Clinical Trial Results:
Cetuximab (Erbitux®), capecitabine and radiotherapy in neoadjuvant treatment of patients with locally advanced resectable rectal cancer: A phase II Pilot Study
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Summary
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EudraCT number |
2006-001371-38 |
Trial protocol |
SI |
Global end of trial date |
30 Sep 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
21 Dec 2021
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First version publication date |
21 Dec 2021
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Other versions |
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Summary report(s) |
XERT final report |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
EMR 62202-688
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00689702 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Institute of Oncology
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Sponsor organisation address |
Zaloška cesta 2, Ljubljana, Slovenia, 1000
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Public contact |
Vaneja Velenik, Ljubljana Institute of Oncology, vvelenik@onko-i.si
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Scientific contact |
Vaneja Velenik, Ljubljana Institute of Oncology, vvelenik@onko-i.si
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
30 Dec 2015
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Sep 2013
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The pathological complete response rate.
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Protection of trial subjects |
Patients undergoing the study had extra health insurance.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Feb 2007
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Safety, Efficacy, Scientific research | ||
Long term follow-up duration |
5 Years | ||
Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Slovenia: 43
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Worldwide total number of subjects |
43
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EEA total number of subjects |
43
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
37
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From 65 to 84 years |
6
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85 years and over |
0
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Recruitment
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Recruitment details |
Eligible patients had a histologically verified stage II or III adenocarcinoma of the rectum, (International Union against Cancer [UICC] TNM classification 2002). Other inclusion criteria were; ≥18 years of age at diagnosis; World Health Organization (WHO) performance status ≤2. | ||||||||||||||||||||
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Pre-assignment
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Screening details |
Out of 43 patients, one patient did not receive study treatment due to the detection of metastatic disease during the pretreatment work-up. One patient withdrew consent, and another was excluded due to protocol violation. Other three patients were discontinued from the study. Thus 37 patients received Cetuximab and completed the treatment protocol. | ||||||||||||||||||||
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Period 1
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Period 1 title |
Feb 2007-Sep 2008 (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||||
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Arms
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Arm title
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XERT | ||||||||||||||||||||
Arm description |
Patients with resectable LARC received capecitabine (1250 mg/m2 twice daily, orally) for 2 weeks followed by cetuximab alone (400 mg/m2 for 1 week) and then with CRT (250 mg/m2/week) comprising capecitabine (825 mg/m2 twice daily) and radiotherapy to the small pelvis (45 Gy in 25 1.8-Gy fractions), five days a week for five weeks. Surgery was conducted six weeks following CRT, with post-operative chemotherapy with capecitabine (1250 mg/m2 twice daily for 14 days every 21 days) three weeks later. | ||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||
Investigational medicinal product name |
cetuximab
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for solution for infusion
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Routes of administration |
Infusion
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Dosage and administration details |
Patients with resectable LARC received capecitabine (1250 mg/m2 twice daily, orally) for 2 weeks followed by cetuximab alone (400 mg/m2 for 1 week) and then with CRT (250 mg/m2/week) comprising capecitabine (825 mg/m2 twice daily) and radiotherapy to the small pelvis (45 Gy in 25 1.8-Gy fractions), five days a week for five weeks. Surgery was conducted six weeks following CRT, with post-operative chemotherapy with capecit- abine (1250 mg/m2 twice daily for 14 days every 21 days) three weeks later
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Baseline characteristics reporting groups
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Reporting group title |
Feb 2007-Sep 2008
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
XERT
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Reporting group description |
Patients with resectable LARC received capecitabine (1250 mg/m2 twice daily, orally) for 2 weeks followed by cetuximab alone (400 mg/m2 for 1 week) and then with CRT (250 mg/m2/week) comprising capecitabine (825 mg/m2 twice daily) and radiotherapy to the small pelvis (45 Gy in 25 1.8-Gy fractions), five days a week for five weeks. Surgery was conducted six weeks following CRT, with post-operative chemotherapy with capecitabine (1250 mg/m2 twice daily for 14 days every 21 days) three weeks later. | ||
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End point title |
Complete pathological remission rate [1] | ||||||
End point description |
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End point type |
Primary
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End point timeframe |
6 weeks after the preoperative therapy conclusion
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| 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: Statistical analysis was performed using SPSS programme. The data is available in the Final Study Report. |
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| No statistical analyses for this end point | |||||||
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Adverse events information
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Timeframe for reporting adverse events |
During treatment, patients were evaluated weekly. Clinical examinations and complete blood counts were performed and body weight was measured. Toxic side effects were assessed according to National Cancer Institute Common Toxicity Criteria (NCI-CTC V.3.0)
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
NCI-CTC | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
3.0
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Reporting groups
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Reporting group title |
Eligible subjects
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Reporting group description |
Reporting group includes all eligible patients. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Notes [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: More than one adverse event were present per patient. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/20042310 http://www.ncbi.nlm.nih.gov/pubmed/23077464 |
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