|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Johannes Gutenberg University Mainz |
|---|---|
| Information provided by: | Johannes Gutenberg University Mainz |
| ClinicalTrials.gov Identifier: | NCT00374985 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Neoplasms Stomach Neoplasms |
Drug: Docetaxel, Oxaliplatin Procedure: Radiotherapy |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Prospective, Open, Multicentre Phase I/II Study to Evaluate the Safety and Efficacy of a Neoadjuvant Radiochemotherapy With Docetaxel and Oxalipaltin in Patients With Adenocarcinoma of the Gastric-Oesophageal Junction |
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2005 |
| Estimated Study Completion Date: | December 2009 |
Radiotherapy starts on day 1 of chemotherapy after the application of Docetaxel and Oxaliplatin and will be administered in single doses of 1.8 Gy once daily and five times a week for 5 weeks.
In the sixth treatment week a boost of 3 further radiations with 1.8 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 mg/m2 Oxaliplatin 40 mg/m2 i.v., Level 2: Docetaxel: 20 mg/m2 Oxaliplatin 50 mg/m2 i.v., Level 3: Docetaxel: 25 mg/m2 Oxaliplatin 50 mg/m2 i.v.,
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).
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Markus Moehler, MD | +49 6131 170 | mmoehler@mail.uni-mainz.de |
| Germany, Rheinland-Pfalz | |
| Johannes-Gutenberg-Universität | Recruiting |
| Mainz, Rheinland-Pfalz, Germany, 55131 | |
| Contact: Markus Möhler, MD 0049 6131 17 5712 moehler@mail.uni-mainz.de | |
| Principal Investigator: Markus Möhler, MD | |
| Principal Investigator: | Markus Moehler, MD | Johannes Gutenberg University Mainz |
More Information
| Study ID Numbers: | GC-DOR-2004 |
| Study First Received: | September 11, 2006 |
| Last Updated: | May 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00374985 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
chemoradiation docetaxel oxaliplatin |
gastric neoadjuvant radiochemotherapy |
|
Digestive System Neoplasms Esophageal disorder Gastrointestinal Diseases Esophageal Neoplasms Stomach cancer Carcinoma Docetaxel Oxaliplatin Digestive System Diseases |
Stomach Diseases Stomach Neoplasms Head and Neck Neoplasms Gastrointestinal Neoplasms Esophageal Diseases Adenocarcinoma Esophageal neoplasm Neoplasms, Glandular and Epithelial |
|
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
