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Modified Folinic Acid-Fluorouracil-Oxaliplatin (FOLFOX) Followed by Capecitabine as First-line Chemotherapy for Elderly or Frail Patients With Metastatic or Recurrent Gastric Cancer - MATURE01

Studio Clinico

Patologia: Neoplasie dello stomaco

Osservazionale-Sperimentale: Osservazionale

Monocentrico-Multicentrico: Monocentrico

Randomizzato: No

Fase di studio: Non applicabile

Linee di trattamento: Prima linea

Criteri di inclusione: 

- Elderly patients (aged ≥65 years)
- Histologically or cytologically confirmed gastric adenocarcinoma, including gastric or gastroesophageal-junction adenocarcinoma (GEJ)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (0-1 for patients aged ≥70 years, or with important comorbidity);
- Measurable disease (revised RECIST) version 1.1. based on computed tomography
- Adequate bone marrow, hepatic, and renal function, as evidenced by:
- At least 4 weeks and recovery from effects of prior major surgery or radiation therapy
- Ability to swallow an oral solid-dosage form of medication, including when a feeding tube is present
- A negative serum pregnancy test within 7 days prior to accrual in women of childbearing potential (that is, all women except those who are post menopause for > 1 year or who have a history of hysterectomy or surgical sterilization)
- Agreement to use an effective form of contraception
- Ability to comprehend and to comply with the requirements of the study
- Estimated life expectancy ≥3 months
- Adequate information and subsequent written informed consent

Criteri di esclusione: 

- Previous chemotherapy for metastatic/recurrent disease, except adjuvant chemotherapy completed at least 12 months before enrollment,
- Previous treatment with oxaliplatin
- Squamous cell gastric carcinoma
- Bone-only metastatic disease significant gastrointestinal bleeding ,
- Peripheral-neuropathy > grade 2, History or presence of brain metastasis or leptomeningeal disease
- Operable gastric or GEJ cancer
- Herceptin (HER) 2 positive disease if the subject has not previously been treated with an anti -Herceptin (HER) 2 agent
- Uncontrolled diarrhea, defined as more than 3 loose bowel movements above the subject's usual number of bowel movements on at least 3 days within the 14 days prior to study entry
- Nausea or vomiting for at least 3 consecutive days within the 14 days prior to study entry despite the administration of standard antiemetic therapy
- Known malabsorptive disorder
- Second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for 5 or more years)
- Human immunodeficiency virus infection based on history of positive serology
- Significant medical disease other than gastric cancer, including but not limited to uncontrolled diabetes mellitus, active angina or heart failure, uncontrolled hypertension, or an active psychiatric condition that would prevent consistent and compliant participation in the study
- Presence of neuropathy > Grade 1
- Prior radiation therapy to more than 25% of the bone marrow
- Need for other anticancer treatment (such as chemotherapy, radiation therapy, or biologic therapy with an approved or investigational agent) while receiving protocol therapy
- History of severe or unexpected reaction to fluoropyrimidine therapy
- History of hypersensitivity to fluoropyrimidine agents or any of their ingredients.
- Known dihydropyrimidine dehydrogenase deficiency
- Pregnancy or lactation

Trattamento sperimentale: 

FOLFOX
Capecitabine

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

Progression-free survival [ Time Frame: 6 months ]

Obiettivi secondari dello studio: 

- PFS on capecitabine maintenance [ Time Frame: 6 months ]
- Overall survival [ Time Frame: 12 months ]
- Number of patients with adverse events [ Time Frame: 12 months ]
- time to treatment failure [ Time Frame: 12 months ]

Centri partecipanti

Centro Italia

Ospedale S. Salvatore
Via Lombroso 1 - 61122 Pesaro - PU
UOC Oncologia

Riferimento: Dr. Vincenzo Catalano
Telefono: 0721364001
Email: catalano_v@yahoo.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NCT02002195

Data di inserimento: 12.07.2019

Promotore

Azienda Ospedaliera ospedali Riuniti Marche Nord - PO San Salvatore, Pesaro

Riferimento: Dr. Vincenzo Catalano

CRO

NA

Principal Investigator ITALIA

Azienda Ospedaliera Ospedali Riuniti Marche Nord, Presidio Ospedaliero San Salvatore-Pesaro

Riferimento: Dr. Vincenzo Catalano

Telefono: 0721364001

Email: catalano_v@yahoo.it

Localita: Pesaro

 

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