ColoRectal CancerPhase 3INCISIVENCT02956876
Equivalence of Monitoring by a Nurse Practitioner for Patients With Digestive Cancer
A Phase 3 study testing standard chemotherapy for colorectal cancer, Nurse practitioner consultation and Medical practitioner consultation in people with ColoRectal Cancer, run by University Hospital, Rouen at 1 site in France.
Trial summary
With 42,150 new cases per year, colorectal cancer is the third cause of cancer in France according to the latest report from the Institut national du Cancer (INCa). Second leading cause of cancer death in men, its management is a public health problem. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ColoRectal Cancer
- What is being tested?
- standard chemotherapy for colorectal cancer, Nurse practitioner consultation and Medical practitioner consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteFrance
- Study dates
- 5 Dec 2016to 19 Nov 2022
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Digestive diagnostic of colorectal cancer.
- Treatment with intravenous chemotherapy or treatment with concomitant oral and intravenous chemotherapy.
- Patient beginning a cycle of chemotherapy he had already received chemotherapy sessions or not.
- Patient aged 18 or over.
- Patient with predictable life expectancy greater than 3 months.
- Patient speak and understand the French.
- Patient having read and understood the information letter and signed the consent form.
- For women of childbearing age: effective contraception 3 months before the start of treatment and negative blood pregnancy test
Who cannot join
- Patient aged over 80.
- Patient aged under 18.
- Prognosis committed within 3 months.
- Pregnant women or breastfeeding.
- Initial clinical assessment quoting fatigue to a higher grade 2 according to the WHO classification before the start of chemotherapy treatment.
- Against indication(s) for chemotherapy.
- Person deprived of liberty by an administrative or judicial decision or person under the protection of a conservator.
- History of disease or psychological or sensory abnormality that may prevent the patient to understand the requirements for participation in the protocol or preventing it from giving informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Equivalence of Monitoring by a Nurse Practitioner for Patients With Digestive Cancer, Requiring Intravenous Chemotherapy Versus a Medical Monitoring
With 42,150 new cases per year, colorectal cancer is the third cause of cancer in France according to the latest report from the Institut national du Cancer (INCa). Second leading cause of cancer death in men, its management is a public health problem. According to projections by WHO, the prevalence of cancers expected to increase 50% by 2050 especially in digestive oncology. These projections can be concluded that the demand for care will continue to be growing.
Medical advances and societal leading to increased life expectancy, have operated a mutation of the cancer disease. Formerly fatal disease, it is now a chronic disease in some cases. These changes are causing new challenges for the health system.
Read more
To address this problem, it is asked health professionals to adapt the organization of health care delivery to improve efficiency, in a constrained economic environment. To this end, action 4.1 of the cancer plan includes the creation of clinical nursing profession, a proposal reiterated in article 120 of the French Health System Law. Nursing clinicians will be empowered to ensure, under certain conditions, prescription treatments protocolized of follow-up tests, further treatment and support, as well as the extension or adaptation of specific treatments.
This project is a first step, in France, in thinking around new organizations in the supply of care in oncology.
For patients, strengthening their monitoring during chemotherapy, will better know their tolerance regarding chemotherapy. This optimized management of chemotherapy-induced effects will help reduce the use of emergency care.
The establishment of such a practitioner will free medical time to handle the most complex patients and perform tasks related to research.
For hospital pharmacies this type of organization will optimize their productivity by anticipating orders for chemotherapy pockets.
This project represents an opportunity to demonstrate the added value of advanced practice nurses in France in the health system and particularly in oncology. It also adds value to clinical expertise nurse and register the profession in the research.
The hypothesis is that the quality and safety of care provided by a nurse practitioner are equivalent to those provided by a doctor at follow-up of patients with gastrointestinal cancer, treated with intravenous chemotherapy.
- Conditions
- ColoRectal Cancer
- Being tested
- standard chemotherapy for colorectal cancer, Nurse practitioner consultation, Medical practitioner consultation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard chemotherapy for colorectal cancerDrug
standard chemotherapy for colorectal cancer
Nurse practitioner consultationOther
Nurse practitioner consultation will be done standard chemotherapy for colorectal cancer
Medical practitioner consultationOther
Medical practitioner consultation will be done standard chemotherapy for colorectal cancer.
| Study group | Role | What they receive |
|---|---|---|
| Nurse practitioner consultation | Experimental | standard chemotherapy for colorectal cancer Receives: Drug: standard chemotherapy for colorectal cancer; Other: Nurse practitioner consultation |
| Standard consultation | Other | standard chemotherapy for colorectal cancer Receives: Drug: standard chemotherapy for colorectal cancer; Other: Medical practitioner consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of side effects of chemotherapy for WHO grade greater than 2
Measured: Day 7
Secondary outcomes (2)
Quality of life of patients by QLQC-30 questionnaire
Measured: Day 7
Number of provisional chemotherapy orders
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study start5 Dec 2016
- Primary completion19 Nov 2022
- Study completion19 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColoRectal CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre MICHEL, Pr, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02956876
- Sponsor's protocol ID
- 2015/211/HP
- Acronym
- INCISIVE
- Status last verified
- Feb 2026
- First submitted
- 3 Nov 2016
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Equivalence of Monitoring by a Nurse Practitioner for Patients With Digestive Cancer, Requiring Intravenous Chemotherapy Versus a Medical Monitoring
- ClinicalTrials.gov ID
- NCT02956876
- Acronym / sponsor ID
- INCISIVE / 2015/211/HP
- Conditions
- ColoRectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 5 Dec 2016 (actual)
- Primary completion
- 19 Nov 2022 (actual)
- Study completion
- 19 Nov 2022 (actual)
- First posted
- 7 Nov 2016 (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.
With 42,150 new cases per year, colorectal cancer is the third cause of cancer in France according to the latest report from the Institut national du Cancer (INCa). Second leading cause of cancer death in men, its management is a public health problem. According to projections by WHO, the prevalence of cancers expected to increase 50% by 2050 especially in digestive oncology. These projections can be concluded that the demand for care will continue to be growing.
Medical advances and societal leading to increased life expectancy, have operated a mutation of the cancer disease. Formerly fatal disease, it is now a chronic disease in some cases. These changes are causing new challenges for the health system.
To address this problem, it is asked health professionals to adapt the organization of health care delivery to improve efficiency, in a constrained economic environment. To this end, action 4.1 of the cancer plan includes the creation of clinical nursing profession, a proposal reiterated in article 120 of the French Health System Law. Nursing clinicians will be empowered to ensure, under certain conditions, prescription treatments protocolized of follow-up tests, further treatment and support, as well as the extension or adaptation of specific treatments.
This project is a first step, in France, in thinking around new organizations in the supply of care in oncology.
For patients, strengthening their monitoring during chemotherapy, will better know their tolerance regarding chemotherapy. This optimized management of chemotherapy-induced effects will help reduce the use of emergency care.
The establishment of such a practitioner will free medical time to handle the most complex patients and perform tasks related to research.
For hospital pharmacies this type of organization will optimize their productivity by anticipating orders for chemotherapy pockets.
This project represents an opportunity to demonstrate the added value of advanced practice nurses in France in the health system and particularly in oncology. It also adds value to clinical expertise nurse and register the profession in the research.
The hypothesis is that the quality and safety of care provided by a nurse practitioner are equivalent to those provided by a doctor at follow-up of patients with gastrointestinal cancer, treated with intravenous chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse practitioner consultation | Experimental | Drug: standard chemotherapy for colorectal cancer, Other: Nurse practitioner consultationstandard chemotherapy for colorectal cancer |
| Standard consultation | Other | Drug: standard chemotherapy for colorectal cancer, Other: Medical practitioner consultationstandard chemotherapy for colorectal cancer |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Digestive diagnostic of colorectal cancer.
- Treatment with intravenous chemotherapy or treatment with concomitant oral and intravenous chemotherapy.
- Patient beginning a cycle of chemotherapy he had already received chemotherapy sessions or not.
- Patient aged 18 or over.
- Patient with predictable life expectancy greater than 3 months.
Key exclusion criteria (8 listed)
- Patient aged over 80.
- Patient aged under 18.
- Prognosis committed within 3 months.
- Pregnant women or breastfeeding.
- Initial clinical assessment quoting fatigue to a higher grade 2 according to the WHO classification before the start of chemotherapy treatment.
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 |
|---|---|---|
| standard chemotherapy for colorectal cancerstandard chemotherapy for colorectal cancer | Drug | Nurse practitioner consultation, Standard consultation |
| Nurse practitioner consultationNurse practitioner consultation will be done standard chemotherapy for colorectal cancer | Other | Nurse practitioner consultation |
| Medical practitioner consultationMedical practitioner consultation will be done standard chemotherapy for colorectal cancer. | Other | Standard consultation |
Primary outcome
Number of side effects of chemotherapy for WHO grade greater than 2
Time frame: Day 7
2 secondary outcomes
Quality of life of patients by QLQC-30 questionnaire
Time frame: Day 7
Number of provisional chemotherapy orders
Time frame: Day 7
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 6 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
Pierre MICHEL, Pr principal investigator
University Hospital, Rouen
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 standard chemotherapy for colorectal cancer, Nurse practitioner consultation and Medical practitioner consultation in people with ColoRectal Cancer, run by University Hospital, Rouen at 1 site in France.
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 8 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 6 Feb 2026. 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 France. 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?
Number of side effects of chemotherapy for WHO grade greater than 2 (time frame: Day 7). 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 6 Feb 2026.