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JOURNAL ONKOLOGIE – STUDIE
CRISP

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

Rekrutierend

NCT-Nummer:
NCT02622581

Studienbeginn:
Dezember 2015

Letztes Update:
07.04.2020

Wirkstoff:
-

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

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
AIO-Studien-gGmbH

Collaborator:
AstraZeneca, Celgene Corporation, Merck Sharp & Dohme Corp., Novartis Pharmaceuticals, Pfizer, Boehringer Ingelheim, Bristol-Myers Squibb, iOMEDICO AG, Eli Lilly and Company, Roche Pharma AG, Takeda, Amgen,

Studienleiter

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

Kontakt

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

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

- Systemic therapy

Satellite Stage II/III (NSCLC):

- Confirmed non-small cell lung cancer (NSCLC)

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

- Stage II, stage IIIA, or stage IIIB/C (UICC8) if patient is eligible for curative surgery and/or radiochemotherapy

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

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. 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. 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. Not tested for molecular alterations (CRISP satellite untested patients stage IIIB/IIIC/IV).).
  • NSCLC, Stage II/III
    800 patients with NSCLC stage II, or stage IIIA, or with NSCLC stage IIIB/C if they are eligible for curative surgery and/or radiochemotherapy
  • 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


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