Multicenter Study to Perioperative Chemotherapy for Resec... | NCT01160419

Studies
Multicenter Study to Perioperative Chemotherapy for Resectable Adenocarcinoma in Gastric Cancer

NCT01160419

Sponsor

Ludwig-Maximilians - University of Munich

Status

Unknown status

Last Update Posted

Oct 28, 2010Estimated

Enrollment

49Estimated

Phase

Phase 2

Conditions

Gastric Cancer

Interventions

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

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
EudraCT Nr.: 2008-007546-56

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

May 2011Estimated

Completion Date

May 2014Estimated

First Submitted Date

Oct 22, 2009

First Submission Date that Met QC Criteria

Jul 9, 2010

First Posted Date

Jul 12, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 27, 2010

Last Update Posted Date

Oct 28, 2010Estimated

Name	Class
Sanofi	INDUSTRY

Description Module

Brief 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).

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

49Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FLOT	Other	Docetaxel, Oxaliplatin, Folinic acid, 5-FU, q 2 weeks, application of 6 cycles	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Docetaxel 50 mg/m2, 1-hour-Infusion, day 1	Drug	50 mg/m2, 1-hour-Infusion, day 1	FLOT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Collection of the R0-Resection rate	after 6 cycles of biweekly FLOT chemotherapy and operation.	12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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
Exclusion of Peritoneal Metastasis
Adequate Hematological, Renal, Cardiac and Hepatic Function
Effective Contraception

Exclusion Criteria:

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
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D013274	Stomach Neoplasms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D013272	Stomach Diseases

ID	Term
D000077143	Docetaxel
D000077150	Oxaliplatin
D002955	Leucovorin
D005472	Fluorouracil

Ancestor Terms

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D056831	Coordination Complexes
D005575	Formyltetrahydrofolates
D013763	Tetrahydrofolates
D005492	Folic Acid
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D003067	Coenzymes
D045762	Enzymes and Coenzymes
D014498	Uracil
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring