EUCTR2009-014895-23-DE
Active, not recruiting
Phase 1
Phase II clinical trial of a sequential therapy involving the FLOT regiment in palliative first-line treatment followed by AIO plus irinotecan in second-line treatment combined with supportive parenteral nutrition and physical activity in patients with advanced non-resectable adenocarcinoma of the stomach and the gastro-oesophageal junction - impact on quality of life and fatigue: FLOTIRI - gastric cancer trial - FLOTIRI
niversitätsklinikum Erlangen0 sites50 target enrollmentJanuary 17, 2013
ConditionsAdvanced non-resectable adenocarcinoma of the stomach and the gastro-oesophageal junctionMedDRA version: 15.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Advanced non-resectable adenocarcinoma of the stomach and the gastro-oesophageal junction
- Sponsor
- niversitätsklinikum Erlangen
- Enrollment
- 50
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically proven advanced adenocarcinoma of the stomach or the gastro\-oesophageal junction with distant metastases including lymph node metastasis, e.g. supraclavicular or para\-aortal (M1 \[HEP, PUL, LYM] (UICC stage IV)
- •Age: \= 18 und \= 75 years
- •Life expectancy: minimum 3 months
- •ECOG index 0\-2
- •Sufficient bone marrow function defined as leucozytes ? 3\.500/µl, thrombocytes ? 100\.000/µl
- •Sufficient renal function defined as serum creatinine ? 2,0 mg/dl or creatinin clearance \> 30 ml/min.
- •Sufficient hepatic function defined as serum bilirubine ? 2,0 mg/dl, exception: orbus Gilbert\-Meulengracht
- •Signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
Exclusion Criteria
- •Hypersensibility to 5\-FU, sodium folinate, irinotecan, docetaxel oder oxaliplatin
- •Previous systemic chemotherapy
- •Severe concomitant diseases which preclude therapy
- •Bone marrow suppression
- •Chronic diarrhoea (\> NCI – CTC \- grade 1\)
- •Chronic inflammatory intestinal diseases or subtotal intestinal obstruction
- •Concomitant therapy with other anticancer drugs
- •Treatment with allopurinol and trimethroprim
- •Pregnancy and lactation
- •No adequate contrazeption for pre\-menopausal females
Outcomes
Primary Outcomes
Not specified
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