Symptoms and General Pathology

Wounds and Injuries

All Conditions

Neoplasms

Digestive System Diseases

Hyperthermia

Flushing

Fever

Carcinoma

Peritoneal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Oxaliplatin

Patients with a diagnosis of peritoneal carcinomatosis who undergo HIPEC treatment with oxaliplatin.

HIPEC with flushing afterwards

NO flushing with saline fluid after HIPEC

HIPEC without flushing afterwards

Currently, there is a lack of knowledge on the effect of additional flushing after HIPEC on tumour platinum exposure, systemic platinum exposure and platinum concentration in drain exudate and thereby personal exposure. Therefore the investigators want to perform a study to investigate the effect of flushing after HIPEC on tumour exposure, systemic exposure and on wound exudate concentration.

Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC) is standard care in the treatment of patients with peritoneal carcinomatosis as a result of intra-abdominal cancers. In many (inter)national centres oxaliplatin is used for the primary HIPEC treatment. Although the oxaliplatin dose of 460mg/m2 is widely accepted, the exact procedure of HIPEC differs between institutions and surgeons. Due to a great variety in the volume of the abdominal cavity, platinum concentration in the perfusate might differ between patients. Moreover, there is no consensus about the usefulness of flushing the HIPEC system with crystalloids at the end of oxaliplatin administration. Flushing is predominantly performed with the idea to minimize both systemic exposure of ultrafilterable platinum and personnel exposure to platinum contaminated exudate. On the other hand, HIPEC without flushing might increase effectiveness because intraperitoneal tumour cells are exposed to high concentrations of oxaliplatin for a longer time period. The option of flushing is based on an individual preference of the surgeon. Currently, there is a lack of knowledge on the effect of flushing on tumour platinum exposure, systemic platinum exposure and platinum concentration in drain exudate and thereby personal exposure. Therefore the investigators want to perform a study to investigate the effect of flushing after HIPEC on tumour exposure, systemic exposure and on wound exudate concentration.

peritoneal tissue samples, blood samples, instillate samples and wound exudate samples will be collected from the patients

Clinical Pharmacology of Platinum-based Hyperthermic Intraperitoneal Chemotherapy

Clinical pharmacoloGy of platinUm-based hyperThermic Intraperitoneal Chemotherapy: Exploration of the Impact of Flushing on tumOur, Systemic and Personnel eXposure (GUTOX)

Change in tissue platinum exposure of non-tumour peritoneal tissue sample before and after flushing with saline

platinum concentration in wound exudate samples will be measured in the drains

systemic exposure of total and unbound platinum will be measured using 13 blood samples

total and unbound platinum concentration in instillate will be measured in 3 samples of instillate solution that will be obtained during the HIPEC procedure

Radboud University Medical Center

Substance Related Disorders

Rare Diseases

Syndrome

Diarrhea

Neuroendocrine Tumors

Carcinoid Tumor

Malignant Carcinoid Syndrome

Serotonin Syndrome

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Adenocarcinoma

Neoplasms, Nerve Tissue

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Neuroendocrine Tumor

Carcinoid Syndrome

Neuroepithelioma

Pharmaceutical Solutions

Lanreotide

Somatostatin

Hormones

Hormone Antagonists

Subjects received deep s.c. lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).

After completing the DB phase (or if they met criteria for early roll over \[ERO\]) the subjects entered the IOL phase during which they received lanreotide Autogel 120 mg deep s.c. every 4 weeks for 32 weeks. During the LTOLE phase, subjects continued treatment with lanreotide Autogel 120 mg deep s.c. every 4 weeks until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained \[whichever occurred first\]).

Subjects received deep s.c. placebo every 4 weeks (±3 days) for 16 weeks (DB phase).

After completing the DB phase (or if they met criteria for ERO) the subjects entered the IOL phase during which they received lanreotide Autogel 120 mg deep s.c. every 4 weeks for 32 weeks. During the LTOLE phase, subjects continued treatment with lanreotide Autogel 120 mg deep s.c. every 4 weeks until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained \[whichever occurred first\]).

deep s.c. injection, 120 mg, every 4 weeks (±3 days).

deep s.c. injection of placebo (0.9% saline solution) every 4 weeks (±3 days) for 16 weeks, then deep s.c. injection of lanreotide 120 mg, every 4 weeks (±3 days).

Placebo

Ipsen Medical Director

The purpose of this study was to determine whether monthly deep subcutaneous (s.c.) injections of lanreotide Autogel (Somatuline Depot) were effective and safe in controlling diarrhoea and flushing by reducing the usage of s.c. short-acting octreotide as a rescue medication to control symptoms in subjects with carcinoid syndrome.

This study consisted of a Screening period, conducted up to 4 months before randomisation, followed by three phases: a 16-week, double blind (DB), randomised, placebo-controlled phase; a 32-week initial open label (IOL) phase; and a long term open label extension (LTOLE) phase.

The DB phase evaluated lanreotide Autogel versus placebo in subjects with a history of carcinoid syndrome (flushing and/or diarrhoea). This was followed by a 32-week IOL phase in which all subjects received lanreotide Autogel 120 mg every 4 weeks. Subjects in countries where lanreotide Autogel had not been approved for the treatment of carcinoid syndrome, who were well-controlled at the end of the 32-week IOL phase and chose to continue to receive lanreotide Autogel, were given the option of participating in a LTOLE phase. The LTOLE phase of the study was planned to end at least 2 years after the last subject had completed his/her participation in the 32-week IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome had been obtained in the respective countries (whichever occurred first) or at any time the study was terminated by the Sponsor. The actual overall duration of the study was 6.5 years. During the LTOLE phase all subjects continued to be treated with lanreotide Autogel 120 mg every 4 weeks.

The study planned to enrol approximately 100 adult subjects worldwide. Screening continued until 115 subjects were enrolled in the study.

An Efficacy and Safety Study of Somatuline Depot (Lanreotide) Injection to Treat Carcinoid Syndrome

A Double Blind, Randomized Placebo Controlled Clinical Trial Investigating the Efficacy and Safety of Somatuline Depot (Lanreotide) Injection in the Treatment of Carcinoid Syndrome

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

Use of s.c. octreotide required to control symptoms associated with carcinoid syndrome, measured as the percentage of days that s.c. octreotide was used as rescue medication, based on subject Interactive Voice Response System (IVRS) or Interactive Web Response System (IWRS) diary records.

Usage of other concomitant rescue medications for diarrhoea and/or flushing events, measured as the percentage of days that the medications were used as rescue medication based on subject IVRS/IWRS diary records. Subjects were required to record the use and dose of s.c. octreotide, if any, as well as the use of other concomitant rescue medications (e.g. loperamide 2 mg tabs, and/or tincture of opium).

Subjects who rolled over early were those who received less than four DB injections before receiving the first IOL injection.

Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.

Q29 and Q30 range from 1 (Very poor) to 7 (Excellent) with 1 being worst case and 7 the most favourable answer. Scores were derived according to the rules contained within the EORTC scoring manual. All of the scores range in score from 0 to 100. A high score for global health status/QoL represents high QoL. The principle for scoring the scale is: Estimate the average of the items (I1, I2, ..., In) that contribute to the scale; this is the raw score. Raw score = RS = (I1 + I2 +...+ In)/n.

For global health status/QoL: Score = {(RS - 1)/range} x 100, where range is the difference between the maximum possible value of RS and the minimum possible value of RS.

Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.

The QLQ-G.I.NET21 questionnaire contains 21 single items (Q31 to Q51) which are supplemental items to the EORTC QLQ-C30 questionnaire. Q31 to Q51 range from 1 to 4 with 1 being the most favourable answer and 4 the worst case (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much). Based on these items the scores were generated. All of the scores range in score from 0 to 100. A high score for a symptom scale represents a high level of symptomatology. The principle for scoring the scale is: Estimate the average of the items (I1, I2, ..., In) that contribute to the scale; this is the raw score. RS = (I1 + I2 +...+ In)/n.

For symptom scales: Score = {(RS - 1)/range} x 100, where range is the difference between the maximum possible value of RS and the minimum possible value of RS.

Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.

Ipsen

Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo.

Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.

Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase.

Lanreotide Autogel (Somatuline Depot) 120 mg (DB Phase)

Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase.

Placebo (DB Phase)

All 101 subjects in the IOL phase received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks (56 and 45 of these subjects received treatment with lanreotide Autogel and placebo, respectively, during the DB phase).

Lanreotide Autogel (Somatuline Depot) 120 mg (IOL Phase)

All 57 subjects in the LTOLE phase received further deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (32 and 25 of these subjects received treatment with lanreotide Autogel and placebo, respectively, during the DB phase).

Lanreotide Autogel (Somatuline Depot) 120 mg (LTOLE Phase)

Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase. Intent-to-treat (ITT) population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.

Lanreotide Autogel (Somatuline Depot) 120 mg

Total

Age, Continuous

Sex: Female, Male

Asian

Black/African American

White

Multi race

Race/Ethnicity, Customized

Intent-to-treat (ITT) population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.

Medical Director, Oncology

Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).

Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).

ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.

Percentage of Days With Subcutaneous Octreotide as Rescue Medication

Average Frequency of Diarrhoea Events (Per Day) Based on Subject Diary Records.

Average Frequency of Flushing Events (Per Day) Based on Subject Diary Records.

Percentage of Days of Use of Other Rescue Medication

Proportion of Subjects Who Rolled Over Into the IOL Phase Before Completing the DB Phase of the Study

ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.

Changes From Baseline in "Global Health Status/Quality of Life (QoL)" Score (Based on Items 29 and 30 of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire [EORTC-QLQ] C30)

Changes From Baseline in "Gastrointestinal (G.I). Symptoms" Subscore (Based on Items Q34, Q35, Q36, Q37 and Q38 of EORTC G.I. Neuroendocrine Tumour [NET] 21]

Changes From Baseline in QoL in "Endocrine Symptoms" Subscore (Assessed Based on Items Q31, Q32 and Q33 Using EORTC QLQ-G.I.NET-21 Questionnaires)

Absolute Changes From Baseline in Biochemical Markers (Plasma Chromogranin A [CgA])

Absolute Changes From Baseline in Biochemical Markers (Urinary 5-hydroxyindoleacetic Acid [5-HIAA])

Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the initial open label (IOL) phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the long term open label extension (LTOLE) phase.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Clinical Pharmacology of Platinum-based Hyperthermic Intraperitoneal Chemotherapy	NCT03364907	Peritoneal Carc...	HIPEC with flus... HIPEC without f...	18 Years -	Radboud University Medical Center
An Efficacy and Safety Study of Somatuline Depot (Lanreotide) Injection to Treat Carcinoid Syndrome	NCT00774930	Carcinoid Syndr...	Lanreotide Placebo	18 Years -	Ipsen

Spots Global Cancer Trial Database for flushing

Every month we try and update this database with for flushing cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for flushing

Every month we try and update this database with for flushing cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for flushing cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.