Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Urinary Bladder Neoplasms

Genomic Instability

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Tumors from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine included in VESPER cohort

Tumors from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine included in Saint-Louis cohort

Tumors from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine included in COBLAnCE cohort

Blood from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine

neoadjuvant chemotherapy with cisplatine

Yves ALLORY, MD

This study will allow the investigators to better assess the efficiency of neoadjuvant chemotherapy before cystectomy by training a predictive model on different patient cohorts with bladder cancer.

The project is based on three prospective cohorts of patients with MIBC: the VESPER trial (n=296), the St-Louis Hospital cohort (n=99), and the COBLAnCE cohort (n=312). Using WES and RNAseq, the investigators will determine genomic instability, DDR gene mutation and molecular subtypes. After digitization of tumour slides, the investigators will train and test predictive models based on deep learning approaches to predict outcome after neoadjuvant chemotherapy, either by estimating molecular subtypes and genetic features from pathological images, or by directly defining a prognostic signature. The statistical analyses will assess the performance of the models combining genomic instability, DNA Damage Response mutations and/or molecular subtyping to predict outcome after neoadjuvant chemotherapy and compare them with the models based on WSI deep learning approaches. These results will help to design new therapeutic strategies.

Bladder Cancer and Neoadjuvant Chemotherapy Efficiency Before Cystectomy

Survival prEdiction in bLadder Cancer Patients Treated by nEoadjuvant Chemotherapy Before cysTectomy

The time from enrollment to progression or death

Institut Curie

University Hospital, Rouen

Digestive System Diseases

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Herbal and Botanical

Oxaliplatin

Leucovorin

Fluorouracil

Irinotecan

Capecitabine

Cola

12 weeks of FOLFOXIRI neuoadjuvantly followed by surgery and adjuvant chemotherapy

surgery followed by 24 weeks of FOLFOX or CapeOX or Cape

mFOLFOXIRI (IV oxaliplatin given over 120 min at a dose of 85 mg/m2 on day 1 followed by IV leucovorin 400 mg/m2 over 2h, IV Irinotecan 150 mg/m2 and IV infusional 5-Fluorouracil 2400 mg/m2 over 48h every 14 days) for 6 cycles followed by colectomy (3 to 6 weeks after) . If PD was observed after 3 cycles, direct colectomy was performed.

neoadjuvant chemotherapyI

Colectomy

mFOLFOX6 (IV oxaliplatin given over 120 min at a dose of 85 mg/m2 on day 1 followed by IV leucovorin 400 mg/m2 over 2h, IV bolus 5-Fluorouracil 400 mg/m2 and IV infusional 5-Fluorouracil 2400 mg/m2 over 46h every 14 days) . CAPOX (IV oxaliplatin given over 120 min at a dose of 130 mg/m2 on day 1, oral capecitabine 1000 mg/m2 twice daily on days 1 through 14 every 21 days) . Oral capecitabine 1000 mg/m2 twice daily on days 1 through 14 every 21 days. The plan and cycles are determined according to the surgical pathology and physical conditions.

adjuvant chemotherapy

Peirong Ding, Doctor

Yuan Li, Doctor

BACKGROUND:

In patients with high risk stage II and stage III colon cancer (CC), curative surgery followed by adjuvant chemotherapy with FOLFOX or CAPOX regimens has become a standard treatment. However, 20 to 30 % of these patients will develop distant metastasis, which ultimately result in death. Perioperative chemotherapy is a promising strategy with potential benefits that could be more effective at eradicating micrometastases. Moreover, shrinking tumor before surgery not only facilitate removal of all the tumor by the surgeon but also reduce tumor cell spreading during the procedure. With recent advances in radiology, preoperative computed tomography allows a good prediction of tumor stage (wall penetration and nodal involvement) prior to surgery. The investigators conducted the present randomized study to explore whether perioperative chemotherapy with FOLFOXIRI regimen compared with postoperative chemotherapy could improve disease-free survival in patients with radiologically staged, High-risk, but resectable Stage II or III colon cancer.

OBJECTIVE:

The primary objective of this study is to evaluate the efficacy of perioperative chemotherapy with FOLFOXIRI regimen compared to postoperative chemotherapy in patients with High-risk Resectable Stage II and III colon cancer. Secondary objectives are efficacy in terms of R0 resection rate, overall survival (OS), relapse-free survival (RFS), down-staging of primary tumors, and tolerability of perioperative therapy and postoperative complications.

This trial is a a two-arm, multicenter, open labelled, prospective, randomized phase III studies. Eligible patients with High-risk Resectable Stage II and III (T4 or T3 with extramural depth≧5 mm) colon cancer patients will be randomly assigned, in a 2:1 ratio, to receive either perioperative or postoperative chemotherapy.

Neoadjuvant FOLFOXIRI Versus Immediate Surgery for Stage II and III Colon Cancers

Phase III Study of Neoadjuvant FOLFOXIRI Chemotherapy Versus Immediate Surgery for High-risk Resectable Stage II and III Colon Cancers

Defined as the time from randomization to relapse or death, whichever occurred first

Defined as the time from randomization to death from any cause

Down-staging of the resected tumour as measured by histopathological tumour diameter and stage according to the TNM staging system of AJCC (7th version)

The grade of toxicity will be assessed using the NCI common toxicity criteria, version 4.0

CT evaluation of the thickness of tumor walls or tumor diameter or tumor length. Efficacy evaluation will be assessed using the RECIST criteria, version 1.1.

Sun Yat-sen University

Professor

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Adenocarcinoma

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Folfirinox

Participants in this trial will receive neoadjuvant and adjuvant FOLFIRINOX chemotherapy for 6 cycles (1 cycle = 14 days) per routine guidelines.

After 6 cycles of neoadjuvant therapy are completed, patients will undergo imaging with pancreatic protocol CT and PET-MRI to assess disease status . Patients without evidence of disease progression at the end of 6 cycles of neoadjuvant treatment will proceed to SBRT followed by surgical resection.

Following surgery, patients will receive an additional 6 cycles of FOLFIRINOX chemotherapy.

Patients will receive 5 fractions of SBRT delivered over a five-day period. Treatment may be delivered over 2 weeks, provided that the patient receives at least 2 fractions per week.

Stereotactic Body Radiation Therapy (SBRT)

Participants in this trial will receive neoadjuvant and adjuvant FOLFIRINOX chemotherapy for 6 cycles (1 cycle = 14 days) per routine guidelines

FOLFIRINOX

Susannah Ellsworth, MD

The purpose of this study is to research the effects of delivering full-dose neoadjuvant multi-agent chemotherapy (folfirinox) followed by stereotactic body radiation therapy (SBRT) in patients with resectable pancreatic ductal adenocarcinoma (PDAC) in order to intensify local therapy and improve outcomes.

Primary Objectives:

1. To assess one-year local control rates in patients with operable PDAC who receive neoadjuvant chemotherapy and SBRT

Secondary Objectives:

1. To assess the following disease control endpoints: pathological response, disease-free survival, overall survival, failure pattern (local vs. distant) and time to development of distant metastases
2. To assess safety of the SBRT regimen

Exploratory objectives

1. To obtain exploratory data correlating tumor response grade with changes in circulating tumor DNA levels following chemotherapy, SBRT, and surgery in patients with PDAC
2. To obtain exploratory data correlating circulating tumor DNA (ctDNA) changes with disease control endpoints (overall survival, disease-free survival, failure pattern, and time to development of distant metastases)
3. To obtain exploratory data on positron emission tomography (PET) and magnetic resonance imaging (MRI) findings and correlations with tumor response among patients treated on study.

preoperative chemotherapy with FOLFIRINOX followed by SBRT in patients with resectable pancreatic cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Bladder Cancer and Neoadjuvant Chemotherapy Efficiency Before Cystectomy	NCT06294054	Bladder Cancer Genomic Instabi...	neoadjuvant che...	18 Years - 80 Years	University Hospital, Rouen
Neoadjuvant FOLFOXIRI Versus Immediate Surgery for Stage II and III Colon Cancers	NCT05194878	Colon Cancer St... Colon Cancer St...	neoadjuvant che... Colectomy adjuvant chemot...	18 Years - 75 Years	Sun Yat-sen University
Study of Neoadjuvent Chemotherapy Followed by SBRT in Patients With Resectable and Borderline Resectable Pancreatic Cancer	NCT04130399	Pancreatic Canc... Pancreatic Aden...	Stereotactic Bo... FOLFIRINOX	18 Years -	Indiana University
Study of Neoadjuvent Chemotherapy Followed by SBRT in Patients With Resectable and Borderline Resectable Pancreatic Cancer	NCT04130399	Pancreatic Canc... Pancreatic Aden...	Stereotactic Bo... FOLFIRINOX	18 Years -	Indiana University

Spots Global Cancer Trial Database for neoadjuvent chemotherapy