Esophageal NeoplasmsPhase 1/2NCT00374985
Safety and Efficacy of Neoadjuvant Radiochemotherapy in Adenocarcinoma of the Gastric-oesophageal Junction
A Phase 1/2 study testing Docetaxel, Oxaliplatin and Radiotherapy in people with Esophageal Neoplasms and Stomach Neoplasms, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Neoplasms, Stomach Neoplasms
- What is being tested?
- Docetaxel, Oxaliplatin and Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2005to Sep 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adenocarcinoma of gastric-esophagal junction
- stage II to III
- unidimensional measurable disease
Who cannot join
- surgery of primary tumor
- metastasis
- prior chemo- or radiotherapy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Johannes-Gutenberg-Universität
Mainz, Rhineland-Palatinate, 55131
About this study
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
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.
Read the 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).
- Conditions
- Esophageal Neoplasms, Stomach Neoplasms
- Being tested
- Docetaxel, Oxaliplatin, Radiotherapy
- Keywords
- chemoradiation, docetaxel, oxaliplatin, gastric, neoadjuvant, radiochemotherapy
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel, OxaliplatinDrug
weekly doses
RadiotherapyProcedure or surgery
regular fractions
| Study group | Role | What they receive |
|---|---|---|
| one arm | Experimental | Not described Receives: Drug: Docetaxel, Oxaliplatin; Procedure: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum tolerable dose and safety
Measured: until August 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2006 (estimated)
- Study startOct 2005
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr Markus Möhler, Johannes Gutenberg University Mainz
- Investigators
- Markus Moehler, MD, Principal investigator, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00374985
- Sponsor's protocol ID
- GC-DOR-2004
- Status last verified
- Nov 2014
- First submitted
- 11 Sep 2006
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23394629
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00374985
- Acronym / sponsor ID
- GC-DOR-2004
- Conditions
- Esophageal Neoplasms, Stomach Neoplasms
- Keywords
- chemoradiation, docetaxel, oxaliplatin, gastric, neoadjuvant, radiochemotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 12 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one arm | Experimental | Drug: Docetaxel, Oxaliplatin, Procedure: Radiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adenocarcinoma of gastric-esophagal junction
- stage II to III
- unidimensional measurable disease
Key exclusion criteria (3 listed)
- surgery of primary tumor
- metastasis
- prior chemo- or radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docetaxel, Oxaliplatinweekly doses | Drug | one arm |
| Radiotherapyregular fractions | Procedure or surgery | one arm |
Primary outcome
maximum tolerable dose and safety
Time frame: until August 2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
- Derived from this study: PubMed 23394629Moehler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Moehler, MD principal investigator
Johannes Gutenberg University Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Docetaxel, Oxaliplatin and Radiotherapy in people with Esophageal Neoplasms and Stomach Neoplasms, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum tolerable dose and safety (time frame: until August 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00374985, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014.