Colon CancerPhase 2NCT01108107
Neoadjuvant Treatment of Colon Cancer
A Phase 2 study testing Oxaliplatin, Capecitabine and Panitumumab in people with Colon Cancer, run by Vejle Hospital at 3 sites in Denmark.
Trial summary
This study will investigate the effect of preoperative combination chemotherapy in patients with locally advanced colon cancer with mutation in the KRAS, BRAF or PIK3CA gene the effect of preoperative combination chemotherapy in combination with biological treatment in patients without mutation in the KRAS, BRAF or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Oxaliplatin, Capecitabine and Panitumumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 3 sitesDenmark
- Study dates
- Apr 2010to Mar 2015
- 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
- Histologically verified locally advanced T3 or T4 colon cancer assessed by CT scan
- Analysis of KRAS, BRAF, PIK3CA
- Age ≥18 år
- Performance status ≤ 2
- Hematology
- ANC ≥ 1.5x10^9/l. Thrombocytes ≥ 100x10^9/l.
Show all 11Show fewer
- Biochemistry
- Bilirubinaemia ≤ 3 x UNL. ALAT ≤ 5 x UNL
- Consent to translational research
- Fertile women must present a negative pregnancy test and use secure birth control during and 3 months after treatment.
- Written and orally informed consent.
Who cannot join
- Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment, active severe infections or other concurrent disease.
- Peripheral neuropathy NCI grade >1
- Other malignant disease within 5 years prior to enrollment, except basal cell squamous carcinoma of the skin and cervical carcinoma-in-situ
- Other investigational treatment within 30 days prior to treatment start
- History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
- Bleeding tumors
- Hypersensitivity to one or more of the substances
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Department of Oncology, Herlev Hospital
Herlev, DK-2730
Dept. of Oncology, Hilleroed Hospital
Hilleroed, 3400
Department of Oncology, Vejle Hospital
Vejle, DK-7100
About this study
Official title: Neoadjuvant Chemotherapy and Biological Treatment for Patients With Locally Advanced Colon Cancer
This study will investigate
- the effect of preoperative combination chemotherapy in patients with locally advanced colon cancer with mutation in the KRAS, BRAF or PIK3CA gene
- the effect of preoperative combination chemotherapy in combination with biological treatment in patients without mutation in the KRAS, BRAF or PIK3CA gene.
- Conditions
- Colon Cancer
- Being tested
- Oxaliplatin, Capecitabine, Panitumumab
- Keywords
- Colon cancer, Neoadjuvant treatment, KRAS mutation, BRAF mutation, PIK3CA mutation, Possibly avoid chemotherapy after operation
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
130 mg/m2 intravenously on day 1 of a 3-weekly cycle
CapecitabineDrug
2000 mg/m2/day (tablets) on day 1 and 14 of a 3-weekly cycle
OxaliplatinDrug
130 mg/m2 intravenously on day 1 of a 3-weekly cycle
CapecitabineDrug
2000 mg/m2/day (tablets) on day 1 and 14 of a 3-weekly cycle
PanitumumabBiological
9 mg/kg intravenously on day 1 of a 3-weekly cycle
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy only | Other | Chemotherapy only, if mutations in KRAS, BRAF or PIK3CA gene Receives: Drug: Oxaliplatin; Drug: Capecitabine |
| Chemotherapy + biological treatment | Other | Addition of biological treatment, if no mutations in KRAS, BRAF, and PIK3CA genes. Receives: Drug: Oxaliplatin; Drug: Capecitabine; Biological: Panitumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of patients requiring adjuvant chemotherapy based on the histological evaluation of the preparation from the operation.
Measured: Within 1 week after surgery
Secondary outcomes (2)
Recurrence free survival
Measured: Up to 2 years.
Overall survival
Measured: Up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2013
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev Hospital
- Responsible party
- Sponsor
- Investigators
- Anders Jakobsen, DMSc, Principal investigator, Vejle Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01108107
- Sponsor's protocol ID
- S-20100014
- Status last verified
- Mar 2014
- First submitted
- 14 Apr 2010
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dam C, Lund-Rasmussen V, Ploen J, Jakobsen A, Rafaelsen SR. Computed tomography assessment of early response to neoadjuvant therapy in colon cancer. Dan Med J. 2015 Jul;62(7):A5103.
PubMed 26183044
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemotherapy and Biological Treatment for Patients With Locally Advanced Colon Cancer
- ClinicalTrials.gov ID
- NCT01108107
- Acronym / sponsor ID
- S-20100014
- Conditions
- Colon Cancer
- Keywords
- Colon cancer, Neoadjuvant treatment, KRAS mutation, BRAF mutation, PIK3CA mutation, Possibly avoid chemotherapy after operation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Collaborators
- Herlev Hospital
- Study start
- Apr 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 21 Apr 2010 (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.
This study will investigate
- the effect of preoperative combination chemotherapy in patients with locally advanced colon cancer with mutation in the KRAS, BRAF or PIK3CA gene
- the effect of preoperative combination chemotherapy in combination with biological treatment in patients without mutation in the KRAS, BRAF or PIK3CA gene.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy only | Other | Drug: Oxaliplatin, Drug: CapecitabineChemotherapy only, if mutations in KRAS, BRAF or PIK3CA gene |
| Chemotherapy + biological treatment | Other | Drug: Oxaliplatin, Drug: Capecitabine, Biological: PanitumumabAddition of biological treatment, if no mutations in KRAS, BRAF, and PIK3CA genes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically verified locally advanced T3 or T4 colon cancer assessed by CT scan
- Analysis of KRAS, BRAF, PIK3CA
- Age ≥18 år
- Performance status ≤ 2
- Hematology
Key exclusion criteria (7 listed)
- Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment, active severe infections or other concurrent disease.
- Peripheral neuropathy NCI grade >1
- Other malignant disease within 5 years prior to enrollment, except basal cell squamous carcinoma of the skin and cervical carcinoma-in-situ
- Other investigational treatment within 30 days prior to treatment start
- History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
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 |
|---|---|---|
| Oxaliplatin130 mg/m2 intravenously on day 1 of a 3-weekly cycle | Drug | Chemotherapy only |
| Capecitabine2000 mg/m2/day (tablets) on day 1 and 14 of a 3-weekly cycle | Drug | Chemotherapy only |
| Oxaliplatin130 mg/m2 intravenously on day 1 of a 3-weekly cycle | Drug | Chemotherapy + biological treatment |
| Capecitabine2000 mg/m2/day (tablets) on day 1 and 14 of a 3-weekly cycle | Drug | Chemotherapy + biological treatment |
| Panitumumab9 mg/kg intravenously on day 1 of a 3-weekly cycle | Biological | Chemotherapy + biological treatment |
Primary outcome
The frequency of patients requiring adjuvant chemotherapy based on the histological evaluation of the preparation from the operation.
Time frame: Within 1 week after surgery
2 secondary outcomes
Recurrence free survival
Time frame: Up to 2 years.
Overall survival
Time frame: Up to 2 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
- Derived from this study: PubMed 26183044Dam C, Lund-Rasmussen V, Ploen J, Jakobsen A, Rafaelsen SR. Computed tomography assessment of early response to neoadjuvant therapy in colon cancer. Dan Med J. 2015 Jul;62(7):A5103.
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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.
Anders Jakobsen, DMSc principal investigator
Vejle Hospital
3 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 Oxaliplatin, Capecitabine and Panitumumab in people with Colon Cancer, run by Vejle Hospital at 3 sites in Denmark.
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 11 inclusion and 7 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: finished, as of the sponsor's last update on 21 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The frequency of patients requiring adjuvant chemotherapy based on the histological evaluation of the preparation from the operation. (time frame: Within 1 week after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01108107, which also lists 1 linked publication.
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 21 May 2015.