NCT02956876: INCISIVE

Equivalence of Monitoring by a Nurse Practitioner for Patients With Digestive Cancer

Completed Phase 3 Last updated 6 February 2026

What this trial tests

Phase 3 trial testing standard chemotherapy for colorectal cancer in ColoRectal Cancer in 207 participants. Completed in 19 November 2022.

Timeline

5 December 2016

Primary endpoint
19 November 2022

19 November 2022

Quick facts

Lead sponsor	University Hospital, Rouen
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Primary purpose	treatment
Enrollment	207
Start date	5 December 2016
Primary completion	19 November 2022
Estimated completion	19 November 2022
Sites	1 location across France

Drugs / interventions tested

• standard chemotherapy for colorectal cancer — full drug profile →
• Nurse practitioner consultation
• Medical practitioner consultation

Conditions studied

• ColoRectal Cancer — all drugs for ColoRectal Cancer →

Sponsor

University Hospital, Rouen

Who can join

Adults 18 to 80, any sex, with ColoRectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.