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Multicenter Study to Perioperative Chemotherapy for Resectable Adenocarcinoma in Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
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
Sponsored by
Ludwig-Maximilians - University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

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

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

Sites / Locations

  • University of Munich, Klinikum Grosshadern

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

FLOT

Arm Description

Docetaxel, Oxaliplatin, Folinic acid, 5-FU, q 2 weeks, application of 6 cycles

Outcomes

Primary Outcome Measures

Collection of the R0-Resection rate
after 6 cycles of biweekly FLOT chemotherapy and operation.

Secondary Outcome Measures

Full Information

First Posted
October 22, 2009
Last Updated
October 27, 2010
Sponsor
Ludwig-Maximilians - University of Munich
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01160419
Brief Title
Multicenter Study to Perioperative Chemotherapy for Resectable Adenocarcinoma in Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
May 2011 (Anticipated)
Study Completion Date
May 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Ludwig-Maximilians - University of Munich
Collaborators
Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FLOT
Arm Type
Other
Arm Description
Docetaxel, Oxaliplatin, Folinic acid, 5-FU, q 2 weeks, application of 6 cycles
Intervention Type
Drug
Intervention Name(s)
Docetaxel 50 mg/m2, 1-hour-Infusion, day 1
Intervention Description
50 mg/m2, 1-hour-Infusion, day 1
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin 85 mg/m², 2-hour-Infusion, day 1
Intervention Description
85 mg/m², 2-hour-Infusion, day 1
Intervention Type
Drug
Intervention Name(s)
Folinic acid 200 mg/m², 1-2-hour-Infusion, day 1
Intervention Description
200 mg/m², 1-2-hour-Infusion, day 1
Intervention Type
Drug
Intervention Name(s)
5-FU 2600 mg/m², 24-hour-Infusion, day 1
Intervention Description
2600 mg/m², 24-hour-Infusion, day 1
Primary Outcome Measure Information:
Title
Collection of the R0-Resection rate
Description
after 6 cycles of biweekly FLOT chemotherapy and operation.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Munich, Klinikum Grosshadern
City
Munich
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Multicenter Study to Perioperative Chemotherapy for Resectable Adenocarcinoma in Gastric Cancer

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