Clinical trial NCT00374985: Safety and Efficacy of Neoadjuvant Radiochemotherapy in Adenocarcinoma of the Gastric-oesophageal Junction
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Esophageal Neoplasms
Stomach Neoplasms
Keywords: chemoradiation
docetaxel
oxaliplatin
gastric
neoadjuvant
radiochemotherapy
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2006-09-12
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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 criteria: Inclusion Criteria:

* adenocarcinoma of gastric-esophagal junction
* stage II to III
* unidimensional measurable disease

Exclusion Criteria:

* surgery of primary tumor
* metastasis
* prior chemo- or radiotherapy

Primary outcomes:
measure: maximum tolerable dose and safety
timeFrame: until August 2010
Secondary outcomes:
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Johannes-Gutenberg-Universität
state: Rheinland-Pfalz
Study officials:
affiliation: Johannes Gutenberg University Mainz
name: Markus Moehler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moehler M, Gockel I, Roessler HP, Arnold D, Trarbach T, Thomaidis T, Klautke G, Rodel C, Brenner B, Lang H, Galle PR, Schimanski CC, Schmidberger H. Prospective, open, multi-centre phase I/II trial to assess safety and efficacy of neoadjuvant radiochemotherapy with docetaxel and oxaliplatin in patients with adenocarcinoma of the oesophagogastric junction. BMC Cancer. 2013 Feb 11;13:75. doi: 10.1186/1471-2407-13-75.