Safety and Efficacy of Neoadjuvant Radiochemotherapy in Adenocarcinoma of the Gastric-Oesophageal Junction
Recruitment status was Recruiting
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.
Drug: Docetaxel, Oxaliplatin
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- maximum tolerable dose
- doselimiting toxicity
- response rate
- complications due to surgery and post-surgery
- ability for resection after radiochemotherapy
- rates of local recurrence and distant metastasis
- 1-year and 2-year survival
- toxicity of neoadjuvant radiochemotherapy
- Quality of Life
|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.
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).
|Contact: Markus Moehler, MD||+49 6131 firstname.lastname@example.org|
|Mainz, Rheinland-Pfalz, Germany, 55131|
|Contact: Markus Möhler, MD 0049 6131 17 5712 email@example.com|
|Principal Investigator: Markus Möhler, MD|
|Principal Investigator:||Markus Moehler, MD||Johannes Gutenberg University Mainz|