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Clinical Trial Results:
Treatment of patients with locally advanced rectal cancer. TEGAFOX (UFT/leukovorin og Oxaliplatin) before, during and after curatively intended radiotherapy. A Danish phase I/II trial

Summary
EudraCT number
 2004-001347-29
Trial protocol
 DK  
Global end of trial date
07 May 2009

Results information
Results version number
 v1(current)
This version publication date
07 Mar 2021
First version publication date
07 Mar 2021
Other versions

Trial information

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Trial identification
Sponsor protocol code
04.08
Additional study identifiers
ISRCTN number
 -
US NCT number
 -
WHO universal trial number (UTN)
 -
Sponsors
Sponsor organisation name
Odense University Hospital
Sponsor organisation address
J.B. Winsløws Vej 2, entrance 140, basement, Odense C, Denmark, 5000
Public contact
Ida Coordt Elle, Odense University Hospital, +45 29335922, ida.coordt.elle@rsyd.dk
Scientific contact
Per Pfeiffer, Odense University Hospital, +45 26283844, per.pfeiffer@rsyd.dk
Paediatric regulatory details
Is trial part of an agreed paediatric investigation plan (PIP)
No
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
No
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
No
Results analysis stage
Analysis stage
Final
Date of interim/final analysis
07 May 2009
Is this the analysis of the primary completion data?
No
Global end of trial reached?
Yes
Global end of trial date
07 May 2009
Was the trial ended prematurely?
No
General information about the trial
Main objective of the trial
To assess toxicity and feasibility of TEGAFOX followed by radiochemotherapy (UFT + oxaliplatin) in patients with LARC
Protection of trial subjects
Average radiation doses for organs at risk (small intestine and bladder) were calculated and recorded. Heating pads were available during administration of i.v. chemotherapy.
Background therapy
 -
Evidence for comparator
 -
Actual start date of recruitment
02 May 2005
Long term follow-up planned
Yes
Long term follow-up rationale
 Safety, Efficacy
Long term follow-up duration
 5 Years
Independent data monitoring committee (IDMC) involvement?
Yes
Population of trial subjects
Number of subjects enrolled per country
Country: Number of subjects enrolled
Denmark: 18
Worldwide total number of subjects
18
EEA total number of subjects
18
Number of subjects enrolled per age group
In utero
0
Preterm newborn - gestational age
0
Newborns (0-27 days)
0
Infants and toddlers (28 days-23 months)
0
Children (2-11 years)
0
Adolescents (12-17 years)
0
Adults (18-64 years)
10
From 65 to 84 years
8
85 years and over
0

Subject disposition

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Recruitment
Recruitment details
 From May 2005 to March 2009, 18 patients (nine men and nine women) were treated according to this phase I trial.

Pre-assignment
Screening details
 All patients had biopsy-proven non-resectable (primary or recurrent) rectal adenocarcinoma (LARC). Patients were eligible if the tumour was fixed to the pelvic wall or otherwise non-resectable as judged clinically by an experienced colorectal surgeon.

Period 1
Period 1 title
Trial period (overall period)
Is this the baseline period?
 Yes
Allocation method
Non-randomised - controlled
Blinding used
 Not blinded

Arms
Are arms mutually exclusive
Yes

Arm title
 Level 0
Arm description
 Tegafox 1: 130 RCT: 30x6 Tegafox 2: 130
Arm type
 Experimental

Investigational medicinal product name
Oxaliplatin
Investigational medicinal product code
Other name
Pharmaceutical forms
Infusion
Routes of administration
Intravenous use
Dosage and administration details
30mg/m2/week i.v.

Arm title
 Level 1
Arm description
 Tegafox 1: 130 RCT: 40x6 Tegafox 2: 130
Arm type
 Experimental

Investigational medicinal product name
Oxaliplatin
Investigational medicinal product code
Other name
Pharmaceutical forms
Infusion
Routes of administration
Intravenous use
Dosage and administration details
40mg/m2/week i.v.

Arm title
 Level 2
Arm description
 Tegafox 1: 130 RCT: 50x6 Tegafox 2: 130
Arm type
 Experimental

Investigational medicinal product name
Oxaliplatin
Investigational medicinal product code
Other name
Pharmaceutical forms
Infusion
Routes of administration
Intravenous use
Dosage and administration details
50mg/m2/week i.v.

Arm title
 Level 3
Arm description
 Tegafox 1: 130 RCT: 60x5 Tegafox 2: 130
Arm type
 Experimental

Investigational medicinal product name
Oxaliplatin
Investigational medicinal product code
Other name
Pharmaceutical forms
Infusion
Routes of administration
Intravenous use
Dosage and administration details
60mg/m2/week i.v.

Number of subjects in period 1
Level 0 Level 1 Level 2 Level 3
Started
6
6
3
3
Completed
6
6
3
1
Not completed
0
0
0
2
     Adverse event, non-fatal
-
-
-
2

Baseline characteristics

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End points

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End points reporting groups
Reporting group title
Level 0
Reporting group description
 Tegafox 1: 130 RCT: 30x6 Tegafox 2: 130

Reporting group title
Level 1
Reporting group description
 Tegafox 1: 130 RCT: 40x6 Tegafox 2: 130

Reporting group title
Level 2
Reporting group description
 Tegafox 1: 130 RCT: 50x6 Tegafox 2: 130

Reporting group title
Level 3
Reporting group description
 Tegafox 1: 130 RCT: 60x5 Tegafox 2: 130

Primary: Maximal tolerable dose

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End point title
 Maximal tolerable dose [1]
End point description
Toxicity was graded according to NCI Common Toxicity Criteria version 2.0. DLT was reached if grade 3 toxicity was observed. Cohorts of three to six patients were entered at each dose level and each cohort was evaluated for the entire combined treatment course before dose escalation was allowed. If one patient at a given dose level developed DLT, three additional patients were planned to be treated at that dose level. If zero or one out of three/six patients developed DLT the dose was escalated with 10 mg/m 2/week. If two or more patients out of three or six developed DLT the MTD was reached.
End point type
Primary
End point timeframe
6 weeks
Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Maximal tolerable dose cannot be statistically analyzed. Toxicity was graded according to NCI Common Toxicity Criteria version 2.0. DLT was reached if grade 3 toxicity was observed. Cohorts of three to six patients were entered at each dose level and each cohort was evaluated for the entire combined treatment course before dose escalation was allowed. See also publication.
End point values
 Level 0 Level 1 Level 2 Level 3
Number of subjects analysed
6
6
3
3
Units: patients without DLT
5
5
3
1
No statistical analyses for this end point

Adverse events

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Adverse events information
Timeframe for reporting adverse events
One year
Assessment type
 Systematic
Dictionary used for adverse event reporting
Dictionary name
 MedDRA
Dictionary version
23.1
Reporting groups
Reporting group title
Level 0
Reporting group description
 -

Reporting group title
Level 1
Reporting group description
 -

Reporting group title
Level 2
Reporting group description
 -

Reporting group title
Level 3
Reporting group description
 -

Serious adverse events
 Level 0 Level 1 Level 2 Level 3
Total subjects affected by serious adverse events
     subjects affected / exposed
0 / 6 (0.00%)
0 / 6 (0.00%)
0 / 3 (0.00%)
0 / 3 (0.00%)
     number of deaths (all causes)
0
0
0
0
     number of deaths resulting from adverse events
0
0
0
0
Frequency threshold for reporting non-serious adverse events: 5%
Non-serious adverse events
 Level 0 Level 1 Level 2 Level 3
Total subjects affected by non serious adverse events
     subjects affected / exposed
6 / 6 (100.00%)
6 / 6 (100.00%)
3 / 3 (100.00%)
3 / 3 (100.00%)
General disorders and administration site conditions
Fatigue
     subjects affected / exposed
4 / 6 (66.67%)
6 / 6 (100.00%)
3 / 3 (100.00%)
3 / 3 (100.00%)
     occurrences all number
4
6
3
3
Pain
     subjects affected / exposed
4 / 6 (66.67%)
3 / 6 (50.00%)
3 / 3 (100.00%)
2 / 3 (66.67%)
     occurrences all number
4
3
3
2
Gastrointestinal disorders
Nausea/vomiting
     subjects affected / exposed
5 / 6 (83.33%)
4 / 6 (66.67%)
3 / 3 (100.00%)
3 / 3 (100.00%)
     occurrences all number
5
4
3
3
Diarrhea
     subjects affected / exposed
4 / 6 (66.67%)
4 / 6 (66.67%)
3 / 3 (100.00%)
3 / 3 (100.00%)
     occurrences all number
4
4
3
3
Skin and subcutaneous tissue disorders
Skin reaction
     subjects affected / exposed
2 / 6 (33.33%)
1 / 6 (16.67%)
1 / 3 (33.33%)
0 / 3 (0.00%)
     occurrences all number
2
1
1
0

More information

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Substantial protocol amendments (globally)
Were there any global substantial amendments to the protocol? No

Interruptions (globally)
Were there any global interruptions to the trial? No

Limitations and caveats
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
None reported

Online references
http://www.ncbi.nlm.nih.gov/pubmed/22248062

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