Gastric CancerPhase 2NCT01160419
Multicenter Study to Perioperative Chemotherapy for Resectable Adenocarcinoma in Gastric Cancer
A Phase 2 study testing Docetaxel 50 mg/m2, 1-hour-Infusion, day 1, Oxaliplatin 85 mg/m², 2-hour-Infusion, day 1 and Folinic acid 200 mg/m², 1-2-hour-Infusion, day 1 in people with Gastric Cancer, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
The rationale of the NEO-FLOT-trial consists of an intensification of the neoadjuvant treatment. This strategy is based upon the clear advantage of perioperative treatment and the fact, that in former trials adjuvant treatment could only be given in half of the patients (Cunningham 2006, Boige 2007). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Docetaxel 50 mg/m2, 1-hour-Infusion, day 1, Oxaliplatin 85 mg/m², 2-hour-Infusion, day 1 and Folinic acid 200 mg/m², 1-2-hour-Infusion, day 1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2009to May 2014
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically Confirmed Adenocarcinoma of the Gastroesophageal Junction (AEG I-III) or Gastric Adenocarcinoma (every T, N+ or T3/T4, Nx, M0)
- Written Informed Consent
- Age ≥ 18 Years
- Expected operability
- ECOG ≤ 2
Who cannot join
- Adequate Hematological, Renal, Cardiac and Hepatic Function
- Effective Contraception
- Prior Chemotherapy or Radiotherapy of the Adenocarcinoma of the Gastroesophageal Junction (AEG I-III) or Gastric Adenocarcinoma
- Not Histologically Confirmed Primary Tumor
- Distant Metastasis, Local Relapse
- Known Hypersensitivity for 5-Fluorouracil, Leucovorin, Oxaliplatin or Docetaxel
Show all 15Show fewer
- Known Dihydropyrimidin-Dehydrogenase (DPD) - Deficiency
- Peripheral Polyneuropathy ≥ Grade II (NCI-CTCAE, Version 3.0)
- Myocardial Infarction in the last 3 Months, Cardiac Insufficiency Grade II-IV (NYHA)
- Severe Comorbidity or Acute Infections
- Pregnancy or Breast Feeding
- Insufficient Contraception
- Participation in another Clinical Trial (Simultaneously or 30 Days Prior to Enrollment)
- Malignancy <5 years (except: Carcinoma In Situ of the Cervix Uteri or Adequately Treated Basalioma of the Skin)
- Lack of Legal Capacity
Trial locations and contacts
1 site in 1 country.
About this study
The rationale of the NEO-FLOT-trial consists of an intensification of the neoadjuvant treatment.
This strategy is based upon the clear advantage of perioperative treatment and the fact, that in former trials adjuvant treatment could only be given in half of the patients (Cunningham 2006, Boige 2007).
Read more
In this study neoadjuvant chemotherapy is applied during a period of 12 weeks with an interim staging after 6 weeks.Due to the favourable efficacy and toxicity data the FLOT-regimen was chosen for the neoadjuvant treatment consisting of oxaliplatin, docetaxel, folinic acid and 5-Fluorouracil (Al-Batran 2008).
Postoperative treatment according to the results of the MAGIC trail is not part of the trail and is given at the responsibility of the participating centres.
- Conditions
- Gastric Cancer
- Being tested
- Docetaxel 50 mg/m2, 1-hour-Infusion, day 1, Oxaliplatin 85 mg/m², 2-hour-Infusion, day 1, Folinic acid 200 mg/m², 1-2-hour-Infusion, day 1, 5-FU 2600 mg/m², 24-hour-Infusion, day 1
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel 50 mg/m2, 1-hour-Infusion, day 1Drug
50 mg/m2, 1-hour-Infusion, day 1
Oxaliplatin 85 mg/m², 2-hour-Infusion, day 1Drug
85 mg/m², 2-hour-Infusion, day 1
Folinic acid 200 mg/m², 1-2-hour-Infusion, day 1Drug
200 mg/m², 1-2-hour-Infusion, day 1
5-FU 2600 mg/m², 24-hour-Infusion, day 1Drug
2600 mg/m², 24-hour-Infusion, day 1
| Study group | Role | What they receive |
|---|---|---|
| FLOT | Other | Docetaxel, Oxaliplatin, Folinic acid, 5-FU, q 2 weeks, application of 6 cycles Receives: Drug: Docetaxel 50 mg/m2, 1-hour-Infusion, day 1; Drug: Oxaliplatin 85 mg/m², 2-hour-Infusion, day 1; Drug: Folinic acid 200 mg/m², 1-2-hour-Infusion, day 1; Drug: 5-FU 2600 mg/m², 24-hour-Infusion, day 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of the R0-Resection rate
after 6 cycles of biweekly FLOT chemotherapy and operation.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study startDec 2009
- Primary completionMay 2011 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01160419
- Sponsor's protocol ID
- NEO-FLOT
- Other IDs
- EudraCT Nr.: 2008-007546-56
- Status last verified
- Dec 2009
- First submitted
- 22 Oct 2009
- Last updated
- 28 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study to Perioperative Chemotherapy for Resectable Adenocarcinoma in Gastric Cancer
- ClinicalTrials.gov ID
- NCT01160419
- Acronym / sponsor ID
- NEO-FLOT
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Dec 2009
- Primary completion
- May 2011 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 12 Jul 2010 (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 rationale of the NEO-FLOT-trial consists of an intensification of the neoadjuvant treatment.
This strategy is based upon the clear advantage of perioperative treatment and the fact, that in former trials adjuvant treatment could only be given in half of the patients (Cunningham 2006, Boige 2007).
In this study neoadjuvant chemotherapy is applied during a period of 12 weeks with an interim staging after 6 weeks.Due to the favourable efficacy and toxicity data the FLOT-regimen was chosen for the neoadjuvant treatment consisting of oxaliplatin, docetaxel, folinic acid and 5-Fluorouracil (Al-Batran 2008).
Postoperative treatment according to the results of the MAGIC trail is not part of the trail and is given at the responsibility of the participating centres.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FLOT | Other | Drug: Docetaxel 50 mg/m2, 1-hour-Infusion, day 1, Drug: Oxaliplatin 85 mg/m², 2-hour-Infusion, day 1, Drug: Folinic acid 200 mg/m², 1-2-hour-Infusion, day 1, Drug: 5-FU 2600 mg/m², 24-hour-Infusion, day 1Docetaxel, Oxaliplatin, Folinic acid, 5-FU, q 2 weeks, application of 6 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically Confirmed Adenocarcinoma of the Gastroesophageal Junction (AEG I-III) or Gastric Adenocarcinoma (every T, N+ or T3/T4, Nx, M0)
- Written Informed Consent
- Age ≥ 18 Years
- Expected operability
- ECOG ≤ 2
Key exclusion criteria (15 listed)
- Adequate Hematological, Renal, Cardiac and Hepatic Function
- Effective Contraception
- Prior Chemotherapy or Radiotherapy of the Adenocarcinoma of the Gastroesophageal Junction (AEG I-III) or Gastric Adenocarcinoma
- Not Histologically Confirmed Primary Tumor
- Distant Metastasis, Local Relapse
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 50 mg/m2, 1-hour-Infusion, day 150 mg/m2, 1-hour-Infusion, day 1 | Drug | FLOT |
| Oxaliplatin 85 mg/m², 2-hour-Infusion, day 185 mg/m², 2-hour-Infusion, day 1 | Drug | FLOT |
| Folinic acid 200 mg/m², 1-2-hour-Infusion, day 1200 mg/m², 1-2-hour-Infusion, day 1 | Drug | FLOT |
| 5-FU 2600 mg/m², 24-hour-Infusion, day 12600 mg/m², 24-hour-Infusion, day 1 | Drug | FLOT |
Primary outcome
Collection of the R0-Resection rate
Time frame: 12 weeks
after 6 cycles of biweekly FLOT chemotherapy and operation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel 50 mg/m2, 1-hour-Infusion, day 1, Oxaliplatin 85 mg/m², 2-hour-Infusion, day 1 and Folinic acid 200 mg/m², 1-2-hour-Infusion, day 1 in people with Gastric Cancer, run by Ludwig-Maximilians - University of Munich 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 5 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 28 Oct 2010. 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 phase mean?
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?
Results are not available in the source record.
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?
Collection of the R0-Resection rate (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2010.