Phase II clinical trial of palliativ treatment of patients with advanced non-operable gastric carcinoma: FLOT regimen followed by AIO regimen and irinotecan combined with artificial nutrition and physical activity - impact on quality of life and fatigue: FLOTIRI gastric cancer trial

Phase 1

• Conditions: Advanced non-resectable adenocarcinoma of the stomach and the gastro-oesophageal junction; MedDRA 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]

• Registration Number: EUCTR2009-014895-23-DE
• Lead Sponsor: niversitätsklinikum Erlangen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-17
• Last Update Posted: 24 September 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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
•Participation in clinical trials with non-approved drugs

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Median survival;Secondary Objective: •Response rate to first and second line treatment („best response; CR, PR)<br>•Grade of histologically assessed remission (primary tumour and distant metastases) according to Becker criteria <br>•One- and 2-year survival rate<br>•Percentage of patients with stable disease (SD)<br>•Time to progression (TTP) of first and second-line treatment<br>•NCI-CTC toxicity of first and second-line treatment<br>•Assessment of quality of life (EORTC-QLQ-C15-PAL) and fatigue (MFI) during palliative first and second-line treatment<br>•Impact of supportive parenteral nutrition and physical activity on quality of life and fatigue during palliative first and second-line treatment<br>•Percentage of secondary curative resection of metastases (after downsizing by palliative first-line treatment<br>;Primary end point(s): Median survival;Timepoint(s) of evaluation of this end point: Last visit last subject

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Response rate to first and second line treatment („best response; CR, PR)<br>•Grade of histologically assessed remission (primary tumour and distant metastases) according to Becker criteria <br>•One- and 2-year survival rate<br>•Percentage of patients with stable disease (SD)<br>•Time to progression (TTP) of first and second-line treatment<br>•NCI-CTC toxicity of first and second-line treatment<br>•Assessment of quality of life (EORTC-QLQ-C15-PAL) and fatigue (MFI) during palliative first and second-line treatment<br>•Impact of supportive parenteral nutrition and physical activity on quality of life and fatigue during palliative first and second-line treatment<br>•Percentage of secondary curative resection of metastases (after downsizing by palliative first-line treatment;Timepoint(s) of evaluation of this end point: Last visit last subject