Rectal CancerPhase 2PrePaRadNCT00973193
Preoperative Panitumumab and Radiotherapy in Rectal Cancer
A Phase 2 study testing panitumumab in people with Rectal Cancer, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 8 sites in Belgium.
Trial summary
The purpose of this study is to investigate the activity of panitumumab in combination with standard preoperative radiotherapy in locally advanced rectal cancer, followed by complete surgery and adjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- panitumumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 8 sitesBelgium
- Study dates
- Sep 2009to Dec 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECOG Performance Status 0-1
- Histologically proven adenocarcinoma of the rectum, T3-T4 and/or N+ M0
- Wild-type KRAS
- No prior pelvic irradiation
- Normal bone marrow, hepatic, renal, cardiac functions
- No secondary malignancy
- No other active, uncontrolled disease
- Signed informed consent
Who cannot join
- KRAS mutation
- Established or suspected metastasis
- Prior pelvic irradiation
- Previous exposure to EGFR-targeting therapies
- Patients under any other investigational agent(s)
- Concurrent systemic immune therapy, chemotherapy, hormone therapy
Show all 10Show fewer
- Drug and/or alcohol abuse
- Grade 3 to 4 allergic reaction to any of the components of the treatment
- History or presence of interstitial lung disease
- Active, uncontrolled cardiovascular disease
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Belgium8 sites
Institute Jules Bordet
Brussels, 1000
Cliniques Universitaires Saint Luc - Université Catholique de Louvain
Brussels, 1200
Centre Hospitalier Notre Dame et Reine Fabiola
Charleroi, 6000
Centre Hospitalier de Jolimont-Lobbes
La Louvière, 7100
UZ Gasthuisberg
Leuven, 3000
Clinique et Maternité Saint Elizabeth
Namur, 5000
Clinique Saint Pierre
Ottignies, 1340
Clinique Universitaire de Mont Godinne
Yvoir, 5530
About this study
Official title: Phase II Study of Preoperative Panitumumab and External Beam Radiotherapy in Patients With Locally Advanced Rectal Cancer
The purpose of this study is to investigate the activity of panitumumab in combination with standard preoperative radiotherapy in locally advanced rectal cancer, followed by complete surgery and adjuvant chemotherapy.
The main hypothesis of the study is that the association of EGFR-targeting agent and radiation therapy could be as effective or even improve the rate of pathological complete tumoral response with fewer toxicities in comparison to the standard of care using chemoradiation therapy.
Read the detailed description
Anti-EGFR monoclonal antibodies have radiosensitizing properties. In particular, cetuximab in combination with curative-intent radiotherapy has been reported to increase median overall survival over radiation therapy alone in locally advanced head and neck carcinoma.
Similar benefit in rectal cancer is expected. However, preliminary studies revealed that the combination of chemoradiation and cetuximab did not seem to improve the pathological tumor response. However, in the past studies, the selection of patients' population was not optimal since KRAS mutational status was not considered during recruitments.
Therefore, new trials to investigate EGFR-targeting therapies in combination with radiotherapy in wild-type KRAS patients are required.
Adjuvant chemotherapy has also shown to decrease the risk of local relapse in patients who did not receive chemotherapy during radiotherapy. In our study, since there will be no chemotherapy given during the preoperative setting, the administration of adjuvant chemotherapy postoperatively is highly recommended.
- Conditions
- Rectal Cancer
- Being tested
- panitumumab
- Keywords
- rectum, colorectal, cancer, adenocarcinoma, anti-EGFR, monoclonal antibodies, neoadjuvant therapy, preoperative radiotherapy
- Medical subject headings
- Rectal Neoplasms, Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
panitumumabDrug
Also called Vectibix
intravenous infusion of panitumumab, 6 mg per kg body weight, once every 14 days for a total of 42 days
| Study group | Role | What they receive |
|---|---|---|
| panitumumab | Experimental | Not described Receives: Drug: panitumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR)
Measured: 11 weeks
Secondary outcomes (1)
Safety, pathologic R0 resection, negative Circumferential Resection Margin, pathologic downstaging, tumor regression grade, quality of mesorectal excision, rate of sphincter-preservation, Disease-Free Survival, local control rate, translational research
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2011
- Study completionDec 2012
Why it stopped: The intermediate analyses did not allowed to continue the clinical study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Pascal H Machiels, MD, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973193
- Sponsor's protocol ID
- UCL-ONCO 09-001
- Other IDs
- Academic study
- Acronym
- PrePaRad
- Status last verified
- Apr 2016
- First submitted
- 7 Sep 2009
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Preoperative Panitumumab and External Beam Radiotherapy in Patients With Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT00973193
- Acronym / sponsor ID
- PrePaRad / UCL-ONCO 09-001
- Conditions
- Rectal Cancer
- Keywords
- rectum, colorectal, cancer, adenocarcinoma, anti-EGFR, monoclonal antibodies, neoadjuvant therapy, preoperative radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The intermediate analyses did not allowed to continue the clinical study.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 9 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the activity of panitumumab in combination with standard preoperative radiotherapy in locally advanced rectal cancer, followed by complete surgery and adjuvant chemotherapy.
The main hypothesis of the study is that the association of EGFR-targeting agent and radiation therapy could be as effective or even improve the rate of pathological complete tumoral response with fewer toxicities in comparison to the standard of care using chemoradiation therapy.
Detailed description
Anti-EGFR monoclonal antibodies have radiosensitizing properties. In particular, cetuximab in combination with curative-intent radiotherapy has been reported to increase median overall survival over radiation therapy alone in locally advanced head and neck carcinoma.
Similar benefit in rectal cancer is expected. However, preliminary studies revealed that the combination of chemoradiation and cetuximab did not seem to improve the pathological tumor response. However, in the past studies, the selection of patients' population was not optimal since KRAS mutational status was not considered during recruitments.
Therefore, new trials to investigate EGFR-targeting therapies in combination with radiotherapy in wild-type KRAS patients are required.
Adjuvant chemotherapy has also shown to decrease the risk of local relapse in patients who did not receive chemotherapy during radiotherapy. In our study, since there will be no chemotherapy given during the preoperative setting, the administration of adjuvant chemotherapy postoperatively is highly recommended.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| panitumumab | Experimental | Drug: panitumumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ECOG Performance Status 0-1
- Histologically proven adenocarcinoma of the rectum, T3-T4 and/or N+ M0
- Wild-type KRAS
- No prior pelvic irradiation
- Normal bone marrow, hepatic, renal, cardiac functions
Key exclusion criteria (10 listed)
- KRAS mutation
- Established or suspected metastasis
- Prior pelvic irradiation
- Previous exposure to EGFR-targeting therapies
- Patients under any other investigational agent(s)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| panitumumabAlso: Vectibixintravenous infusion of panitumumab, 6 mg per kg body weight, once every 14 days for a total of 42 days | Drug | panitumumab |
Primary outcome
Pathological Complete Response (pCR)
Time frame: 11 weeks
1 secondary outcome
Safety, pathologic R0 resection, negative Circumferential Resection Margin, pathologic downstaging, tumor regression grade, quality of mesorectal excision, rate of sphincter-preservation, Disease-Free Survival, local control rate, translational research
Time frame: 24 months
Results and safety
The study was stopped early (reason given: The intermediate analyses did not allowed to continue the clinical study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Pascal H Machiels, MD, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing panitumumab in people with Rectal Cancer, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 8 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The intermediate analyses did not allowed to continue the clinical study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) (time frame: 11 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2016.