Neoplasms

Digestive System Diseases

All Conditions

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

For all the patients include in the study :

- Blood samples collected at different times : Before treatment, during treatment (approximately every other month) through the end of treatment

In parallel to this biological collection, standardized clinical data will be entered into a database

- Blood samples collected at different times : Before treatment, during treatment (approximately every other month) through the end of treatment

Biological collection

Jean-Pierre Bleuse, MD

Thibault Mazard, MD

Creation of a collection of blood samples that will be collected before and then under treatment in patients with digestive adenocarcinoma during the 1st and 2nd metastatic line and which, depending on scientific progress, can be used for research projects aimed at developing tailored patient management strategies.

Digestive cancers account for 30% of all cancers. The most common of these colorectal cancer (CRC) is the third most common cause of cancer in the world.

In the metastatic phase, patients with digestive cancers generally benefit from medical treatment based on cytotoxic chemotherapy, which can be combined with targeted therapy in certain locations. Their use is based on demonstrating a significant improvement in the overall survival of patients.

However, the therapeutic choice and follow-up of these treatments as a the first line treatment and beyond remain difficult given a cruel lack of biomarkers capable of predicting the response to these different molecules upstream but also usable during treatment to evaluate their efficacy or identify the development of secondary resistance mechanisms.

Indeed, the only biomarkers currently validated and used before the initiation of anti-cancer treatment to stratify patients are:

* the search for mutations in Kirsten rat sarcoma viral oncogene homolog (KRAS) and neuroblastoma rat sarcoma viral oncogene (NRAS) oncogenes as predictive factors for non-response to anti-Epidermal Growth Factor receptor (EGFR) in colorectal adenocarcinomas.
* the search for overexpression of the human epidermal growth factor (HER2) receptor to introduce trastuzumab treatment in esophageal adenocarcinomas.

In addition, they are conventionally determined from tumor tissue, which requires an invasive biopsy or surgical sampling that is difficult to repeat over time.

In this context, it seems essential to us to identify new parameters allowing a better personalization of anti-cancer treatments, by favouring blood biomarkers that have the advantage of being evaluated in a minimally invasive manner and therefore be repeated to be able to judge tumor dynamics.

To this end, we propose the creation of a collection of samples that will be collected before and then under treatment in patients with digestive adenocarcinoma in the 1st and 2nd metastatic line and which, depending on scientific progress, can be used for research projects aimed at developing tailored patient management strategies.

A Clinicobiological Database in Metastatic Digestive Cancers

Development of a Prospective Clinicobiological Database in Metastatic Digestive Cancers

Institut du Cancer de Montpellier - Val d'Aurelle

Rare Diseases

Rectal Neoplasms

Stomach Neoplasms

Intestinal Neoplasms

Stomach Diseases

Colorectal Neoplasms

Intestinal Diseases

Rectal Diseases

Stomach Cancer

Glycerol

endoscopic sub mucosal dissection of oesophagus stomach intestine or rectum lesions

endoscopic sub-mucosal dissection

PINSET CHRISTIAN, CEO

safety evaluation of endoscopic sub-mucosal dissection with nestis enki2 system. This system is a new water jet system which allows to perform Endoscopic submucosal dissection with a bifunctional catheter (injection and cutting).

Evaluation of the ability of this system to have a complete resection of superficial tumors of the digestive tract (that is to say a resection with free lateral and deep margins without residual tumor tissue)

Evaluation of the ability of such system to inject a viscous macromolecular solution of glycerol (glycerol mix: Glycerol 10 %, Fructose 5 %, saline solution 0.9%)(27. Fujishiro M, Yahagi N, Kashimura K, et al. Comparison of various submucosal injection solutions for maintaining mucosal elevation during endoscopic mucosal resection. Endoscopy. 2004;36:579-583.)

Multicentric Study an Endoscopic Treatment of Digestive Neoplasia by Submucosal Dissection Evaluation of a New Water Jet System

TRESTIS: Multicentric Study With a Curative Endoscopic Treatment of Superficial Neoplasia of a Digestive Tract by Endoscopic Submucosal Dissection: Evaluation of a New Water Jet System Injecting Glycerol Mix

inclusion duration is about 6 months the following period will be about 12 months so a total duration of 18 months

Hôpital Edouard Herriot

Thieery Ponchon

Carcinoma

Carcinoma, Squamous Cell

Adenocarcinoma

Esophageal Neoplasms

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

Micronutrients

Antineoplastic Agents

Hematinics

Vitamins

Leucovorin

Fluorouracil

Immunomodulating Agents

Durvalumab

Oxaliplatin

Levoleucovorin

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Antineoplastic Agents, Immunological

Folinic Acid

Folate

Vitamin B9

Concomitant administration of durvalumab (dose: 1500 mg):

Every 4 weeks during concurrent FOLFOX and after FOLFOX completion (total of 12 months of treatment)

Definitive modulated-intensity radiotherapy will be delivered according to boost integrated technique 5 days a week for 5 weeks at a dose of:

* 50 Gy delivered in 25 fractions to the macroscopic disease (endoscopic, TDM and fused FDG PET)
* 45 Gy to the adjacent peri tumoral mucosis and prophylactic lymph node

FOLFOX 4 simplified protocol, 1 infusion every 2 weeks during 3 months starting with radiotherapy (+/- 1 day):

* IV oxaliplatin 85 mg/m² in 2 h on D1
* IV Leucovorin 200 mg/m² in 2 h on D1, followed by
* IV 5-FU 400 mg/m² in 10 minutes on D1 followed by
* IV continuous infusion 5-FU 2400 mg/m² in 46 h

Definitive modulated-intensity radiotherapy will be delivered according to boost integrated technique 5 days a week for 5 weeks at a dose of:

* 50 Gy delivered in 25 fractions to the macroscopic disease (endoscopic, TDM and fused FDG PET)
* 45 Gy to the adjacent peri tumoral mucosis and prophylactic lymph node

FOLFOX 4 simplified protocol, 1 infusion every 2 weeks during 3 months starting with radiotherapy (+/- 1 day):

* IV oxaliplatin 85 mg/m² in 2 h on D1
* IV Leucovorin 200 mg/m² in 2 h on D1, followed by
* IV 5-FU 400 mg/m² in 10 minutes on D1 followed by
* IV continuous infusion 5-FU 2400 mg/m² in 46 h

Radiochemotherapy in standard arm and in experimental arm: 10 weeks (RT 50 Gy and FOLFOX q2w) Immunotherapy in experimental arm only: Patients will received concomitantly a maximum of 12 infusions

Radiochemotherapy in standard arm and in experimental arm: 10 weeks (RT 50 Gy and FOLFOX q2w)

IMRT 50 Gy + FOLFOX4 simplifIed (oxaliplatin, leucovorin, 5-FU)

Veronica Pezzella

Laure Monard

Farid EL HAJBI

Laurent Quero

Véronique VENDRELY-BUTTIAUX

David TOUGERON

Meher BEN ABDELGHANI

Anouchka Modesto

Rosine Guimbaud

Anouchka Modesto, Doctor

Laurent Quero, Doctor

This study aims to assess the efficacy of durvalumab in combination with radiochemotherapy (FOLFOX and IMRT) and then as maintenance therapy for treating patients with localised unresectable oesophageal cancer. This is a randomized, French national, multicentre, comparative phase II trial

ARION study will randomize 120 patients, in 12 centers in France, according to a ratio 1:1 in the following arm of treatment:

- Standard and experimental arm:

Definitive modulated-intensity radiotherapy will be delivered according to boost integrated technique 5 days a week for 5 weeks at a dose of:

* 50 Gy delivered in 25 fractions to the macroscopic disease (endoscopic, TDM and fused FDG PET)
* 45 Gy to the adjacent peri tumoral mucosis and prophylactic lymph node

FOLFOX 4 simplified protocol, 1 infusion every 2 weeks (q2w) during 3 months starting with radiotherapy (+/- 1 day):

* IV oxaliplatin 85 mg/m² in 2 h on day 1 (D1)
* IV Leucovorin 200 mg/m² in 2 h on D1, followed by
* IV 5-FU 400 mg/m² in 10 minutes on D1 followed by
* IV continuous infusion 5-FU 2400 mg/m² in 46 h
* Experimental arm: Concomitant administration of durvalumab:

Every 4 weeks during concurrent FOLFOX (dose: 1500 mg) and after FOLFOX completion (total of 12 months of treatment).

Association of Radiochemotherapy and Immunotherapy for the Treatment of Unresectable Oesophageal caNcer

Association of Radiochemotherapy and Immunotherapy for the Treatment of Unresectable Oesophageal caNcer: a Comparative Randomized Phase II Trial

Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

defined by a blinded independent centralized revue of progression free survival. cPFS is defined as the time from randomization until progression or death; patients alive and without documented progression at last follow-up news have PFS censored at this date or at initiation of new anticancer treatment (if applicable). Progression will be defined with central external reviewing of TDM per RECIST v1.1

defined as the time between randomization and death due to any cause.

will be assessed on occurrence of Adverse Events (AEs) based on NCI CTCAE v5.0

UNICANCER

Carcinoma, Signet Ring Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Cystic, Mucinous, and Serous

Diffuse Gastric Cancer

christophe mariette, MD, PhD

Background • A major increase in incidence of signet ring cell adenocarcinomas (ADCI) of the upper digestive tract in western countries

* Discordant results in the literature concerning the prognosis value of the presence of signet ring cells.
* Preliminary data suggesting (i) an advanced stage at time of diagnosis, (ii) more often in the form of carcinose, (iii) a more pejorative prognosis, (iv) a recurrence more frequent, more quickly, and more often in the form of peritoneal carcinose, (v) a chemo resistance (vi) the need for a specific therapeutic strategy compared to non-signet ring cell adenocarcinomas.

Primary objective To test the hypothesis that 5-year survival rate is significantly lower in the signet ring cells (SRC) adenocarcinoma when compared to non-SRC adenocarcinoma in the upper digestive tract

Secondary objectives

* Impact of neoadjuvant CT on overall survival
* Impact and differential diagnostic value of linitis
* R0 resection rates
* 3 years recurrence free survival
* Overall 3 years survival
* Prognostic factors
* Prognostic value of the presence of a minority quota of signet ring cell
* Objective response rate after medical treatment (chemotherapy, radiochemotherapy) in non-resected patients
* Tolerance of (radio) chemotherapy for ADCI

Methodology Intention to treat retrospective case-control multicentric study A pairing on demographic criteria (age, sex, ASA score, center) and tumor criteria (TNM stage) will be done to ensure comparability in case control study groups.

Inclusion criteria All consecutive patients taken care of, for a proven histologically adenocarcinoma (ADCI and ADNCI) of the esophagus, the esogastric junction, or the stomach, in surgical or medical oncology investigator centers, will be saved in a given database.

For whom the first consultation took place between January 1997 and January 2010

Exclusion criteria Histological type other than adenocarcinoma Other localization than esogastric junction, esophagus or stomach

Planned study period The data will be collected over a period from January 1997 to January 2010.

The objective is to complete the data collection for summer 2010.

stomach cancer signet ring cell carcinoma prognosis chemotherapy

Prognosis of Signet Ring Cells in Upper Digestive Neoplasms

Has the Quota of Signet Ring Cells an Influence on Prognosis and Treatment Strategy in the Upper GI Tract Adenocarcinomas?

University Hospital, Lille

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Clinicobiological Database in Metastatic Digestive Cancers	NCT03978078	Digestive Syste...	Biological coll...	18 Years -	Institut du Cancer de Montpellier - Val d'Aurelle
Multicentric Study an Endoscopic Treatment of Digestive Neoplasia by Submucosal Dissection Evaluation of a New Water Jet System	NCT01910974	Stomach Neoplas... Intestinal Neop... Rectal Neoplasm	endoscopic sub-...	18 Years - 90 Years	Hôpital Edouard Herriot
Association of Radiochemotherapy and Immunotherapy for the Treatment of Unresectable Oesophageal caNcer	NCT03777813	Esophagus Cance... Unresectable Ma...	Durvalumab IMRT 50 Gy + FO...	18 Years -	UNICANCER
Prognosis of Signet Ring Cells in Upper Digestive Neoplasms	NCT01249859	Signet Ring Cel... Stomach Disease Oesophagus Prognostic Case-control St...		18 Years - 95 Years	University Hospital, Lille

Spots Global Cancer Trial Database for oesophagus

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

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