Ignite Creation Date:
2024-05-06 @ 2:19 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04281576
Status:
UNKNOWN
Last Update Posted:
2020-06-25
First Post:
2020-02-20
Brief Title:
Effect of Tumor Treating Fields TTFields 150 kHz Concomitant With Chemotherapy as First Line Treatment of Unresectable Gastroesophageal Junction or Gastric Adenocarcinoma
Sponsor:
NovoCure GmbH
Organization:
NovoCure Ltd
Study Overview
Official Title:
A Phase 2 Single Arm Multi-center Open-Label Trial to Evaluate the Safety and Efficacy of Treatment With Tumor Treating Fields TTFields and Chemotherapy as First-Line Treatment for Subjects With Unresectable Gastroesophageal Junction GEJ Adenocarcinoma or Gastric GC Adenocarcinoma
Status:
UNKNOWN
Status Verified Date:
2020-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is a prospective single arm phase II trial aimed to evaluate the efficacy and safety of Tumor Treating Fields TTFields concomitant with XELOX for the treatment of unresectable locally advanced or metastatic Gastroesophageal Junction GEJ or Gastric GC Adenocarcinoma who were previously untreated with systemic therapy The device is an experimental portable battery operated device for chronic administration of alternating electric fields termed TTFields or TTF to the region of the malignant tumor by means of surface insulated electrode arrays
Detailed Description:
PAST PRE-CLINICAL AND CLINICAL EXPERIENCE
The effect of the electric fields TTFields TTF has demonstrated significant activity in in vitro gastric cancer pre-clinical models both as a single modality treatment and in combination with chemotherapies In addition TTFields have shown to inhibit metastatic spread of malignant melanoma in in vivo experiment
Prospective multi-center clinical studies of TTFields have shown the safety of the treatment when administered to the abdomen for pancreatic cancer and ovarian cancer
In addition a phase III trial of Optune 200 kHz as monotherapy compared to active chemotherapy in recurrent glioblastoma patients showed TTFields to be equivalent to active chemotherapy in extending survival associated with minimal toxicity good quality of life and activity within the brain 14 response rate Finally a phase III trial of Optune combined with maintenance temozolomide compared to maintenance temozolomide alone has shown that combined therapy led to a significant improvement in both progression free survival and overall survival in patients with newly diagnosed glioblastoma without the addition of high grade toxicity and without decline in quality of life
DESCRIPTION OF THE TRIAL
All patients included in this trial are patients with unresectable Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma In addition all patients must meet all eligibility criteria
All eligible patients will receive continuous Tumor Treating Fields TTFields - NovoTTF-100L P treatment at 150 KHz frequency and XELOX regimen combination of oxaliplatin capecitabine Patients will be assessed once every 9 weeks according to RECIST v11 Study treatment should be continued until disease progression intolerable toxicity or withdrawal of informed consent
The effect of the electric fields TTFields TTF has demonstrated significant activity in in vitro gastric cancer pre-clinical models both as a single modality treatment and in combination with chemotherapies In addition TTFields have shown to inhibit metastatic spread of malignant melanoma in in vivo experiment
Prospective multi-center clinical studies of TTFields have shown the safety of the treatment when administered to the abdomen for pancreatic cancer and ovarian cancer
In addition a phase III trial of Optune 200 kHz as monotherapy compared to active chemotherapy in recurrent glioblastoma patients showed TTFields to be equivalent to active chemotherapy in extending survival associated with minimal toxicity good quality of life and activity within the brain 14 response rate Finally a phase III trial of Optune combined with maintenance temozolomide compared to maintenance temozolomide alone has shown that combined therapy led to a significant improvement in both progression free survival and overall survival in patients with newly diagnosed glioblastoma without the addition of high grade toxicity and without decline in quality of life
DESCRIPTION OF THE TRIAL
All patients included in this trial are patients with unresectable Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma In addition all patients must meet all eligibility criteria
All eligible patients will receive continuous Tumor Treating Fields TTFields - NovoTTF-100L P treatment at 150 KHz frequency and XELOX regimen combination of oxaliplatin capecitabine Patients will be assessed once every 9 weeks according to RECIST v11 Study treatment should be continued until disease progression intolerable toxicity or withdrawal of informed consent
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None