Browse
Submit Data
Databases
API
Help

Dataset Information

0 Views

0 Connections

0 Citations

0 Reanalyses

0 Downloads

Omics score: 0

A phase 2 study of temozolomide in patients affected by metastatic colonrectal cancer with hypermethylation of 06-methylguanine-dna-methyltransferase

ABSTRACT: Primary objectives: - To assess the activity (in terms of response rate according to RECIST 1.1 criteria) of temozolomide (TMZ) in patients with refractory metastatic colorectal cancer with hypermethylation of MGMT Primary endpoints: - Objective tumor response rate according to RECIST 1.1 criteria - Duration of response, as the time period from first documentation of response (complete or partial response) to the date of first occurrence of documented disease progression - Progression-free survival, defined as the time period from start of the treatment to the date of first occurrence of documented disease progression or death from any cause within 60 days from the last disease assessment or from cycle 1, day 1 - Overall survival, defined as the time period from enrollment to death from any cause.

DISEASE(S): Colorectal Neoplasms Malignant,Carcinoma Colonrettale,Metastatic Colonrectal Cancer

PROVIDER: 2531067 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

ACCESS DATA

Json Xml

Similar Datasets

Biopsies from advanced melanoma before and/or after treatment with nivolumab

Project description:Expression profiling of tumor samples obtained during CA209-038 (ClinicalTrials.gov Identifier: NCT01621490). The purpose of this study is to evaluate pharmacodynamic changes of nivolumab and nivolumab in combination with ipilimumab treatment on the biomarkers measured in the peripheral blood and tumor tissues of subjects with advanced melanoma (unresectable or advanced). Samples are rumor core needle biopsies obtained at trial enrolment (i.e. Screen) and/or at Cycle 1 Day 29 (i.e.Week 4) from Subjects With Advanced Melanoma (Unresectable or Metastatic) treated with nivolumab (BMS-936558,MDX-1106) 3 mg/kg solution intravenously every 2 weeks on Bristol-Myers Squibb clinical trial protocol CA209-038 Part 1 . Cohort 2 patients have progressed on anti-CTLA4 (ipilimumab) monoclonal antibody therapy. Values are from an interim lock of the trial data in July 2014. Best overall response (BOR) was defined using RECIST 1.1 criteria: tumor assessments between date of first dose and the date of first objectively documented progression, or the date of non-missing subsequent anti-cancer therapy (whichever occurs first) were used to derive BOR. MPCT is Maximum reduction in tumor size (index lesions only) up to first progression, and is the value typically shown on a waterfall plot.

2022-01-01 | E-MTAB-4030 | biostudies-arrayexpress

Rational Anti-EGFR therapy Selection for the first-line treatment of patients with metastatic KRAS/NRAS wild type colorectal cancer based on the use of molecular predictor miR-31-5p (RASmiR)

Project description:Primary objectives: • Progression-Free Survival (PFS) in patients with low verus high miR-31-5p expression: Compare the predictive value of miR-31-5p expression as measured progression free survival. PFS is defined as the time from the date of randomization to the date of the first objectively documented tumor progression as assessed according to RECIST 1.1 or death due to any cause. Subjects who die without a reported prior progression will be considered to have progressed on the date of their death. Subjects who did not progress or die will be censored on the date of their last tumor assessment. Subjects who started any subsequent anti-cancer therapy without a prior reported progression will be censored. Primary endpoints: PFS A vs PFS B (PFS A > PFS B with ≥ 25 %)

| 2538002 | ecrin-mdr-crc

A multicenter randomized phase 2 study to compare the efficacy and safety of avelumab versus standard second line treatment, in patients with metastatic colorectal cancer (MMR) after first line treatment progression.

Project description:Primary objectives: Compare between the two treatment arms (arm A: 2nd line chemotherapy, arm B: avelumab) progression-free survival by central review (RECIST 1.1 for Arm A and iRECIST for arm B) Primary endpoints: The primary endpoint is radiographic progression-free survival (PFS). The progression will be assessed by central review according to the criteria RECIST v1.1 in arm A and according to the criteria irRECIST in arm B.PFS is defined as the time between the date of randomization and the date of the first radiological progression or the date of death (for whatever reason). Patients living without radiological progression will be censured on the date of their latest x-ray.

| 2536396 | ecrin-mdr-crc

A Phase 2 Study of Oral Enzastaurin HCl in Patients with Metastatic Colorectal Cancer

Project description:Main objective :To estimate the 6-month (24 weeks) progression-free survival for patients with metastatic CRC who are treated with enzastaurin. Primary endpoints: Progression Free survival estimate at 6 months is the primary efficacy endpoint. Progression-free survival is defined as the time from the date of the first enzastaurin dose to the first date of documented progressive disease or death due to any cause, whichever occurs first. Progression-free survival will be censored at the date of the last assessment visit for patients who are still alive and who have not had documented progressive disease.

| 2516768 | ecrin-mdr-crc

Differential T-cell and monocyte responses in hepatocellular carcinoma treated with regorafenib plus nivolumab: an integrated clinical and biomarker analysis of the phase 2 RENOBATE trial

Project description:Regorafenib has anti-tumor activity in patients with unresectable hepatocellular carcinoma (uHCC) with potential immunomodulatory effects, suggesting that its combination with immune checkpoint inhibitor may have clinically meaningful benefits in patients with uHCC. The multicenter, single-arm, phase 2 RENOBATE trial tested regorafenib-nivolumab as front-line treatment for uHCC. Forty-two patients received nivolumab 480 mg every 4 weeks and regorafenib 80 mg daily (3-weeks-on/1-week-off schedule). The primary endpoint was the investigator-assessed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The secondary endpoints included safety, progression-free survival (PFS) and overall survival (OS). ORR per RECIST version 1.1 was 31.0%, meeting the primary endpoint. The most common adverse events were palmar-plantar erythrodysesthesia syndrome (38.1%), alopecia (26.2%) and skin rash (23.8%). Median PFS was 7.38 months. The 1-year OS rate was 80.5%, and the median OS was not reached. Exploratory single-cell RNA sequencing analyses of peripheral blood mononuclear cells showed that long-term responders exhibited T cell receptor repertoire diversification, enrichment of genes representing immunotherapy responsiveness in MKI67+ proliferating CD8+ T cells and a higher probability of M1-directed monocyte polarization. Our data support further clinical development of the regorafenib-nivolumab combination as front-line treatment for uHCC and provide preliminary insights on immune biomarkers of response. ClinicalTrials.gov identifier: NCT04310709 .

2023-12-31 | GSE243572 | GEO

Randomised comparative study of folfox6m plus SIR-Spheres microspheres versus folfox6m alone as first line treatment in patients with non-resectable liver metastases from primary colorectal carcinoma

Project description:Primary objectives: The primary outcome of this study is progression free survival. Primary endpoints: The primary outcome of this study is progression free survival.Progression-free survival (PFS) is defined as the time interval between randomisation and the date of tumour progression. Tumour progression in the liver is determined from serial CT scans. Diagnosis of tumour recurrence (progression of disease) should be made by using RECIST Criteria.The documented date of recurrence will be the date of confirmation of the recurrence. At the time of recurrence, the investigator should clearly indicate the site of tumour recurrence (hepatic or extra-hepatic).

| 2524708 | ecrin-mdr-crc

Intra-arterial hepatic beads loaded with irinotecan (Debiri) with concomitant chemotherapy with FOLFOX in patients with colorectal cancer with unresectable liver metastases: a phase II multicenter study

Project description:Primary objectives: Taux de survie sans progression à 9 mois selon RECIST 1.1. Primary endpoints: Le critère de jugement principal sera d’évaluer la proportion de patients vivants sans progression (le décès sera considéré comme une progression) à 9 mois après le début du traitement selon les critères RECIST V1.1, évalué par l’investigateur. Le temps de survie sans progression sera définit comme l’intervalle de temps entre la date d’inclusion et la date de progression ou le décès (quelle que soit la cause). Pour les patients vivants sans progression, on prendra l’intervalle de temps entre la date d’inclusion et la date de dernière évaluation morphologique.

| 2746723 | ecrin-mdr-crc

A trial testing TAS-102 therapy versus an alternative high-dose, intermittent scheduling for sunitinib in patients with metastatic colorectal carcinoma.

Project description:Primary objectives: The primary objective of this study is to improve progression free survival (PFS), of patients with metastatic colorectal carcinoma (mCRC) treated with high-dose sunitinib once every 2 weeks to 5 months, compared to the reported 2 months for TAS-102 monotherapy Primary endpoints: The primary objective of this study is to improve PFS of patients with stage IV colorectal carcinoma, who progressed on (or are intolerant to) 5-FU, oxaliplatin, irinotecan, anti-VEGF (and/or anti-EGFR) containing therapy, treated with high-dose sunitinib (once every 2 weeks) to 5 months, compared to 2 months for patients treated with TAS-102 monotherapy. Progression free survival is defined as the time from randomization to the date of the first documented tumor progression as determined by the investigator using RECIST 1.1 criteria or death due to any cause. PFS between patients included in the two different study arms will be compared.

| 2536629 | ecrin-mdr-crc

Sotorasib and Panitumumab Versus Investigator’s Choice for Subjects with KRAS p.G12C Mutation

Project description:Main Objective: •To compare progression free survival (PFS) in previously treated subjects with KRAS p.G12C mutated colorectal cancer (CRC) receiving sotorasib 240 mg once daily (QD) and panitumumab vs investigator’s choice (trifluridine and tipiracil or regorafenib), and sotorasib 960 mg QD and panitumumab vs investigator’s choice (trifluridine and tipiracil or regorafenib) Primary end point(s): •Progression Free Survival (PFS) – defined as time from randomization until disease progression or death from any cause, whichever occurs first, for all subjects. Progression will be assessed using, use Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per Blinded Independent Central Review (BICR)

| 2541579 | ecrin-mdr-crc

Locally Advanced Rectal Cancer - Radiation Response Prediction Study - Serum Proteins

Project description:The study objective was to find new biomarkers of treatment response and adverse events in patients receiving neoadjuvant therapy for locally advanced rectal cancer. Patients received neoadjuvant chemotherapy (NACT) followed by chemoradiotherapy (CRT) and underwent treatment evaluation four weeks after CRT completion. Radical pelvic surgery was planned 2-4 weeks later. Patients were scored for treatment adverse events, according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, throughout the neoadjuvant treatment course, including at NACT and CRT completion. Treatment response was assessed by histologic ypTN staging and tumor regression grade (TRG) scoring, as well as progression-free survival (time from Inclusion date to Date of local relapse or Date of metastatic disease, whichever came first) recorded for five years after surgery.

2016-04-21 | GSE65622 | GEO

OmicsDI is part of the ELIXIR infrastructure

OmicsDI is an Elixir interoperability service. Learn more ›

Tweets

OmicsDI Databases

PRIDE
PeptideAtlas
MassIVE
JPOST Repository
Physiome Model Repository

EGA
EVA
ENA
LINCS
PAXDB
Cell Collective

MetaboLights
Metabolomics Workbench
MetabolomeExpress
GNPS
BioModels
FAIRDOMHub

ArrayExpress
dbGaP
ExpressionAtlas
GEO
NODE

Information

Databases
Help
API
Contact us
Code on GitHub
Terms of use
Submit Data