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 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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014895-23-DE

Enrollment

Registered

2013-01-17

Start date

2013-02-01

Completion date

Unknown

Last updated

2018-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced non-resectable adenocarcinoma of the stomach and the gastro-oesophageal junction MedDRA version: 15.1 Level: PT Classification code 10017758 Term: Gastric cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Pharmaceutical Form: Solution for infusion INN or Proposed INN: 5-FLOUROURACIL Other descriptive name: 5-FLOUROURACIL Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concen

Eligibility

Sex/Gender

All

Inclusion 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: 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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
Secondary end point(s): Response rate to first and second line treatment („best response“; CR, PR) • Grade of histologically assessed remission (primary tumour and distant metastases) according to Becker criteria • One- and 2-year survival rate • Percentage of patients with stable disease (SD) • Time to progression (TTP) of first and second-line treatment • NCI-CTC toxicity of first and second-line treatment • Assessment of quality of life (EORTC-QLQ-C15-PAL) and fatigue (MFI) during palliative first and second-line treatment • Impact of supportive parenteral nutrition and physical activity on quality of life and fatigue during palliative first and second-line treatment • 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	—

Measure

Time frame

Secondary end point(s): Response rate to first and second line treatment („best response“; CR, PR) • Grade of histologically assessed remission (primary tumour and distant metastases) according to Becker criteria • One- and 2-year survival rate • Percentage of patients with stable disease (SD) • Time to progression (TTP) of first and second-line treatment • NCI-CTC toxicity of first and second-line treatment • Assessment of quality of life (EORTC-QLQ-C15-PAL) and fatigue (MFI) during palliative first and second-line treatment • Impact of supportive parenteral nutrition and physical activity on quality of life and fatigue during palliative first and second-line treatment • 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

—

Countries

Germany

Contacts

Public ContactMedizinische Klinik 1

Universitätsklinikum Erlangen

axel.wein@uk-erlangen.de004991318535060

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026