Behaviors and Mental Disorders

All Conditions

Quality of Life

Patient-reported outcomes are electronically assessed using EORTC QOL measures

Patient-reported outcomes assessment

CTCAE Ratings are conducted by clinicians

CTCAE rating

PRO data is displayed right next to the CTCAE rating

PRO data is displayed

Bernhard Holzner, Prof. PhD

August Zabernigg, MD

This open randomized trial investigates, if clinicians complete CTCAE ratings differently when receiving patients' patient-reported outcome (PRO) data prior to their CTCAE completion. The primary objective is to demonstrate superior inter-rater reliability of CTCAE ratings from physicians relying on EORTC PRO data as additional data source over traditional CTCAE ratings not including PRO information.

In oncology, detection and tracking of adverse events (AEs) are a top priority in both clinical trials and routine care. The classification of AEs mostly relies on the Common Toxicity Terminology for Adverse Events (CTCAE) developed by the US-American National Institutes of Health and the National Cancer Institute.

It is known, however, that the assessment of AEs can greatly vary depending on whether they are assessed by patients or by clinicians.

Procedure: The patients (any oncological diagnosis, day clinic or inpatient for treatment with chemotherapy or immunotherapy; open 1:1 randomized) fill out an EORTC quality of life questionnaire electronically (C30 + further questions). These PRO data are immediately available for the clinicians. Independently of each other, two different clinicians conduct a medical consultation with the patient and electronically a CTCAE rating. For the intervention Group, clinicians see the PRO values directly next to the input options for the CTCAE rating. For the control Group, clinicians see the input options for the CTCAE rating. The similarity of the assessments is checked using intra-class correlation.

The combined use of PROs and CTCAE data makes particular sense for AEs/aspects that are directly experienced by the patient (fatigue, pain, cognitive problems, emotional functioning, ...) and can only be adequately recorded by the clinician through communication with the patient.

Evaluating the Use of Patient-Reported Outcome Measures for Improving the Inter-Rater Reliability of Common Terminology Criteria for Adverse Event Ratings

physician 1 rates patient symptoms (17 CTCAE domains matching the EORTC C30 and additional questions)

physician 2 rates patient symptoms (17 CTCAE domains matching the EORTC C30 and additional questions)

Bezirkskrankenhaus Kufstein

Centre Hospitalier Universitaire de Besancon

Martin-Luther-Universität Halle-Wittenberg

Università di Cagliari

Kansai Medical University

King Hussein Cancer Center

Tata Memorial Hospital

Rigshospitalet, Denmark

King's College

Clinical Hospital Center Rijeka

Medical University Innsbruck

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Paclitaxel

Carboplatin

Pemetrexed

Albumin-Bound Paclitaxel

Nivolumab

Veliparib

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Poly(ADP-ribose) Polymerase Inhibitors

Folinic Acid

Folate

Vitamin B9

Veliparib and nivolumab in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed)

Veliparib in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed)

intravenous; administered on Day 1 via infusion in a 21-day cycle

pemetrexed

nivolumab

paclitaxel

oral capsule; varying doses administered on Days -2 to 5 in a 21-day cycle

veliparib

carboplatin

AbbVie Inc.

This study seeks to establish the recommended Phase 2 dose (RPTD) of veliparib in combination with nivolumab and platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed) (Phase 1 portion) and to assess whether the addition of nivolumab to veliparib in combination with platinum doublet chemotherapy results will improve progression free survival (PFS) compared to veliparib with platinum doublet chemotherapy alone in participants with metastatic or advanced Non-small Cell Lung Cancer (NSCLC) (Phase 2 portion).

A strategy decision was made not to proceed to Phase 2 portion of this study due to change in standard of care.

Study of Veliparib in Combination With Nivolumab and Platinum Doublet Chemotherapy in Participants With Metastatic or Advanced Non-Small Cell Lung Cancer (NSCLC)

A Phase 1 Dose-Escalation and Phase 2 Randomized, Open-Label Study of Nivolumab and Veliparib in Combination With Platinum Doublet Chemotherapy in Subjects With Metastatic or Advanced Non-Small Cell Lung Cancer (NSCLC)

PFS is defined as the number of days from the date of randomization to the date of earliest disease progression (radiographic progression per RECIST version 1.1 or clinical disease progression) or death. If the participant does not experience disease progression or death, then the data will be censored at the date of the last disease assessment.

OS is defined as the number of days from the date of randomization to the date of death. For subjects who did not die, their data will be censored at the date of last study visit or the last known date to be alive, whichever is later.

DOR is defined as the number of days from the date of first response (CR or PR) to the earliest documentation of progressive disease or death due to disease progression.

ORR is defined as the proportion of the participants who have a complete response (CR) or partial response (PR).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluating the Use of Patient-Reported Outcome Measures for Improving the Inter-Rater Reliability of Common Terminology Criteria for Adverse Event Ratings	NCT04066868	Cancer	Patient-reporte... CTCAE rating PRO data is dis...	18 Years -	Medical University Innsbruck
Study of Veliparib in Combination With Nivolumab and Platinum Doublet Chemotherapy in Participants With Metastatic or Advanced Non-Small Cell Lung Cancer (NSCLC)	NCT02944396	Non-Small Cell ...	pemetrexed nivolumab paclitaxel veliparib carboplatin	18 Years -	AbbVie

Spots Global Cancer Trial Database for common terminology criteria for adverse events (ctcae)