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NCT Number: NCT00374985

Safety and Efficacy of Neoadjuvant Radiochemotherapy in Adenocarcinoma of the Gastric-oesophageal Junction

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.

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Key information

Conditions

Esophageal Neoplasms Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Johannes-Gutenberg-Universität

Mainz, Rhineland-Palatinate, 55131, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

docetaxel, oxaliplatin

Drug

weekly doses

Radiotherapy

Procedure

regular fractions

Primary outcomes

  1. maximum tolerable dose and safety

    Time frame: until August 2010

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2013
Study completion
2013
First posted
Sep 12, 2006
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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