Neoplasms

Digestive System Diseases

All Conditions

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anticonvulsants

Central Nervous System Depressants

Psychotropic Drugs

Capecitabine

Valproic Acid

Antimetabolites

Enzyme Inhibitors

Neurotransmitter Agents

short course radiotherapy (SCRT) alone 25 Gy in 5 fractions over one week.

Valproic acid (V) + short course radiotherapy

capecitabine (C) + short course radiotherapy

valproic acid + capecitabine + short course radiotherapy

preoperative radiation therapy

Antonio Avallone, M.D.

Maria Carmela Piccirillo, M.D.

The purpose of this study is to first determine the maximum tolerated dose of capecitabine given alone or in combination with valproic acid during preoperative short-course radiotherapy (Phase 1). The next part of the study (Phase 2)will explore whether the addition of valproic acid or the addition of capecitabine to short-course radiotherapy, before optimal radical surgery might increase the pathologic complete tumor regression rate in patients with low-moderate risk rectal cancer.

Preoperative Valproic Acid and Radiation Therapy for Rectal Cancer

Phase 1/2 Study of Valproic Acid and Short-course Radiotherapy Plus Capecitabine as preoperatIve Treatment in Low-moderate Risk Rectal Cancer

description of predictive role of early tumor metabolic changes measured by PET scan

evaluated at definitive surgery, planned 8 weeks after the end of radiotherapy, in all the study arms of Phase 2

National Cancer Institute, Naples

Colonic Diseases

1. st sub-grouup : Low risk to develop a CRC
2. nd sub-group : Moderate risk to develop a CRC
3. rd sub-group : High risk to develop a CRC

* remote support in physical activity and nutrition via digital media
* monthly collective physical activity sessions
* logbook

Low risk

* remote support in physical activity and nutrition via digital media
* monthly collective physical activity sessions
* one collective health education session
* logbook

Moderate risk

* remote support in physical activity and nutrition via digital media
* monthly collective physical activity sessions
* one collective health education session
* 3 individual sessions of motivational coaching
* connected watch
* logbook

High risk

Anne CATTEY-JAVOUHEY, MD, PhD

It has been estimated that 19,000 Colorectal Cancers (CRC) could be prevented each year in France by changing individual risk behaviours (sedentary lifestyle, overweight, diet, alcohol). The cancer screening appears to be an opportune moment for health promotion and to inform about CRC risk factors.

The PRECÔTION study proposes an innovative scheme based on informative, motivational and community-based approaches. The objectives are to take advantage of patients' visits for colonoscopy to raise awareness and initiate individual prevention actions according to their own risk in order to modify individual risk behaviour.

Patients who come for a colonoscopy at the Centre Léon Bérard and who are negative (80% of cases) will benefit from an evaluation to identify their individual risk factors, determine their level of risk level for CRC and their motivation to change their behaviour.

Participants with a low level of risk will receive remote support in physical activity and nutrition via digital media based on a motivational approach. Participants will be proposed a monthly collective physical activity session, which will allow them to interact with each other and develop a community approach. Participants with an intermediate level of risk will be offered a collective health education session, in addition to the the support offered to participants with a low level of risk. Participants with a high level of risk will receive, in addition to the the support offered to participants with an intermediate level of risk, an individual motivational coaching and a connected watch. A logbook will also be given to all participants to accompany them on the different tools, especially for monitoring their goals.

The PRECÔTION study aims to evaluate these tools as innovative means of prevention before evaluate their effectiveness on a larger scale.

Improve Colorectal Cancer Prevention by Motivational and Community-based Approaches

Pilot Study to Improve Primary Prevention of Colorectal Cancer by Motivational and Community-based Approaches, According to Individual Risk Level, in People Undergoing Colonoscopy

Participation rate at each modality of the programme

Participation rate to the study (number of participants/number of eligible persons)

Satisfaction, assessed by a Likert scale on a self-administered questionnaire

Evaluate the observance to the whole programme, for each subgroup

World Cancer Research Fund international questionnaire Score : from 0 (worse score) to 7 (better score)

Evaluate the effects on physical activity level using the IPAQ

Self-administered questionnaire (questionnaire specially designed for the study, no titlle) Score : from 0 (worse score) to 9 (better score)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Preoperative Valproic Acid and Radiation Therapy for Rectal Cancer	NCT01898104	Colorectal Canc...	preoperative ra... Valproic Acid Capecitabine	18 Years - 70 Years	National Cancer Institute, Naples
Improve Colorectal Cancer Prevention by Motivational and Community-based Approaches	NCT05568667	Colorectal Canc...	Low risk Moderate risk High risk	18 Years - 80 Years	Centre Leon Berard
Improve Colorectal Cancer Prevention by Motivational and Community-based Approaches	NCT05568667	Colorectal Canc...	Low risk Moderate risk High risk	18 Years - 80 Years	Centre Leon Berard
Preoperative Valproic Acid and Radiation Therapy for Rectal Cancer	NCT01898104	Colorectal Canc...	preoperative ra... Valproic Acid Capecitabine	18 Years - 70 Years	National Cancer Institute, Naples

Spots Global Cancer Trial Database for moderate risk