Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasm Metastasis

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplastic Processes

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Bevacizumab

Antibodies

Antibodies, Monoclonal

Cetuximab

Angiogenesis Inhibitors

Immunoglobulins

Liver Extracts

Antineoplastic Agents, Immunological

Growth Inhibitors

cetuximab

bevacizumab

Jean-Alain Chayvialle, MD

Primary Objective: This trial is elaborating a model for rapidly predicting (day 21) the response to monoclonal antibodies anti-EGFR and anti-VEGF (cetuximab and bevacizumab) based on biological markers and/or functional imaging. The response to treatment is evaluated by the conventional method after 2 months (Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria).

Secondary Objectives:

1. This trial is also analyzing the correlation between the magnitude of response to treatment at 2 months (stabilization or objective response, RECIST criteria) and that of response observed after 6 months of treatment.
2. The organisational objective is to develop a tumour bank of metastatic colorectal cancer.

Population: The population includes 252 male and female patients with metastatic colorectal cancer justifying the use of cetuximab or bevacizumab, with no heart disease.

Techniques: Computed tomography (CT scan), functional imaging (ultrasound with SonoVue); molecular imaging (positron emission tomography \[PET\] with fluorodeoxyglucose F18 \[18-FDG\]); and biology and pathology on microbiopsy of liver metastasis are used.

Outcome Criteria: The primary outcome is response to treatment with monoclonal antibodies according to RECIST criteria at two months.

Studied Factors:

Radiology:

1. CT scan: RECIST criteria (gold standard);
2. Ultrasound with SonoVue injection: 1 representative target (delay of contrast appearance, peak of rising, curve of increase and decrease of the signal, area under the curve, time of average transit).

Nuclear Medicine: PET scan and 18-FDG (standard uptake values \[SUV\])

Molecular Characterization of Tumors: p53 status; microsatellite instability (MSI) status; expression of oncogenes; EGFR status; VEGF status; determination of FcgammaRIIIA polymorphisms

Statistics:

1. Descriptive analyses;
2. Analysis of the appropriate threshold to measure: response to treatment by an ultrasound with SonoVue and by PET scan; correlation between response predicted by the ultrasound with SonoVue and the PET; conventional morphological CT at 2 months
3. Analysis of prognostic factors:

   1. Evaluation of the role of each prognostic factor (pathology and imaging) on response to treatment;
   2. Multivariate analysis of prognostic factors;
   3. Analysis of the prognostic power of early response at 2 months on the response observed after 6 months of treatment.

Elaboration of a Model for Predicting Efficacy of Monoclonal Antibodies (Cetuximab and Bevacizumab) in Patients With Colorectal Cancer and Liver Metastases

Hospices Civils de Lyon

Jean-Alain CHAYVIALLE, Pr

Amino Acids

Irinotecan

Tyrosine Kinase Inhibitors

Topoisomerase I Inhibitors

Enzyme Inhibitors

Tyrosine

irinotecan and cetuximab in combination with pazopanib.

Pazopanib is a potent, multi-targeted tyrosine kinase inhibitor of VEGFR-1, -2, -3, PDGFR-alpha and -beta and c-kit.

Pazopanib

Cetuximab will be supplied as a single-use 50 milliliter vial containing 100 micrograms of cetuximab as a sterile, preservative-free, injectable liquid at a concentration of 2 milligram per milliliter in phosphate.

buffered saline

Irinotecan hydrochloride trihydrate is an antineoplastic agent of the topoisomerase I inhibitor class.

GSK Clinical Trials

Subjects will be entered into cohorts of 3 for the dose escalation phase so that the maximum tolerated dose can be determined. 18 additional patients will be recruited once the maximum tolerated dose (MTD) is determined for disease assessment.

Study of Pazopanib, Irinotecan and Cetuximab in Combination to Treat 2nd Line Metastatic Colorectal Cancer

Phase I Study of Safety and Pharmacokinetics of Pazopanib in Combination With Cetuximab and Irinotecan in Patients With Colorectal Cancer

GlaxoSmithKline

Fluorouracil

Oxaliplatin

Induction FOLFOXIRI plus cetuximab will consist of:

* CETUXIMAB 500 mg/sqm IV over 1-h\* , day 1 followed by
* IRINOTECAN 130 mg/sqm IV over 1-h, day 1 followed by
* OXALIPLATIN 85 mg/sqm IV over 2-h, day 1 concomitantly with
* l-LV 200 mg/sqm IV over 2-h, day 1 followed by
* 5-FLUOROURACIL 2400 mg/sqm IV 48-h continuous infusion, starting on day 1 repeated every 2 weeks for 8 cycles.

Surgical revaluation will be performed after the induction phase (8 cycles).

Patients deemed unsuitable for surgery will received maintenance treatment as follows:

•CETUXIMAB 500 mg/sqm IV over 60-min, day 1 repeated every 2 weeks until PD, patient's refusal, unacceptable toxicity or consent withdrawal.

Induction FOLFOXIRI plus cetuximab will consist of:

* CETUXIMAB 500 mg/sqm IV over 1-h\* , day 1 followed by
* IRINOTECAN 130 mg/sqm IV over 1-h, day 1 followed by
* OXALIPLATIN 85 mg/sqm IV over 2-h, day 1 concomitantly with
* l-LV 200 mg/sqm IV over 2-h, day 1 followed by
* 5-FLUOROURACIL 2400 mg/sqm IV 48-h continuous infusion, starting on day 1 repeated every 2 weeks for 8 cycles.

Surgical revaluation will be performed after the induction phase (8 cycles).

Patients deemed unsuitable for surgery will received maintenance treatment as follows:

•BEVACIZUMAB 5 mg/kg IV over 30-min, day 1 repeated every 2 weeks until PD, patient's refusal, unacceptable toxicity or consent withdrawal.

folfoxiri+cetuximab+surgery+cetuximab

folfoxiri+cetuximab+surgery+bevacizumab

Alfredo Falcone, MD

This is a phase II randomized study of 4-months induction first-line chemotherapy with FOLFOXIRI + cetuximab followed by maintenance with cetuximab or bevacizumab in patients affected by KRAS wild type (wt) mCRC.

The aim of the study is to obtain a rapid disease control with the therapy and the maximum tumoral shrinkage, and than to treat patient with less intensive maintenance to inhibit tumoral regrowth.

Induction Chemoterapy With Folfoxiri Plus Cetuxumab in Unresectable Colorectal Cancer Patient

Induction Chemotherapy With Folfoxiri Plus Cetuximab and Maintenance With Cetuximab or Bevacizumab Therapy in Unresectable Kras Wild-type Metastatic Colorectal Cancer Patients

10m-PFR is defined as the proportion of patients free from disease progression 10 months after randomization, relative to the total of enrolled patients. Patients whose disease status cannot be evaluated within 11 months after randomization and patients lost to follow up or dead within 10 months after randomization will be considered as progressed for the purpose of the primary endpoint analyses.

Best overall response rate is defined as the percentage of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria, during the induction and the maintenance phases of treatment. The determination of clinical response will be based on investigator reported measurements that will be subsequently confirmed by a central review. Responses will be evaluated every 8 weeks until disease progression or up to 60 months. Patients who do not have an on-study assessment will be included in the analysis as non responders.

10month resection rate is defined as the percentage of patients,relative to the total of enrolled subjects,undergoing secondary R0 resection of metastases within 10months after randomization.Secondary R0 surgery is defined as microscopically margin free complete surgical removal of all residual disease,performed during treatment or after its completion,allowed by tumoral shrinkage and/or disappearance of 1or more lesions.Patients lost to follow up,with disease progression or dead,within 10months after randomization,will be considered as failures.

It is defined as the time from randomization to one of the followings:

1. progression during FOLFOXIRI + cetuximab or during a modified FOLFOXIRI + cetuximab regimen;OR
2. progression and decision to not administer FOLFOXIRI + cetuximab or a modified FOLFOXIRI + cetuximab regimen
3. introduction of a new agent not included in the study treatment according to randomization arm;OR
4. death; whichever occurs first.All events will be assessed up to 60 months.For patients still on treatment at the time of analysis, the time to strategy failure will be censored on the last date the patients were known to be alive.

It is defined as the time from randomization to 2°documentation of objective disease progression or death due to any cause,whichever occurs first.All events will be assessed up to 60 months.Time to 2nd progressive disease will be censored on the date of the last evaluable on study tumor assessment documenting absence of progressive disease for patients who are alive,on study and second progression free at the time of the analysis.Alive patients having no tumor assessments after baseline will have time to event endpoint censored on the date of randomization

It is defined as the time from randomization to first documentation of objective disease progression or death due to any cause,whichever occurs first. All events will be assessed up to 60 months. PFS will be censored on the date of the last evaluable on study tumor assessment documenting absence of progressive disease for patients who are alive,on study and progression free at the time of the analysis.Alive patients having no tumor assessments after baseline will have time to event endpoint censored on the date of randomization

It is defined as the time from randomization to the date of death due to any cause. All events will be assessed up to 60 months. For patients still alive at the time of analysis, the OS time will be censored on the last date the patients were known to be alive.

It is defined as the percentage of patients,relative to the total of enrolled subjects,experiencing a specific adverse event of grade 3/4,according to National Cancer Institute Common Toxicity Criteria (version 4.0),during the induction and the maintenance phases of treatment.

It is defined as the percentage of patients, relative to the total of enrolled subjects, experiencing any adverse event of grade 3/4, according to National Cancer Institute Common Toxicity Criteria (version 4.0), during the induction and the maintenance phases of treatment.

Gruppo Oncologico del Nord-Ovest

LGK974

Phase l: Dose Escalation phase; Phase ll: SIngle group assessing the triple combination of WNT974, LGX818 and cetuximab

WNT974

LGX818

Clinical Trial Call Center

The purpose of this study is to assess the safety and anti-tumor activity of the triple combination of WNT974, LGX818 and cetuximab in BRAFV600-mutant mCRC with RNF43 mutations or RSPO fusions.

The design of this study is based upon the translational and pre-clinical data that suggest that Wnt pathway signals, increased due to RNF43 mutations or RSPO fusions, cooperate with the EGFR and BRAF signals to maintain the growth of BRAFV600 CRCs. Inhibition of these signals with the triple combination of WNT974, LGX818 and cetuximab may result in anti-tumor activity.

Study of WNT974 in Combination With LGX818 and Cetuximab in Patients With BRAF-mutant Metastatic Colorectal Cancer (mCRC) and Wnt Pathway Mutations

A Phase Ib/II Multi-center, Open Label, Dose Escalation Study of WNT974, LGX818 and Cetuximab in Patients With BRAFV600-mutant KRAS Wild-type Metastatic Colorectal Cancer Harboring Wnt Pathway Mutations

Phase Ib: To estimate the MTD(s) and/or RP2D(s) of the triple combination of WNT974, LGX818 and cetuximab in patients with BRAFV600-mutant, KRAS wild-type (WT) mCRC harboring upstream Wnt pathway mutations.

Phase II: To estimate the preliminary anti-tumor activity of the RP2D(s) of the combination of WNT974, LGX818 and cetuximab in patients with BRAFV600-mutant metastatic CRC harboring upstream Wnt pathway mutations

To assess additional parameters of clinical activity of WNT974 in combination with LGX818 and cetuximab in BRAFV600-mutant mCRC with evidence of upstream Wnt pathway activation.

To characterize the pharmacokinetics (PK) of WNT974, its pharmacologically active metabolite LHA333, and LGX818 when used in combination therapy with cetuximab

To characterize the safety and tolerability of WNT974 in combination with LGX818 and cetuximab in patients with BRAFV600-mutant mCRC with evidence of upstream Wnt pathway activation

Phase Ib/II: To assess the pharmacodynamic effect of WNT974, LGX818 in combination with cetuximab and a potential relationship with clinical outcome

Array BioPharma

Mouth and Tooth Diseases

Stomatitis

Mucositis

Gastroenteritis

Mouth Diseases

Stomatognathic Diseases

Pharmaceutical Solutions

Fluorides

1.Correct method of brush Platelet value suitable for tooth brushing Feature of toothbrush (soft, nylon bristled, rounded tip, standard size) Fluoride toothpaste, its amount and use in dry brushes In toothbrush 45 degree, the contact of the bristles with the gums, 4 times contact with the inner, outer, chewing surface, tongue cleaning The benefits of correct brushing (preventing dental plaque and gingival recession, etc.) Importance of brushing teeth twice a day (breakfast and after dinner) Preparation of mouth wash Boiled and cooled water at 100°C Putting 5 measures of boiled and cooled water in a teacup with the 20 ml measuring cup provided.

Adding 1 teaspoon (6 g) of sodium bicarbonate to water Making a mouthwash Teaching how to gargle with 20 ml of bicarbonate 4 times a day at 6-hour intervals and being asked to spit it out without swallowing,

Correct method of brush Preparation of the mouthwash Boiled and cooled water at 100°C Putting 4 ml of water in the 5 ml measuring cup given to the patient Putting Ankaferd Blood Stopper on the remaining 1 ml portion of the 5 ml beaker Giving information about making and using mouthwash Use on an empty stomach 2 hours before meals in the morning and at least 2 hours after dinner After rinsing your mouth thoroughly with a mouthwash containing 5 ml of Ankaferd Blood Stopper prepared 2 times a day, you can swallow the solution in your mouth.

It is said that there is a solution-related discoloration in the mouth and teeth, but that it will return to its original state after tooth brushing.

Ankaferd Blood Stopper

Bicarbonate

Hicran Yıldız

The purpose of oral care is to reduce the effect of oral pathological microbial flora and to prevent infection, pain, and bleeding associated with cancer treatment. New agents are introduced each day to be used in the prevention and treatment of mucositis in cancer treatment. One of those agents is the Ankaferd Hemostat. Ankaferd Hemostat has pleiotropic effects and anti-infective characteristics in tissue healing. The aim of this study is to evaluate the effectiveness of the Ankaferd Hemostat in the prevention of oral mucositis due to chemotherapy in adult patients diagnosed with colorectal cancer.

The study was designed as a randomized controlled experimental study to be conducted with patients who are recently diagnosed with colorectal cancer and will receive the first course of chemotherapyd. The data were collected using the Performance Score and the Oral Mucositis Evaluation Scale.

In patients with colorectal cancer, it is important to perform symptom management dynamically as well as specific treatments for cancer. It is extremely important for healthcare professionals to know the approaches that can be recommended to patients in the management of treatment and disease-related symptoms, in order to prevent problems that may develop in patients due to the severity of symptoms. Controlling the symptoms will increase the patient's functional capacity and quality of life.

Oral mucositis is one of the common toxic effects of chemotherapy. Pain due to mucositis causes anorexia-dysphagia development and malnutrition. As a result, systemic infections can develop, dose reduction in chemotherapy courses, increase in cost and prolongation of hospital stay. Looking at the literature, chloroxidine, glutamine, palifermin was used to prevent the development of mucositis during 5-Fu-based therapy for colon cancer. Solutions such as bicarbonate were used. Although it was determined in these studies to prevent the development of oral mucositis, the incidence of mucositis is still high. Therefore, the search for new treatments and applications to prevent mucositis continues. Ankaferd Hemostat is a herbal product used as a hemostatic agent in traditional Turkish medicine. Ankaferd Hemostat affects endothelium, blood cells, angiogenesis, cellular reproduction and vascular dynamics and stimulates mediators that lead to rapidly progressive wound healing. In addition to these, the anti-inflammatory, antimicrobial, antifungal and antioxidative effects of Ankaferd Hemostat are mentioned in the literature. In order to determine the effectiveness of Ankaferd Hemostat application in chemotherapy-induced oral mucositis in adult patients, there is a single study conducted on 20 patients with mucositis grade 2-3 with hematological malignancy. While it is stated in the literature that the healing time of mucositis is the week after 7-14 days, it was seen that this decreased to 6.6 (3-10) days in the study conducted by Atay.

In another study conducted in the field of dentistry, the effectiveness of Ankaferd Hemostat in preventing the development of oroantral fistula was evaluated. In a study comparing the use of Platelet Rich Plasma (PRP) in one arm and Ankaferd Hemostat in the other arm, it was found that the antibacterial effect was more prominent in the Ankaferd Hemostat arm and the results of edema, bleeding and infection were similar in both arms .

The study was designed as a randomized controlled experimental study on patients newly diagnosed with colorectal cancer who would receive the first course of FOLFOX combination chemotherapy.

Which patients would be assigned to the study or control group was determined with the support of a person who was independent of the study and had no knowledge of the research. This person, who had no knowledge about the research, was asked to specify a number, and in the next process, patients were assigned to the study or control group depending on whether the random number was even or odd. Study and control group patients were first evaluated in terms of inclusion criteria. The Consolidated Reporting Trials (CONSORT) diagram was used to randomize patients. The use of the consort diagram has been used to greatly improve the conduct and reporting of randomized controlled trials and to allow the study to be included in future meta-analyses.

The Effects of Ankaferd Blood Stopper

The Effects of Ankaferd Hemostat on Preventing Oral Mucositis in Colorectal Cancer Patients Receiving Chemotherapy

It is a grading system developed by WHO according to the clinical appearance and functional status of mucositis. WHO evaluates oral mucositis (OM) as subjective (patient-described pain), objective (presence of erythema and ulcerations) and functional (ability to consume liquid/solid foods by mouth or inability to eat anything). OM grade 0 (normal), grade 1 \[mild focal changes (erythematous areas) no pain and tenderness yet, can be fed orally\], grade 2 (painless ulcers, erythema, mild pain sensation), grade 3 (painful erythema, edema or ulcers) (depth \>2 mm and less than half of the mucosa) no bleeding, can only be fed orally with liquid diet) and grade 4 (erythema, edema or ulcers (more than half the mucosa), severe pain, bleeding, no nutrition, parenteral and enteral nutrition support may be required)

Patients were informed about the precaution of oral hygiene. The patients were instructed to brush their teeth at least twice a day, morning and evening. Toothbrushes with soft nylon bristles with rounded ends were given to the patients. Modified Stillman method for tooth brushing was taught. The bristle ends of the brush should be placed in the apical direction, against the cervical part of the teeth and partially against the adjacent gingiva (it should be activated with a back-and-forth motion at least 4 times on each tooth at an angle of 450 and simultaneously move it in the coronal direction (from bottom to top, from right to left). announced.

This form, which was created as a result of literature review by the researchers at the beginning of the study, was prepared for both the study and control group patients included in the sample. It consists of 12 questions including brushing habits and the person responsible for its care) and health status and habits (having another chronic disease, smoking and alcohol use).

The Eastern Cooperative Oncology Group (ECOG) performance scale, also known as the WHO or Zubrod performance score, was developed in 1960. On the ECOG Performance scale, 0 means normal health and 5 means death. Low scores indicate good general condition, while high scores indicate poor prognosis. '0' Normal. Can maintain normal activity before the disease, '1' Can continue his daily life with bearable tumor findings, '2', Has disturbing tumor findings but spends more than 50% of his time out of bed, '3' Is severely disturbed and spends % of his time It is evaluated as '4' Being in a very uncomfortable condition and spending all his time tied to the bed, '5' Dead, who had to stay more than 50 of them tied to the bed.

This form was developed by the researchers in order to ensure that patients' oral care intervals, tooth brushing and mouthwash are made and to prevent them from being forgotten. It was used to record the oral care performed by the patients in the intervention and control groups during the follow-up period. The form is a checklist to be filled by clicking after oral care.

hemoglobin, hematocrit, neutrofil, body mass index

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Elaboration of a Model for Predicting Efficacy of Monoclonal Antibodies (Cetuximab and Bevacizumab) in Patients With Colorectal Cancer and Liver Metastases	NCT00327093	Colorectal Canc... Neoplasm Metast...	cetuximab bevacizumab	18 Years - 75 Years	Hospices Civils de Lyon
Study of Pazopanib, Irinotecan and Cetuximab in Combination to Treat 2nd Line Metastatic Colorectal Cancer	NCT00540943	Neoplasms, Colo...	Pazopanib Cetuximab Irinotecan	18 Years -	GlaxoSmithKline
Induction Chemoterapy With Folfoxiri Plus Cetuxumab in Unresectable Colorectal Cancer Patient	NCT02295930	Metastatic Colo...	folfoxiri+cetux... folfoxiri+cetux...	18 Years - 75 Years	Gruppo Oncologico del Nord-Ovest
Study of WNT974 in Combination With LGX818 and Cetuximab in Patients With BRAF-mutant Metastatic Colorectal Cancer (mCRC) and Wnt Pathway Mutations	NCT02278133	Metastatic Colo...	WNT974 LGX818 Cetuximab	18 Years -	Array BioPharma
Study of Pazopanib, Irinotecan and Cetuximab in Combination to Treat 2nd Line Metastatic Colorectal Cancer	NCT00540943	Neoplasms, Colo...	Pazopanib Cetuximab Irinotecan	18 Years -	GlaxoSmithKline
Study of WNT974 in Combination With LGX818 and Cetuximab in Patients With BRAF-mutant Metastatic Colorectal Cancer (mCRC) and Wnt Pathway Mutations	NCT02278133	Metastatic Colo...	WNT974 LGX818 Cetuximab	18 Years -	Array BioPharma
Induction Chemoterapy With Folfoxiri Plus Cetuxumab in Unresectable Colorectal Cancer Patient	NCT02295930	Metastatic Colo...	folfoxiri+cetux... folfoxiri+cetux...	18 Years - 75 Years	Gruppo Oncologico del Nord-Ovest
The Effects of Ankaferd Blood Stopper	NCT05438771	Colon Cancer Oral Mucositis Nurse's Role Chemotherapy Ef...	Ankaferd Blood ... Bicarbonate	18 Years - 75 Years	Uludag University

Spots Global Cancer Trial Database for colorectal cancer,