- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01360086
Fluorouracil, Cisplatin, Leucovorin Calcium, and Cetuximab in Treating Patients With Adenocarcinoma of the Stomach or Gastroesophageal Junction
Trial Evaluating the Efficacy and Tolerance of Perioperative Chemotherapy With 5FU-Cisplatin-Cetuximab in Adenocarcinomas of the Stomach and Gastroesophageal Junction. Phase II Single Arm, Multicenter.
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, cisplatin, and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving more than one drug (combination chemotherapy) together with cetuximab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these drugs after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying the side effects of giving fluorouracil, cisplatin, and leucovorin calcium together with cetuximab and to see how well they work in treating patients with adenocarcinoma of the stomach or gastroesophageal junction.
Studienübersicht
Status
Detaillierte Beschreibung
OBJECTIVES:
Primary
- To evaluate the objective response rate according to RECIST V1.1 criteria in patients with adenocarcinoma of the stomach or gastroesophageal junction treated with neoadjuvant chemotherapy comprising fluorouracil, cisplatin, leucovorin calcium, and cetuximab followed by surgery and adjuvant chemotherapy.
- To determine the non-toxicity rate in these patients.
Secondary
- To determine the rate of macroscopically and microscopically complete surgical resection (R0).
- To determine the overall tolerance in patients treated with this regimen.
- To determine post-operative mortality and morbidity in these patients.
- To determine the rate of recurrence at 1 and 2 years in these patients.
- To determine recurrence-free survival at 3 years in these patients.
- To determine disease-free survival at 3 years in these patients.
- To determine overall survival at 3 years in these patients.
- To determine quality of life using EORTC QLC-C30 and STO-22 questionnaires.
- To determine the correlation between the response rate and the degree of skin toxicity.
OUTLINE: This is a multicenter study.
- Neoadjuvant therapy and surgery: Patients receive leucovorin calcium IV over 2 hours, cisplatin IV, fluorouracil IV continuously over 46 hours, and cetuximab IV over 1-2 hours on day 1. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Within 3-4 weeks after completing neoadjuvant chemotherapy, patients undergo surgery.
- Adjuvant therapy: Within 4-8 weeks after completing neoadjuvant chemotherapy, patients receive leucovorin calcium, cisplatin, fluorouracil, and cetuximab as in neoadjuvant therapy. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients complete quality-of-life questionnaires (QLC-C30 and STO-22) periodically. Blood and tissue samples are collected periodically for correlative and translational studies.
After completing study therapy, patients are followed up every 4 months for 2 years and then every 6 months for 1 year.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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Lille, Frankreich, 59037
- Centre Hospitalier Regional et Universitaire de Lille
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Reims, Frankreich, 51092
- CHU - Robert Debre
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
Stage IB, II, or III disease according to TNM classification OR type I, II, or III disease according to Siewert classification
- TNM: T1N1-3, T2N0-3, T3N0-3, or T4N0-3 (no T1N0 or M1)
- Disease considered operable with curative intent
No gastric scirrhous carcinoma (linitis plastica)
- Forms with independent cells are not considered linitis
- Measurable disease according to RECIST V1.1
- No planned esophagectomy without thoracotomy in patients with adenocarcinoma of the gastroesophageal junction type I
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Polynuclear neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Creatinine clearance > 50 mL/min
- Bilirubin < 1.5 times normal
- Serum albumin > 30 g/L
- Prothrombin time ≥ 80%
- FEV1 > 1 L in case of thoracotomy
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known cirrhosis
No other progressive condition that has not been stabilized including the following:
- Hepatic failure
- Renal failure
- Respiratory failure
- NYHA class III-IV congestive heart failure
- Unstable angina
- Myocardial infarction in the past 6 months
- Significant arrhythmias in the past 12 months
- No recent weight loss exceeding 15%
- No interstitial pneumonia
- No other malignant tumor within the past 5 years except for basal cell skin carcinoma or cancer in situ of the cervix
- No psychological, familial, or geographical reasons that will preclude the patient being monitored regularly
- No persons deprived of liberty or under guardianship (Disability Act)
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy or radiotherapy for gastric cancer
- No other concurrent anticancer treatment, immunotherapy, or hormone therapy
- No prior abdominal or thoracic radiotherapy
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Perioperative CT with 5FU-Cisplatine-Cetuximab
6 cycles of intravenous Cetuximab (500mg/m²), Cisplatine (50mg/m²) and LV5FU2s (folinic acid 400mg/m², 5FU bolus 400mg/m², and continuous infusion of 5FU 2400mg/m²) every 2 weeks.
Surgery was planned 3-4 weeks after the end of neaodjuvant CT and postoperative CT, with the same regimen, planned for 6-8 weeks after surgery.
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6 cycles of intravenous Cetuximab (500mg/m²),
Cisplatine (50mg/m²)
LV5FU2s (folinic acid 400mg/m², 5FU bolus 400mg/m², and continuous infusion of 5FU 2400mg/m²) every 2 weeks
Surgery was planned 3-4 weeks after the end of neaodjuvant CT
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Objective response rate according to RECIST V1.1 criteria
Zeitfenster: 3 months
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3 months
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Non-toxicity rate
Zeitfenster: 3 months
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3 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Krankheitsfreies Überleben nach 3 Jahren
Zeitfenster: 3 Jahre
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3 Jahre
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Gesamtüberleben nach 3 Jahren
Zeitfenster: 3 Jahre
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3 Jahre
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Tolerance
Zeitfenster: From Inclusion
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From Inclusion
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Post-operative mortality and morbidity
Zeitfenster: After Surgery
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After Surgery
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Rate of recurrence at 1 and 2 years
Zeitfenster: 1 year and 2 years
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1 year and 2 years
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Rezidivfreies Überleben nach 3 Jahren
Zeitfenster: 3 Jahre
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3 Jahre
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Quality of life as assessed by QLC-C30 and STO-22 questionnaires
Zeitfenster: From inclusion
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From inclusion
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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Christophe Mariette, MD, PhD, Centre Hospitalier Regional et Universitaire de Lille
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Verdauungssystems
- Neubildungen nach histologischem Typ
- Neubildungen
- Neubildungen nach Standort
- Karzinom
- Neubildungen, Drüsen und Epithelien
- Gastrointestinale Neubildungen
- Neoplasmen des Verdauungssystems
- Magen-Darm-Erkrankungen
- Magenerkrankungen
- Kopf-Hals-Neubildungen
- Erkrankungen der Speiseröhre
- Magenneoplasmen
- Adenokarzinom
- Ösophagusneoplasmen
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Antimetaboliten, antineoplastisch
- Antimetaboliten
- Antineoplastische Mittel
- Immunsuppressive Mittel
- Immunologische Faktoren
- Schutzmittel
- Antineoplastische Mittel, immunologische
- Mikronährstoffe
- Vitamine
- Calciumregulierende Hormone und Wirkstoffe
- Gegenmittel
- Vitamin B-Komplex
- Cisplatin
- Fluorouracil
- Leucovorin
- Kalzium
- Levoleucovorin
- Cetuximab
Andere Studien-ID-Nummern
- CDR0000699219
- FFCD-0901
- EU-21111
- EUDRACT-2010-023115-33
- MERCK-FFCD-0901
Plan für individuelle Teilnehmerdaten (IPD)
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