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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


Phase 1/Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Esophageal Neoplasms, Stomach Neoplasms

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Trial Information

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


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).


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

maximum tolerable dose

Principal Investigator

Markus Moehler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johannes Gutenberg University Mainz

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

GC-DOR-2004

NCT ID:

NCT00374985

Start Date:

October 2005

Completion Date:

December 2009

Related Keywords:

  • Esophageal Neoplasms
  • Stomach Neoplasms
  • chemoradiation
  • docetaxel
  • oxaliplatin
  • gastric
  • neoadjuvant
  • radiochemotherapy
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms

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