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Studien: AGMT_SAKK 41/14 ACTIVE-2  |  AGMT_ERCC1 |  AGMT-Capecet_PK |  KRK 0504 |  Protokoll 86 |  Protokoll 87 |  Protokoll 89 | 

 


AGMT_SAKK 41/14 ACTIVE-2

Coordinating Investigator: Prof. Dr. Josef Thaler
Fallzahl: 542
Start: Q2 2016 | Ende: Q3 2026
Status: recruiting


Physical activity program in patients with metastatic colorectal cancer who receive palliative first-line chemotherapy. A multicenter open label randomized controlled phase III trial

Studiendesign

All patients will undergo standard systemic therapy for metastatic colorectal cancer. Patients in the care-as-usual group are not actively encouraged to change their physical activity level e.g. to start a fitness program during chemotherapy.

The physical exercise ACTIVE-program describes a 12-week exercise program consisting of a combination of a bi-weekly aerobic exercise (cycle ergometer) supervised by a physical therapist and a self-paced increase in physical activity during daily life using a pedometer with a daily step goal as a motivational tool. The program will be individually tailored to each patient based on the training protocol and is aimed at increasing physical activity levels and cardiorespiratory fitness.

Studienziele

To assess whether a structured physical activity program (PA) during palliative chemotherapy improves progression-free survival (PFS) and/or patient-reported outcomes (ESAS-r—Edmonton Symptom Assessment System) in patients with metastatic colorectal cancer.

Einschlusskriterien (Auszug)

• Written informed consent according to ICH/GCP regulations before randomization.
• Patient with histologically or cytologically confirmed colorectal carcinoma (CRC) required to start palliative first-line systemic therapy for inoperable or metastatic disease.
• Patients who were diagnosed with histologically or cytologically confirmed non-metastatic CRC earlier and now relapsed with metastatic disease are also eligible, if any prior neoadjuvant or adjuvant chemotherapy has been completed more than 4 months before inclusion into this trial.
• Patient has measurable disease on CT scan or MRI to be performed within 4 weeks before randomization (measurability criteria according to RECIST 1.1 [1], non-nodal lesions ≥ 10mm, lymph nodes ≥ 15mm OR evaluable disease i.e. patient with nonmeasurable metastases but elevated serum tumor-marker (CEA at least >2xULN).
• Command of written and spoken language allowing for informed consent and for filling in trial questionnaires.
Baseline patient-reported outcomes (PROs) have been completed.
• WHO performance status 0-2.
• Age 18-75 (80) years (if WHO is 0-1 upper age limit is 80 years)

Öffentliche Downloads

AGMT_SAKK 41/14 ACTIVE-2 Poster
Poster am OeGHO 20167



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AGMT_ERCC1

Coordinating Investigator: OA Dr. Alois Lang; Dr. Thomas Winder
Fallzahl: 50
Start: Q3 2012 | Ende: Q2 2015
Status: recruiting


Biomarker directed treatment in metastatic colorectal cancer

Studiendesign

The study will consist of two parts:
•  Pre-Screening phase
•  Treatment phase for KRAS and NRAS wt patients

Pre-Screening phase:
Central Evaluation of KRAS/NRAS status and ERCC-1 gene expression will be evaluated in a central laboratory.

Treatment phase:
RAS wt patients will be treated with 6 cycles of one of the following regimens chosen for optimization based on patient characteristics (primary treatment phase). Patients with ERCC-1 < 1.7 relative gene expression of ERCC-1 over ß-actin (ERCC-1 low) will be assigned to treatment with mFOLFOX6 in combination with Cetuximab. Patients with ERCC-1 gene expression > 1.7 relative gene expression of ERCC-1 over over ß-actin (ERCC-1 high) will be assigned to treatment with FOLFIRI in combination with Cetuximab.

Studienziele

Primary objective
To assess treatment response (according to Response Evaluation Criteria In Solid Tumors [RECIST])in patients with previous untreated wt RAS advanced colorectal cancer (since protocol version 3.1, dated 25.10.2013, patients with mutant KRAS and mutant NRAS are excluded) using mFOLFOX6 or FOLFIRI and cetuximab with therapy chosen using ERCC-1 gene expression assessment.

Secondary objectives
•  Progression free survival (PFS) and overall survival (OS)
•  Description of group differences between ERCC-1 low and ERCC-1 high pat.with respect to response rate.
•  Description of group differences between ERCC-1 low and ERCC-1 high patients with respect to KRAS and NRAS status
•  Secondary resection rate
•  Molecular markers for toxicity
•  To assess toxicity

Einschlusskriterien (Auszug)

Inclusion criteria for pre-screening phase:

•  Informed Consent
•  Untreated advanced metastatic colorectal cancer patients
•  Adequate tissue to evaluate for genotyping

Inclusion criteria for treatment phase:

Patients must fulfil all criteria listed below prior to enrolment in the study:
•  Untreated wild-type RAS metastatic colorectal cancer patients
•  Previous adjuvant therapy must have been completed > 6 months
•  Age >18 years
•  Evaluable disease with CT or MRI
•  ECOG performance status of 0-2
•  Hematologic: Absolute neutrophil count > 1,500/µL Hemoglobin >9 mg/dl; Platelet count >100,000 /µl
•  Renal: Serum creatinine <1.5 x Upper limit of normal (UPN) or estimated clearance > 30 ml/min
•  Hepatic: Serum bilirubin < 1.5 mg/dl

Öffentliche Downloads

AGMT_ERCC1 Poster
Poster am OeGHO 2017



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AGMT-Capecet_PK

Coordinating Investigator: Univ. Prof. Dr. Christian Dittrich
Fallzahl: 24
Start: Q4 2011 | Ende: Q2 2013
Status: completed


Pharmacokinetics and metabolic activation of capecitabine when given concomitantly with oxaliplatin and the monoclonal antibody cetuximab

Studiendesign

This study is designed as a multicentre, randomised phase II trial with 24 first-line patients with metastatic K-ras wild-type CRC patients.
Patients with histologically confirmed, K-ras wild-type CRC without previous chemo-therapy for metastatic disease will be screened for this study.
Patients will be randomized in a ratio of 1:1 into two groups:

Group A:
Capecitabine in weeks 1, 2, 4, 5, 7 and 8
Cetuximab in weeks 3 to 9
Oxaliplatin in week 7

Group B:
Capecitabine in weeks 1, 2, 4, 5, 7 and 8
Cetuximab in weeks 1, 8 and 9
Oxaliplatin in week 7

This PK study has a prospective cross over design with patients serving as their own controls to minimize problems associated with inter patient variability.

Studienziele

The objective of this pharmacokinetic study is to exclude a possible influence of CETUX on the plasma disposition and metabolic activation of CCB and when this regimen is given combined with OxPt.
1st objective:
investigation of a possible modulation of co-administered CETUX on the metabolic activation of CCB

2nd objective:
investigation of a possible modulation of co-administered CETUX on the metabolic activation of CCB, when administered concomitantly with OxPt

Einschlusskriterien (Auszug)

For inclusion in the study, all of the following inclusion criteria must be fulfilled:
• Signed written informed consent
• Male or female ≥ 18 years of age
• Diagnosis of histologically confirmed, K-ras "wild-type" adenocarcinoma of the colon or rectum
• Metastatic colorectal carcinoma
• ECOG ≤ 2
• Eligible for therapy with Cetuximab plus Oxaliplatin and/or Capecitabine
• Leucocytes ≥ 3.0 x 10e9/L
• Neutrophils ≥ 1.5 x 10e9/L
• Platelets ≥ 100 x 10e9/L
• Hemoglobin ≥ 8 g/dL
• Bilirubin ≤ 1.5 x ULN
• ASAT and ALAT ≤ 2.5 x ULN (≤ 5 x ULN if liver metastasis are present)
• Serum creatinine ≤ 1.5 x ULN
• Adequate contraception (male or female patients) if of childbearing or procreational potentia



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KRK 0504

Coordinating Investigator: Prof. Dr. Richard Greil/ AIO
Fallzahl: 120
Start: Q4 2006 | Ende: Q4 2009
Status: geschlossen


Zweitlinientherapie AIO-IRI/ FOLFIRI/ CAPIRI/ XELIRI +/- Bevacizumab bzw. FUFOX/ FOLFOX/ CAPOX/ XELOX +/- Bevacizumab bei Patienten mit metastasiertem kolorektalem Karzinom nach Progress unter Erstlinientherapie mit Fluoropyrimidin/ Oxaliplatin- Bevacizumab bzw. Fluoropyrimidin/ Irinotecan- Bevacizumab

Studienziele

Primärer Endpunkt: Progressionsfreie Zeit
Sekundäre Endpunkte: Gesamtüberlebenszeit; Remissionsraten; Toxizitäten

Einschlusskriterien (Auszug)

Histologisch gesichertes, metastasiertes und inoperables Kolorektalkarzinom, Progression auf Bevacizumab-hältige Chemoimmuntherapie innerhalb von 3 Monaten nach der letzten Bevacziumabgabe, Alter 18 Jahre und älter



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Protokoll 86

Coordinating Investigator:
Fallzahl:
Start: | Ende:
Status: geschlossen


5FU/Leucovorin vs. 5FU/Leucovorin/IFNa2c in der Therapie des metastasierenden Kolorektalkarzinoms



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Protokoll 87

Coordinating Investigator:
Fallzahl:
Start: | Ende:
Status: geschlossen


Randomisierte Multizentrische Studie zur Erfassung der Wertigkeit von IFNa als Erhaltungstherapie bei CR/ PR beim metastasierenden Kolorektalkarzinom



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Protokoll 89

Coordinating Investigator:
Fallzahl:
Start: | Ende:
Status: geschlossen


Palliative Kolorektalstudie



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