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

Primary Purpose

Esophageal Neoplasms, Stomach Neoplasms

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Docetaxel, Oxaliplatin

Radiotherapy

About this trial

This is an interventional treatment trial for Esophageal Neoplasms focused on measuring chemoradiation, docetaxel, oxaliplatin, gastric, neoadjuvant, radiochemotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Johannes-Gutenberg-Universität

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

one arm

Arm Description

Outcomes

Primary Outcome Measures

maximum tolerable dose and safety

Secondary Outcome Measures

Full Information

NCT ID

NCT00374985

First Posted

September 11, 2006

Last Updated

November 27, 2014

Sponsor

Johannes Gutenberg University Mainz

1. Study Identification

Unique Protocol Identification Number

NCT00374985

Brief Title

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

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

October 2005 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Johannes Gutenberg University Mainz

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Neoplasms, Stomach Neoplasms

Keywords

chemoradiation, docetaxel, oxaliplatin, gastric, neoadjuvant, radiochemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

one arm

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Docetaxel, Oxaliplatin

Intervention Description

weekly doses

Intervention Type

Procedure

Intervention Name(s)

Radiotherapy

Intervention Description

regular fractions

Primary Outcome Measure Information:

Title

maximum tolerable dose and safety

Time Frame

until August 2010

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Markus Moehler, MD

Organizational Affiliation

Johannes Gutenberg University Mainz

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johannes-Gutenberg-Universität

City

Mainz

State/Province

Rheinland-Pfalz

ZIP/Postal Code

55131

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

23394629

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.

Results Reference

derived

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

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