Prospective Study With FLOT in Patients With Locally Advanced, Limited Metastatic or Extensive Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction

NCT00849615 | Completed Phase 2 DMC

• 1 other identifier: S396 FLOT3
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with locally advanced or metastatic gastric carcinoma or carcinoma of the esophagogastric junction without prior palliative therapy will be treated with 8 cycles of the FLOT scheme (up to 12 cycles if the response is favourable). Prior to enrollment a unique and detailed clinical evaluation of the dissemination of the disease will be done which includes a differentiated regard of the metastatic status. patients will be classified as having either (A) locally advanced, (B) limited metastatic, or (C) extensive metastatic disease. In arms A and B surgical intervention is planned if operability is reached. The hypothesis is that by classifying patients more individually by the state of their disease, patients in arm B will have a significantly prolonged overall survival compared to patients in arm C.

Conditions

Gastric Cancer; Adenocarcinoma of the Esophagogastric Junction

Outcome Measures

Primary Outcomes (1)

• overall survival

  every 2 weeks during study, every 3 months follow-up

Secondary Outcomes (4)

• Pharmacogenetic risk profile

  once at beginning

• Quality of Life

  every 8 weeks

• Progression free survival (PFS) and response rate (Stratum B and C)

  every 8 weeks

• rate of R0-resections, rate of pathological remissions and perioperative morbidity and mortality in stratum A and B Perioperative Morbidität und Mortalität in dem Arm A und ggf. B

  after surgical intervention

Study Arms (1)

FLOT

EXPERIMENTAL

Drug: Docetaxel; Drug: 5-Fluorouracil; Drug: Oxaliplatin; Drug: folinic acid

Interventions

Docetaxel DRUG

50mg/m2 qd15

FLOT

5-Fluorouracil DRUG

2600mg/m2 qd15

FLOT

Oxaliplatin DRUG

85mg/m2 qd15

FLOT

folinic acid DRUG

200mg/m2 qd15

FLOT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Metastatic or locally advanced gastric cancer or adenocarcinoma of the esophagogastric junction
• No prior chemotherapy in metastatic state
• Adequate blood and biochemistry parameters

You may not qualify if:

• Hypersensitivity for 5-FU, Leucovorin, Oxaliplatin or Docetaxel
• KHK, cardiomyopathy or cardiac insufficiency
• Malignancy \<5 years ago
• Brain metastases
• Severe internal disease or inadequate blood and biochemistry parameters
• Pregnancy and lactation

Sponsors & Collaborators

• Krankenhaus Nordwest: lead

Study Sites (1)

Krankenhaus Nordwest

Frankfurt, 60488, Germany

Location

Related Publications (4)

• Al-Batran SE, Hartmann JT, Probst S, Schmalenberg H, Hollerbach S, Hofheinz R, Rethwisch V, Seipelt G, Homann N, Wilhelm G, Schuch G, Stoehlmacher J, Derigs HG, Hegewisch-Becker S, Grossmann J, Pauligk C, Atmaca A, Bokemeyer C, Knuth A, Jager E; Arbeitsgemeinschaft Internistische Onkologie. Phase III trial in metastatic gastroesophageal adenocarcinoma with fluorouracil, leucovorin plus either oxaliplatin or cisplatin: a study of the Arbeitsgemeinschaft Internistische Onkologie. J Clin Oncol. 2008 Mar 20;26(9):1435-42. doi: 10.1200/JCO.2007.13.9378.

  PMID: 18349393 BACKGROUND

• Al-Batran SE, Hartmann JT, Hofheinz R, Homann N, Rethwisch V, Probst S, Stoehlmacher J, Clemens MR, Mahlberg R, Fritz M, Seipelt G, Sievert M, Pauligk C, Atmaca A, Jager E. Biweekly fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) for patients with metastatic adenocarcinoma of the stomach or esophagogastric junction: a phase II trial of the Arbeitsgemeinschaft Internistische Onkologie. Ann Oncol. 2008 Nov;19(11):1882-7. doi: 10.1093/annonc/mdn403. Epub 2008 Jul 31.

  PMID: 18669868 BACKGROUND

• Al-Batran SE, Atmaca A, Hegewisch-Becker S, Jaeger D, Hahnfeld S, Rummel MJ, Seipelt G, Rost A, Orth J, Knuth A, Jaeger E. Phase II trial of biweekly infusional fluorouracil, folinic acid, and oxaliplatin in patients with advanced gastric cancer. J Clin Oncol. 2004 Feb 15;22(4):658-63. doi: 10.1200/JCO.2004.07.042.

  PMID: 14966088 BACKGROUND

• Al-Batran SE, Homann N, Pauligk C, Illerhaus G, Martens UM, Stoehlmacher J, Schmalenberg H, Luley KB, Prasnikar N, Egger M, Probst S, Messmann H, Moehler M, Fischbach W, Hartmann JT, Mayer F, Hoffkes HG, Koenigsmann M, Arnold D, Kraus TW, Grimm K, Berkhoff S, Post S, Jager E, Bechstein W, Ronellenfitsch U, Monig S, Hofheinz RD. Effect of Neoadjuvant Chemotherapy Followed by Surgical Resection on Survival in Patients With Limited Metastatic Gastric or Gastroesophageal Junction Cancer: The AIO-FLOT3 Trial. JAMA Oncol. 2017 Sep 1;3(9):1237-1244. doi: 10.1001/jamaoncol.2017.0515.

  PMID: 28448662 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Docetaxel; Fluorouracil; Oxaliplatin; Leucovorin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Salah Al-Batan, MD

  Institute of Clinical Cancer Research IKF, UCT - University Cancer Center, Frankfurt, Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2009
• First Posted: February 24, 2009
• Study Start: February 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2016
• Last Updated: April 6, 2016

Record last verified: 2016-04

Locations

DE (1)