0.
Outcome measures
| Measure |
Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy
n=5 Participants
Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
|
|---|---|
|
Safety and Tolerability as Assessed by NCI CTCAE Version 3.0
|
5 Participants
|
SECONDARY outcome
Timeframe: During treatment with capecitabine, oxaliplatin, selenomethionine.Population: Due to the study's early termination, as a result of low accrual, target accrual was not reached and no data was collected for this assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: For up to 5 years following surgery.Population: Due to the study's early termination, as a result of low accrual, target accrual was not reached and no data was collected for this assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: For up to 5 years following surgery.Population: Due to the study's early termination, as a result of low accrual, target accrual was not reached and no data was not collected for this assessment.
Outcome measures
Outcome data not reported
Adverse Events
Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther
n=5 participants at risk
Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
|
|---|---|
|
Gastrointestinal disorders
Intestinal obstruction
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
Abscess intestinal
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
20.0%
1/5 • Number of events 1
|
Other adverse events
| Measure |
Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther
n=5 participants at risk
Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
40.0%
2/5 • Number of events 6
|
|
Blood and lymphatic system disorders
Leukopenia
|
40.0%
2/5 • Number of events 2
|
|
Blood and lymphatic system disorders
Lymphopenia
|
100.0%
5/5 • Number of events 15
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
40.0%
2/5 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
60.0%
3/5 • Number of events 7
|
|
Gastrointestinal disorders
Dyspepsia
|
40.0%
2/5 • Number of events 2
|
|
Gastrointestinal disorders
Haemorrhoids
|
60.0%
3/5 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
40.0%
2/5 • Number of events 2
|
|
Gastrointestinal disorders
Proctalgia
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Number of events 1
|
|
General disorders
Chills
|
20.0%
1/5 • Number of events 1
|
|
General disorders
Fatigue
|
40.0%
2/5 • Number of events 2
|
|
General disorders
Pain
|
80.0%
4/5 • Number of events 6
|
|
Immune system disorders
Hypersensitivity
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
Cystitis
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
20.0%
1/5 • Number of events 1
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
80.0%
4/5 • Number of events 4
|
|
Investigations
Aspartate aminotransferase increased
|
40.0%
2/5 • Number of events 2
|
|
Investigations
Haemoglobin decreased
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
40.0%
2/5 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
40.0%
2/5 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
80.0%
4/5 • Number of events 7
|
|
Nervous system disorders
Dysgeusia
|
40.0%
2/5 • Number of events 2
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
80.0%
4/5 • Number of events 4
|
|
Renal and urinary disorders
Bladder spasm
|
20.0%
1/5 • Number of events 1
|
|
Renal and urinary disorders
Dysuria
|
20.0%
1/5 • Number of events 1
|
|
Renal and urinary disorders
Micturition urgency
|
20.0%
1/5 • Number of events 1
|
|
Renal and urinary disorders
Urinary incontinence
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin odour abnormal
|
20.0%
1/5 • Number of events 1
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place