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Colorectal Neoplasms, Hereditary Nonpolyposis

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Gastrointestinal Neoplasms

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All Drugs and Chemicals

Mesalamine

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Mesalamine (Mesalazine, Pentasa sachet, 5-ASA) 2 g once daily for 2 years.

Placebo for Mesalamine (Mesalazine, Pentasa sachet, 5-ASA) 2 g once daily for 2 years.

The IMP will be supplied as sachets with slow-releasing granules.

Placebo

Ann-Sofie Backman, MD PhD

Lone Sunde, MD PhD

Luigi Ricciardiello, MD PhD

Jan Lubinski, MD PhD

David Ljungman, MD PhD

Irene Stenfors, MD

Gustav Silander, MD PhD

Joakim Folkesson, MD PhD

Multicenter, multinational, randomized, 2-arm, double-blind, phase II clinical study with 2000mg mesalamine, or placebo for prevention of colorectal neoplasia in Lynch Syndrome patients during and following daily intake for 2 years.

This is a multicenter, multinational, randomized, 2-arm, double-blind, phase II clinical study with 2000mg mesalamine (5-ASA) or placebo in LS patients for a 2-year treatment. 260 tumor free carriers of a known genetic mutation in a major MMR gene (including patients in which the polyps are endoscopically removed) will be randomized 1:1 to receive 2000mg mesalamine or placebo. Patients will be identified through local or national registries and through collaboration with sites. Tumor free patients, assessed by white light high resolution colonoscopy, will be randomized to the study. Blood and stool samples will be collected for analysis of microbiota, ctDNA and potential biomarkers. Biopsies of the normal tissue of ascending colon and rectum will be taken at the first and the last colonoscopy.

The aim of the study is to investigate the effect of regular treatment with mesalamine (5-ASA) on the occurrence of any colorectal neoplasia, tumor multiplicity (the number of detected adenomas/carcinomas) and tumor progression in LS patients.

Tumor multiplicity and tumor progression (severity of the neoplastic lesions) will be investigated.

Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome

Occurrence of any colorectal neoplasia (both benign and malignant tumors) between groups is described by absolute frequencies and percentages.

The number of colorectal neoplasia (both benign and malignant tumors) per patient will be tested between groups by an analysis of variance, adjusting for country and history of cancer before randomization. In case of non-normally distributed residuals a suitable transformation to achieve normal distribution is considered. It will be tested whether 5-ASA (low- and high-dose together) reduces the number of any colorectal neoplasia (both benign and malignant tumors; tumor multiplicity) compared to placebo in LS patients at the end of treatment and end of study. Advanced adenomas are defined by a diameter above 1 cm villous or tubulo-villous histology or high grade dysplasia.

The tumor progress in 4 ordered stages will be tested between groups stratified for country and history of cancer before randomization.

It will be tested whether 5-ASA reduces tumor progression (compared 4 ordinal stages: no colorectal neoplasia / non-advanced adenoma / advanced adenoma / carcinoma) compared to placebo in LS patients at the end of treatment and end of study. Advanced adenomas are defined by a diameter above 1 cm villous or tubulo-villous histology or high grade dysplasia.

The dependence of treatment effects on history of colorectal cancer, sex and patients age will be assessed by modelling interactions between these factors and treatment in the corresponding regression models.

If differences between 5-ASA effects and placebo effects on the occurrence of colorectal neoplasia, tumor multiplicity or tumor progression depend on the history of colorectal cancer, sex and patients age will be investigated.

Safety data are described and compared between groups in an exploratory manner to determine the safety concerning 5-ASA in LS patient. Therefore significant findings/illnesses, reported after the start of the study and which meet the definition of an AE, will be recorded in the CRF.

Intention to treat set: This analysis set includes subjects who were randomized (and received at least one dose study drug). This analysis set will be chosen for safety assessment.

The Swedish Research Council

Ann-Sofie Backman

Consultant gastroenterology

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome	NCT04920149	Lynch Syndrome Colon Cancer Colon Neoplasm	Mesalamine Placebo	30 Years -	Karolinska University Hospital
Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome	NCT04920149	Lynch Syndrome Colon Cancer Colon Neoplasm	Mesalamine Placebo	30 Years -	Karolinska University Hospital

Spots Global Cancer Trial Database for mesalamine

Every month we try and update this database with for mesalamine 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 mesalamine

Every month we try and update this database with for mesalamine 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 mesalamine 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.