Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00374985
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2006-09-11
Brief Title:
Safety and Efficacy of Neoadjuvant Radiochemotherapy in Adenocarcinoma of the Gastric-oesophageal Junction
Sponsor:
Johannes Gutenberg University Mainz
Organization:
Johannes Gutenberg University Mainz
Study Overview
Official Title:
Prospective Open Multicentre Phase III Study to Evaluate the Safety and Efficacy of a Neoadjuvant Radiochemotherapy With Docetaxel and Oxalipaltin in Patients With Adenocarcinoma of the Gastric-oesophageal Junction
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
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 purpose of this study is to determine the dose limiting toxicity and the maximum tolerable dose of the radiochemotherapy with Docetaxel and Oxaliplatin in patients with adenocarcinoma of the gastric-oesophageal junction
Detailed Description:
Radiotherapy starts on day 1 of chemotherapy after the application of Docetaxel and Oxaliplatin and will be administered in single doses of 18 Gy once daily and five times a week for 5 weeks
In the sixth treatment week a boost of 3 further radiations with 18 Gy will be applied
Simultaneous chemotherapy
Initially in part A of the study the maximum tolerable dose MTD for the simultaneous chemotherapy will be identified with a 3-step dose escalation scheme
Level 1 Docetaxel 20 mgm2 Oxaliplatin 40 mgm2 iv Level 2 Docetaxel 20 mgm2 Oxaliplatin 50 mgm2 iv Level 3 Docetaxel 25 mgm2 Oxaliplatin 50 mgm2 iv
The treatment starts with 3 patients in level 1 If no dose limiting toxicities appear it will be switched to dose level 2 The same applies for the switch from level 2 to level 3 If a DLT appears on one level a further 3 patients will be treated within this dose level
If in one level at least 2 of 6 patients show DLT the subjacent level will be defined as the maximum tolerable dose MTD
In the sixth treatment week a boost of 3 further radiations with 18 Gy will be applied
Simultaneous chemotherapy
Initially in part A of the study the maximum tolerable dose MTD for the simultaneous chemotherapy will be identified with a 3-step dose escalation scheme
Level 1 Docetaxel 20 mgm2 Oxaliplatin 40 mgm2 iv Level 2 Docetaxel 20 mgm2 Oxaliplatin 50 mgm2 iv Level 3 Docetaxel 25 mgm2 Oxaliplatin 50 mgm2 iv
The treatment starts with 3 patients in level 1 If no dose limiting toxicities appear it will be switched to dose level 2 The same applies for the switch from level 2 to level 3 If a DLT appears on one level a further 3 patients will be treated within this dose level
If in one level at least 2 of 6 patients show DLT the subjacent level will be defined as the maximum tolerable dose MTD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None