Clinical Research Platform Into Molecular Testing, Treatment and Outcome of (Non-)Small Cell Lung Carcinoma Patients

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT02622581

Studienbeginn:
Dezember 2015

Letztes Update:
06.02.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
AIO-Studien-gGmbH

Collaborator:
AstraZeneca, Celgene Corporation, Merck Sharp & Dohme LLC, Novartis Pharmaceuticals, Pfizer, Boehringer Ingelheim, Bristol-Myers Squibb, iOMEDICO AG, Eli Lilly and Company, Roche Pharma AG, Takeda, Amgen, Janssen-Cilag G.m.b.H, GlaxoSmithKline Research & Development L

Studienleiter

Frank Griesinger, Prof. Dr.
Principal Investigator
Pius-Hospital Oldenburg

Kontakt

Annette Hipper, Dr.
Kontakt:
E-Mail: annette.hipper@aio-studien-ggmb.de» Kontaktdaten anzeigen

Annika Groth
Kontakt:
E-Mail: Annika.Groth@aio-studien-ggmbh.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Darmkrebszentrum Oldenburg, Pius-Hospital
Georgstraße 12
26121 Oldenburg
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
F. Griesinger, Prof.
Phone: +49 441 229 1611
E-Mail: Frank.griesinger@pius-hospital.de» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

Thorough knowledge of the treatment reality, e.g. characteristics, diagnostic, treatment and

outcome of unselected patients in real-life practice, is crucial to evaluate and improve the

quality of care for patients with non-small cell lung cancer (NSCLC) and small cell lung

cancer (SCLC).

The purpose of CRISP is to set up a national clinical research platform to document uniform

data on the molecular testing, treatment, course of disease in patients with NSCLC or SCLC. A

particular focus is on molecular biomarker testing before the start of first-line treatment

of patients with advanced or metastatic NSCLC. The data shall be used to assess the current

state of care and to develop recommendations concerning topics that could be improved.

PRO assessment will provide large-scale data on quality of life and anxiety/depression for

real-life patients with NSCLC or SCLC in routine practice. In addition, two questionnaires

(concerning individual quality of life and patient-caregiver communication) will be validated

in German patients with metastatic NSCLC.

Furthermore, CRISP will set up a decentralized clinically annotated tissue repository for

future collaborative, investigational scientific biomarker testing.

Ein-/Ausschlusskriterien

Inclusion Criteria:

Patients who meet all of the following criteria are eligible for the project:

- Age ≥ 18 years

- Able to understand and willing to sign written Informed Consent and to complete

patient-reported-outcome assessment instruments

Main project (Metatstatic NSCLC):

- Confirmed non-small cell lung cancer (NSCLC)

- Informed consent no later than four weeks after start of first-line systemic treatment

or no later than four weeks after diagnosis for patients receiving "best supportive

care only"

- Stage IV, or stage IIIB/C (UICC8) if patient is ineligible for curative surgery and/or

radiochemotherapy

- Systemic therapy or best supportive care

Satellite Stage I/II/III (NSCLC):

- Confirmed non-small cell lung cancer (NSCLC)

- Informed consent no later than four weeks after start of first anti-tumor treatment

(including surgery and radiotherapy) or no later than four weeks after diagnosis for

patients receiving "best supportive care only" (i.e. no anti-tumor treatment = no

surgery, radiotherapy or systemic therapy)

- Stage I, Stage II, stage IIIA, or stage IIIB/C (UICC8)

- Systemic (chemo)therapy and/or radiation therapy and/or surgery or best supportive

care

Satellite SCLC

- Confirmed Small cell lung cancer (SCLC)

- Informed consent no later than four weeks after start of first anti-tumor treatment or

no later than four weeks after diagnosis for patients receiving "best supportive care

only" (i.e. no anti-tumor treatment = no surgery, radiotherapy or systemic therapy)

- Systemic (chemo)therapy and/or radiation therapy and/or surgery or best supportive

care

Exclusion Criteria:

none

Studien-Rationale

Primary outcome:

1. biomarker (Time Frame - 3 years):
To collect data on the frequency, methodology and results of molecular biomarker testing before first-line and later-line treatment

2. treatment (Time Frame - 3 years):
To describe systemic treatments and sequential treatments applied in real-life practice

3. Response rate (Time Frame - 3 years):
To assess effectiveness of systemic treatments in regards to response rate.

4. progression free survival (Time Frame - 3 years):
To assess effectiveness of systemic treatments in regards to progression free survival.

5. overall survival (Time Frame - 3 years):
To assess effectiveness of systemic treatments in regards overall survival.

6. physician-reported factors (Time Frame - 3 years):
To describe physician-reported factors affecting treatment decision making besides biomarker profiling

7. supportive therapies (Time Frame - 3 years):
to collect key data on specific supportive therapies

8. changes during the project (Time Frame - 3 years):
To investigate changes in diagnostics, treatment or outcome during the course of the project

9. general health-related and individual quality of life (QoL) patient-reported outcomes (Time Frame - 3 years):
To evaluate patient-reported outcomes concerning (1) general health-related and individual quality of life (QoL). and depression, (4) patient-caregiver communication

10. physical and psychological well-being patient-reported outcomes (Time Frame - 3 years):
To evaluate patient-reported outcomes concerning physical and psychological well-being.

11. anxiety patient-reported outcomes (Time Frame - 3 years):
To evaluate patient-reported outcomes concerning anxiety.

Studien-Arme

NSCLC, Non-squamous cell carcinoma
Patients with locally advanced or metastatic NSCLC at the start of palliative first-line systemic therapy or receiving best supportive care. At least 3,250 patients with non-squamous cell carcinoma will be tested for molecular alterations. (CRISP)
NSCLC, Squamous cell carcinoma
Patients with locally advanced or metastatic NSCLC at the start of palliative first-line systemic therapy or receiving best supportive care. At least 1,750 patients with squamous cell carcinoma that possibly will be tested for molecular alterations. (CRISP)
NSCLC, Non-squamous cell carcinoma (not tested)
Patients with locally advanced or metastatic NSCLC at the start of palliative first-line systemic therapy or receiving best supportive care. Up to 5,000 patients not tested for molecular alterations (CRISP satellite untested patients stage IIIB/IIIC/IV).).
NSCLC, Stage I/II/III
Up to 1600 patients with NSCLC stage I, or stage II, or stage IIIA, or with NSCLC stage IIIB/C if they are eligible for curative surgery and/or radiochemotherapy, or are receiving best supportive care
Small cell lung cancer (SCLC)
Up to 1200 patients with SCLC (limited stage (LD) or extensive stage (ED)) if they are eligible for surgery and/or radio(chemo)therapy and/or systemic therapy, or are receiving best supportive care

Geprüfte Regime

data collection:
Baseline (demographic, clinical, tumor) characteristics, details on biomarker testing, including re-testing, treatment decision making, all systemic anticancer therapies including details, key data on radiotherapies, surgeries and specified supportive therapies, outcome (response, progression, survival), course of disease. Data will be documented at baseline and updated at least every three months.

Quelle: ClinicalTrials.gov

Sie können folgenden Inhalt einem Kollegen empfehlen:

"Clinical Research Platform Into Molecular Testing, Treatment and Outcome of (Non-)Small Cell Lung Carcinoma Patients"

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!