Colon Cancer Stage IIIPhase 3NCT04342676
Lymph Node Ratio and Kras Mutation in R Colon Cancer
A Phase 3 study testing k ras and Panitumumab in people with Colon Cancer Stage III, run by Mansoura University at 1 site in Egypt.
Trial summary
clinical impact of LN ratio with Kras expression in colon cancer Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Colon Cancer Stage III
- What is being tested?
- k ras and Panitumumab
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 433 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2017to 26 Aug 2019
- Phase
- Phase 3
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Stage III colon cancer
Who cannot join
- Stage I, II, IV
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University Oncology Center
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: Lymph Node Ratio and Kras Mutation in Risk Stratification of Colon Cancer
clinical impact of LN ratio with Kras expression in colon cancer
Read the detailed description
LNR and K ras were evaluated with correlated with different clinicopathological parameters of the patients, PFS and OS.
- Conditions
- Colon Cancer Stage III
- Being tested
- k ras, Panitumumab
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
k rasDevice
K ras
PanitumumabDrug
Also called vectibex
vectibex in stage iv
| Study group | Role | What they receive |
|---|---|---|
| patients | Experimental | LNR measured by (number of metastatic lymph nodes/total number of lymph nodes excised). and K ras (polymerase chain reaction (PCR) and pyrosequencing targeted for KRAS codons 12-13 was performed ) Receives: Device: k ras; Drug: Panitumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
LNR and K ras were evaluated with correlated with different clinicopathological parameters (Gender, CEA, tumor size, tumor grade and response to treatment).
impact on response
Measured: 2 years
Secondary outcomes (1)
LNR and K ras were evaluated and ASSOCIATION with PFS and OS.
impact on survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start10 Mar 2017
- Primary completion25 Aug 2019
- Study completion26 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon Cancer Stage IIIStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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 3
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 433 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tawfik A Elkhodary, MD, Study chair, Oncology Center Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342676
- Sponsor's protocol ID
- IRB 20202
- Status last verified
- Apr 2020
- First submitted
- 3 Apr 2020
- Last updated
- 13 Apr 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: after publication
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymph Node Ratio and Kras Mutation in Risk Stratification of Colon Cancer
- ClinicalTrials.gov ID
- NCT04342676
- Acronym / sponsor ID
- IRB 20202
- Conditions
- Colon Cancer Stage III
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 433 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 25 Aug 2019 (actual)
- Study completion
- 26 Aug 2019 (actual)
- First posted
- 13 Apr 2020 (actual)
- 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.
clinical impact of LN ratio with Kras expression in colon cancer
Detailed description
LNR and K ras were evaluated with correlated with different clinicopathological parameters of the patients, PFS and OS.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | Experimental | Device: k ras, Drug: PanitumumabLNR measured by (number of metastatic lymph nodes/total number of lymph nodes excised). and K ras (polymerase chain reaction (PCR) and pyrosequencing targeted for KRAS codons 12-13 was performed ) |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Stage III colon cancer
Key exclusion criteria (1 listed)
- Stage I, II, IV
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 |
|---|---|---|
| k rasK ras | Device | patients |
| PanitumumabAlso: vectibexvectibex in stage iv | Drug | patients |
Primary outcome
LNR and K ras were evaluated with correlated with different clinicopathological parameters (Gender, CEA, tumor size, tumor grade and response to treatment).
Time frame: 2 years
impact on response
1 secondary outcome
LNR and K ras were evaluated and ASSOCIATION with PFS and OS.
Time frame: 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 13 Apr 2020.
- Individual participant dataSharing planned: No. after publication
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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.
Tawfik A Elkhodary, MD study chair
Oncology Center Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing k ras and Panitumumab in people with Colon Cancer Stage III, run by Mansoura University at 1 site in Egypt.
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 1 inclusion and 1 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 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
LNR and K ras were evaluated with correlated with different clinicopathological parameters (Gender, CEA, tumor size, tumor grade and response to treatment). (time frame: 2 years). 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 13 Apr 2020.