Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Aflibercept

Angiogenesis Inhibitors

Growth Inhibitors

FOLFIRI and aflibercept (4 mg/m²) each 14 days until progression of disease

injection of FOLFIRI and Aflibercept every 14 days until progression of disease

FOLFIRI Protocol

Aflibercept Injection

Julien TAIEB, PhD

One of the treatments generally used to treat this disease is a chemotherapy called FOLFIRI. The purpose of this study is to improve the efficacy of the chemotherapy by adding a protein, similar to immunoglobulins, aflibercept, and to assess their tolerance.

Aflibercept is a protein that has already been studied in the treatment of metastatic colorectal cancers, in combination with a chemotherapy involving irinotecan in addition to 5FU (fluoropyrimidine) ( (FOLFIRI) as 2nd line treatment. It is marketed in Europe and it is authorized in the United States. Its addition to this chemotherapy combination has in fact brought about a benefit in terms of progression-free survival and overall survival.

The purpose of the study is to evaluate the efficacy and tolerance of this combination rather in the initial approach to the treatment of metastatic colorectal cancers and hence to evaluate it as 1st line treatment

Efficacy and Safety of Aflibercept in Combination With FOLFIRI Chemotherapy as 1st Line Treatment for Patients With Metastatic Colorectal Cancer

Progression was evaluated by CT scan, according to RECIST criteria (version 1.1) definition by the investigator. Death was also considered as an event (all causes).

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions compared the little sum of diameters observed during the study (NADIR), or a measurable increase in a non-target lesion, or the appearance of new lesions

Overall survival is defined as the time from the date of the patient's inclusion to the patient's death (all causes). For alive patients the date of the latest news is taken into account

The progression-free survival is the time from inclusion to the first radiological progression or death (all causes). For patients alive without progression date of last news will be considered.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions compared the little sum of diameters observed durin the study (NADIR), or a measurable increase in a non-target lesion, or the appearance of new lesions

Federation Francophone de Cancerologie Digestive

Toxicities were collected before each cure of treatment up to the end of the treatment. There is no fixed time-frame because of metastatic disease. The study treatment is given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)

FOLFIRI and aflibercept (4 mg/m²) each 14 days until progression of disease

FOLFIRI + Aflibercept: injection of FOLFIRI and Aflibercept every 14 days until progression of disease

FOLFIRI and Aflibercept

FOLFIRI and aflibercept (4 mg/m²) each 14 days until progression of disease

FOLFIRI Protocol: injection of FOLFIRI and Aflibercept every 14 days until progression of disease

Aflibercept Injection: injection of FOLFIRI and Aflibercept every 14 days until progression of disease

FOLFIRI + Aflibercept

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

France

Region of Enrollment

Mrs Karine Le Malicot, Head of biostatistics

Analyse was done on all the patients included in the study (ITT)

Rate of Patients Alive and Progression-free 6 Months After Inclusion.

Overall Survival

Progression-free Survival

Overall Study

Skin and Connective Tissue Diseases

Eye Diseases

Heart and Blood Diseases

Rare Diseases

Melanoma

Glaucoma

Glaucoma, Neovascular

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Hypertension

Ocular Hypertension

Ocular Melanoma

Neuroendocrine Tumor

Neuroepithelioma

Endothelial Growth Factors

Mitogens

Intravitreal injection of aflibercept 40mg/mL will be done on patients. The injections will be performed on the last day of the proton therapy, then 1 and 2 months later for the induction phase. During the maintenance phase, injections will be performed every 3 months for a period of 21 months.

A false injection will be done on patients on the last day of the proton therapy, then 1 and 2 months later for the induction phase. During the maintenance phase, falses injections will be performed every 3 months for a period of 21 months.

False injection

Stéphanie BAILLIF, Pr

The reference treatment of ocular melanoma is a conservative treatment by proton therapy. Its goal is to treat the tumor while preserving the eyeball and visual acuity. However, ablation of the eyeball is sometimes necessary after proton therapy in the case of neovascular glaucoma. This complication occurs in 7 to 47% of cases (depending on the size of the tumor) and is associated with hypersecretion of Vascular Endothelial Growth Factor (VEGF) related to necrotic and inflammatory tumor tissue after proton therapy or ischemic retina. The intravitreal injections of anti-VEGF are used in the treatment of neovascular radicular glaucoma without avoiding enucleation in all cases. The investigators propose to study the prevention of neovascular glaucoma by intravitreal prophylactic administration of anti-VEGF.

Prevention of Neovascular Glaucoma by Intravitreal Injections of Anti-VEGF in Patients Treated With Proton Therapy for a Large Choroidal Melanoma

Prevention of Neovascular Glaucoma by Intravitreal Injections of Anti-Vascular Endothelial Growth Factor in Patients Treated With Proton Therapy for a Large Choroidal Melanoma

Occurrence of neovascular glaucoma after radiation-induced proton therapy. Clinical diagnosis (examination at the slit lamp)

Centre Hospitalier Universitaire de Nice

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy and Safety of Aflibercept in Combination With FOLFIRI Chemotherapy as 1st Line Treatment for Patients With Metastatic Colorectal Cancer	NCT02181556	Metastatic Colo...	FOLFIRI Protoco... Aflibercept Inj...	18 Years -	Federation Francophone de Cancerologie Digestive
Prevention of Neovascular Glaucoma by Intravitreal Injections of Anti-VEGF in Patients Treated With Proton Therapy for a Large Choroidal Melanoma	NCT03172299	Ocular Melanoma	Aflibercept Inj... False injection	18 Years -	Centre Hospitalier Universitaire de Nice

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