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JOURNAL ONKOLOGIE – STUDIE

Adjuvant Chemotherapy in Patients With Intermediate or High Risk Stage I or Stage IIA Non-squamous Non-Small Cell Lung Cancer

Rekrutierend

NCT-Nummer:
NCT01817192

Studienbeginn:
September 2020

Letztes Update:
21.06.2021

Wirkstoff:
Adjuvant chemotherapy

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

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Razor Genomics

Collaborator:
Encore Clinical

Studienleiter

David R Spigel, MD
Principal Investigator
Sarah Cannon, The Cancer Institute of HCA Healthcare

Kontakt

Studienlocations
(3 von 29)

München-Gauting
82131 Gauting
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Silke Noeller-Granget
Phone: +49 89 85791-6472
E-Mail: s.noeller@asklepios.com

Silke Lorenz
E-Mail: sil.lorenz@asklepios.com
» Ansprechpartner anzeigen
Pius-Hospital Oldenburg Medizinischer Campus Universität Oldenburg
Oldenburg
(Niedersachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Susanne Graner
E-Mail: susanne.graner@pius-hospital.de
» Ansprechpartner anzeigen
UC Davis Comprehensive Cancer Center
95817 Sacramento
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Stacy Joo
Phone: 916-734-4913
E-Mail: ssjoo@ucdavis.edu

Jennifer Biddlecome
E-Mail: jjbiddlecome@ucdavis.edu
» Ansprechpartner anzeigen
Providence St. John's Health Center
90401 Santa Monica
United StatesNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Kathy McKenna
Phone: 310-829-8618
E-Mail: kathy.mckenna@providence.org
» Ansprechpartner anzeigen
Sarah Cannon- FCS South
33916 Fort Myers
United StatesNoch nicht rekrutierend» Google-Maps
Baptist Health Louisville
40207 Louisville
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Phyllis Thornton
Phone: 502-721-6030
E-Mail: phyllis.thornton@bhsi.com

Denise Geiger
Phone: 502-721-6030
E-Mail: karen.geiger@bhsi.com
» Ansprechpartner anzeigen
Baptist Health Paducah
42003 Paducah
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Tammy Coursey
Phone: 270-575-2413
E-Mail: tammy.coursey@bhsi.com

Betty Kuiper
Phone: 270-575-2928
E-Mail: bkuiper@bhsi.com
» Ansprechpartner anzeigen
Mercy Hospital Joplin Missouri
65804 Joplin
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Esmeralda Carillo
E-Mail: Esmeralda.Carrillo@mercy.net

Leah Klink
E-Mail: Leah.Klink@mercy.net
» Ansprechpartner anzeigen
Mercy Oncology Research St. Louis
63141 Saint Louis
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Erin Cattoor
E-Mail: Erin.Cattoor@mercy.net

Jessica Black
E-Mail: Jessica.Black@mercy.net
» Ansprechpartner anzeigen
Sarah Cannon- Messino Cancer Center
28803 Asheville
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Elizabeth Pesant
Phone: 828-212-7021
Phone (ext.): 65416
E-Mail: Elizabeth.Pesant@aoncology.com

Karen Smith
Phone: 828-212-7021
Phone (ext.): 65403
E-Mail: Karen.Smith@aoncology.co
» Ansprechpartner anzeigen
Swedish Cancer Institute
98104 Seattle
United StatesNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Andrew Smith
Phone: 206-265-2937
E-Mail: andrew.smith@swedish.org

Renae Koepke
Phone: 206-386-2441
E-Mail: renae.koepke@swedish.org
» Ansprechpartner anzeigen
La Roche-Sur-Yon - CH
85925 La Roche-sur-yon
FranceRekrutierend» Google-Maps
Ansprechpartner:
Camille Chollet
E-Mail: camille.chollet@chd-vendee.fr

Myriam Rigaudeau
E-Mail: myriam.rigaudeau@chd-vendee.fr
» Ansprechpartner anzeigen
Groupe Hospitalier Région de Mulhouse Sud -Alsace
680100 Mulhouse
FranceNoch nicht rekrutierend» Google-Maps
Centre Hospitalier Universitaire de Nîmes
30029 Nîmes
FranceNoch nicht rekrutierend» Google-Maps
Hôpital Paris Saint Joseph
75674 Paris
FranceNoch nicht rekrutierend» Google-Maps
Bordeaux - CHU
33604 Pessac
FranceNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Marine Servat
Phone: 33 5 57 65 63 38
E-Mail: marine.servat@chu-bordeaux.fr

Virginie Niel
E-Mail: virginie.niel@chu-bordeaux.fr
» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Brief Summary:

The optimal treatment for Stage I or Stage IIA non-small cell lung cancer (NSCLC) remains

controversial. Radiographic surveillance alone has been recommended for stage I and stage IIA

patients after the tumor is removed surgically from the lung, and this standard has been

based on the fact that no previous clinical trial has demonstrated a benefit for Stage I or

Stage IIA NSCLC patients who receive post-operative chemotherapy. These patients, however,

have a substantial risk of death within five years after operation, ranging from

approximately 30% to 45%, largely due to metastatic disease that is present immediately after

surgery but that is undetectable by conventional methods. Some leading organizations

therefore currently recommend post-operative chemotherapy as an alternative standard of care

in Stage I or Stage IIA NSCLC patients who are considered to be at particularly high-risk. Up

until now, however, there has not been a well-validated means to identify stage I and stage

IIA NSCLC patients at high risk of death within five years after operation. A new prognostic

tool, a 14-Gene Prognostic Assay, which has been validated and definitively demonstrated in

large scale studies to identify intermediate and high-risk stage I or Stage IIA patients with

non-squamous NSCLC, is now available to all clinicians through a CLIA-certified laboratory.

It is therefore now possible to compare the outcomes of patients randomly assigned to one or

the other of these competing standards of care.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Written informed consent

- Age ≥ 18 years

- Adequate tissue sample for the 14-Gene Prognostic Assay

- Histologically documented completely resected (R0) Stage I or Stage IIA non-squamous

NSCLC. Mixed histologies that include a squamous cell, small cell or neuroendocrine

component are eligible for the study, as long as they contain at least some component

that is neither squamous cell nor small cell nor neuroendocrine. Eligible resections

include segmentectomy, lobectomy, bi-lobectomy, sleeve lobectomy, and pneumonectomy.

Resections via wedge resection will not be eligible. Complete resection must also be

accompanied by mediastinal lymph node sampling through mediastinoscopy, bronchoscopic

sampling (e.g. endobronchial ultrasound guided biopsy) or surgical sampling. Nodes

must be sampled from at least one of the following nodal stations: Levels 2, 4, 7, 8,

9 for right- sided cancer and levels 2,4,5,6,7,8 9 for left-sided cancers.

- Life expectancy excluding NSCLC diagnosis ≥ 5 years

- ECOG performance status 0-1

- Adequate haematological function:

1. Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 AND

2. Platelet count ≥ 100000 cells/mm3 AND

3. Haemoglobin ≥ 9 g/dL (may be transfused to maintain or exceed this level)

- Adequate liver function:

1. Total bilirubin < 1.5 x upper limit of normal (ULN) AND

2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x ULN

- Adequate renal function, with Serum creatinine ≤ 1.5 x ULN

- Completely healed incisions

Exclusion Criteria:

- Final pathologic diagnosis of purse squamous cell histology, pure small cell or pure

neuroendocrine histology, or any combination of only these three histologies.

- Evidence of greater than stage II A pathologic staging

- Evidence of incomplete resection

- Pregnant or lactating women

- Unwilling to use an effective means of contraception

- Active infection, either systemic or at site of primary resection

- Prior systemic chemotherapy or anti-cancer agent

- Any pre- or post-operative radiotherapy

- Malignancies other than NSCLC within 5 years prior to randomization, except for

adequately treated CIS of the cervix, basal or squamous cell skin cancer, localized

prostate cancer treated surgically, ductal carcinoma in situ treated surgically

- Treatment with any investigational drug or participation in another clinical trial

within 28 days prior to enrollment

- Known hypersensitivity to any of the study treatment agents

- Evidence of any other disease including infection that contraindicates the use of

systemic cytotoxic chemotherapy or puts the patient at high risk for treatment related

complications

Studien-Rationale

Primary outcome:

1. Disease-Free Survival (Time Frame - 5 years):
To compare Disease Free Survival in patients with resected, stage I or IIA non-squamous NSCLC found to be at intermediate or high risk by the 14-Gene Prognostic Assay randomized to either observation or adjuvant therapy with 4 cycles of a cisplatin-based doublet.



Secondary outcome:

1. Overall Survival (Time Frame - 5 years):
To compare Overall Survival in patients randomized to each study arm. To further document the previously verified separation of the survival curves among high and low risk patients identified by the 14-Gene Prognostic Assay in this prospective cohort of stage I or IIA non-squamous NSCLC.

Studien-Arme

  • Active Comparator: Observation
    Post-operative observation of Stage I or Stage IIA non squamous non-small cell lunger cancer with Radiographic Surveillance is a current standard of care. Patients identified as low risk will be observation. Those patients identified as intermediate or high-risk by the 14-Gene Prognostic Assay will be randomized either to this arm or the Adjuvant Chemotherapy Arm.
  • Active Comparator: Adjuvant Chemotherapy
    Adjuvant Chemotherapy is a current standard of care for intermediate or high-risk Stage I or Stage IIA non-squamous non-small cell lung cancer. Patients identified as intermediate or high-risk by the 14-Gene Prognostic Assay will be randomized either to this arm or the Observation Arm.

Geprüfte Regime

  • Adjuvant Chemotherapy:
    Patients who have undergone complete resection of NSCLC that has been documented histologically to be non-squamous and that is pathological Stage I or IIA, will undergo testing with the 14-Gene Prognostic Assay. Patients determined to be intermediate or high risk and who meet all eligibility criteria will be randomized either to observation or to four cycles of adjuvant therapy with a standard NSCLC cisplatin-based doublet.
  • Radiographic surveillance:
    Serial radiographic surveillance is a current standard of care for Stage I or Stage IIA lung cancer. All intermediate or high risk patients randomized to observation or chemotherapy will have routine CT Scans at 6 month intervals until 5 years after enrollment and at yearly intervals thereafter until the end of the study period.
  • 14-Gene Prognostic Assay:
    This CLIA-approved assay is a standard tool that is now available to all clinicians to improve the prognostic evaluation of patients after resection of Stage I or Stage IIA non-squamous NSCLC. It will be performed on tumor specimens for patients who are potentially eligible for this study. Patients identified through the assay as intermediate or high-risk will be randomized to either adjuvant chemotherapy or observation.

Quelle: ClinicalTrials.gov


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