E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
TRIFLURIDINE/TIPIRACIL (FTD/TPI) with or without bevacizumab in patients with platinum-refractory esophago-gastric adenocarcinoma |
Et randomiseret fase III studie med TRIFLURIDINE/TIPIRACIL (FTD/TPI) med eller uden bevacizumab til patienter med platin-resistent Øsofago-gastrisk adenocarcinom (LON-GAS). |
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E.1.1.1 | Medical condition in easily understood language |
Randomised trial in patients with advanced cancer in esophagus and stomach with Lonsurf with or without bevacizumab |
Lodtrækningsforsøg til patienter med udbredt kræft i spiserør, mavemund og mavesæk med Lonsurf med eller uden bevacizumab |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The purpose of this study is to evaluate the efficacy and tolerability of Lonsurf with or without bevacizumab in Caucasian patients with platinum-refractory esophago-gastric adenocarcinoma. Primary objective is Progression Free Survival (PFS) |
Formålet med studiet er at evaluere effekt og sikkerhed af Lonsurf med eller uden bevacizumab til kaukasiske patienter med platin-behandlet kræft i spiseør, mavemund og mavesæk. Det primære endemål er Progressionsfri Overlevelse (PFS) |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives include Overall survival (OS), Response rate (RR), Disease Control Rate, Time to Deterioration (TtD) in Performance Status, Toxicity and Correlation between bio-markers and outcome
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Sekundære endemål omfatter overlevelse (OS), responsrate (RR), disease control rate (DCR), tid til forværring i Performance Status (PS), bivirkninger og relation mellem biomarkører og effektmål. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
o Age ≥ 18 years.
o Histologically verified esophago-gastric adenocarcinoma (EGA).
o Non-resectable and/or metastatic disease.
o Measurable or non-measurable disease.
o Performance status (WHO) of 0-1 and a life expectancy of at least 3 months.
o Previous therapy with fluoropyrimidines (5FU, capecitabine or S-1) and platinum (cisplatin, oxaliplatin, or carboplatin).
o Adequate haematological function defined as neutrophils 1.5 x 109/l and platelets ≥ 100 x 109/l.
o Adequate organ function (bilirubin ≤ 1.5 x UNL (upper normal limit), GFR (may be calculated) > 30 ml/min.
o Woman of childbearing potential must have been tested negative in a serum pregnancy test within 5 days prior to randomisation. Male and female patients who have the potential to reproduce must agree to use a highly effective method of birth control. (i.e., pregnancy rate of less than 1 % per year) during the study and for 6 months after the discontinuation of study medication.
o Has provided written informed consent prior to performance of any study procedure.
o Written informed consent must be obtained according to the local Ethics Committee requirements.
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Histologisk verificeret metastaserende platin-resistent EGA.
• Målelig eller ikke-målelig sygdom.
• Performance status 0-1 og forventet restlevetid på mindst tre måneder.
• Tilfredsstillende blodprøver defineret ved neutrofile ≥ 1,5 x 109/l og blodplader ≥ 100 x 109/l.
• Tilfredsstillende organfunktion defineret som S-bilirubin ≤ 1,5 x UNL (øvre normalværdi), GFR (kan udregnes) > 30 ml/min.
• Fertile kvinder skal indvilge i at anvende relevante præventionsmidler fra behandlingsstart til 6 måneder efter behandlingsophør. Fertile kvinder skal have taget en negativ graviditetstest maks. 5 dage før randomiseringen. Mænd skal indvilge i at anvende relevante præventionsmidler fra behandlingsstart til 6 måneder efter behandlingsophør.
• Skriftligt informeret samtykke.
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E.4 | Principal exclusion criteria |
o Prior history of cancer, except cervix in situ carcinoma, in situ urothelial carcinoma or previously treated and cured skin basocellular, and except any other cancer in complete remission for at least 2 years.
o Any other condition or therapy, which in the investigator’s opinion may pose a risk to the patient or interfere with the study objectives (e.g. infection; drainage of ascites or pleural effusion within 4 weeks; intestinal obstruction; uncontrolled diabetes; AMI within 12 months; severe/unstable angina; known HIV or hepatitis B or C; major surgery within 4 weeks; uncontrolled hypertension).
o Known allergy or intolerance to any of the drugs used (Lonsurf, bevacizumab).
Known CNS metastasis
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Anden tidligere malign sygdom med mindre denne har været i komplet remission i mindste to år.
• Enhver tilstand eller behandling som efter behandlende læges skøn kan udgøre en risiko for patienten, eller som kan hæmme formålet med studiet, herunder infektion, drænage af ascites eller pleuraeffusionn indenfor 4 uger, intestinal obstruktion, ukontrolleret diabetes, AMI indenfor 12 måneder, ustabil angina, HIV infektion, Hepatitis B eller C, større kirurgi indenfor de sidste 4 uger, ukontrolleret hypertension.
Kendte CNS metastaser |
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E.5 End points |
E.5.1 | Primary end point(s) |
Progression Free Survival (PFS) |
Progressionsfri Overlevelse (PFS) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
6 months after end of trial (last visit last patient) |
6 måneder efter forsøgets afslutning (last visit last patient) |
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E.5.2 | Secondary end point(s) |
Secondary objectives include Overall survival (OS), Response rate (RR), Disease Control Rate (DCR), Time to deterioration (TtD) in Performance Status (PS), Toxicity and Correlation between bio-markers and outcome |
Sekundære endemål omfatter overlevelse (OS), responsrate (RR), disease control rate (DCR), tid til forværring i performance status, bivirkninger og relation mellem biomarkører og effektmål. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
6 months after end of trial (last visit last patient) |
6 måneder efter forsøgets afslutning (last visit last patient) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LVLS |
Sidste patient sidste besøg |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |