SWOG clinical trial number
S1013

A Phase II Prospective Study of Epidermal Growth Factor Receptor (Her-1/EGFR) Inhibitor-Induced Dermatologic Toxicity: Validation of the Functional Assessment of Cancer Therapy � EGFRI 18 (FACT-EGFRI 18) Questionnaire for EGFRI-induced Skin Toxicities

Closed
Phase
Accrual
94%
Abbreviated Title
EGFR Skin Toxicity Validation
Status Notes
This study will be permanently closed to accrual on October 1, 2016, at 11:59 p.m. Pacific.
Activated
11/15/2011
Closed
10/01/2016
Participants
Limited: Institutions Listed on the Title Page

Research committees

Symptom Control and Quality of Life
Gastrointestinal Cancer
Lung Cancer

Eligibility Criteria Expand/Collapse

Colorectal or lung cancer patients planning to receive one of the following HER1/EGFR inhibitor therapies for at least 6 weeks: cetuximab 400mg/m2 loading dose and 250mg/m2 weekly, cetuximab 500mg/m2 every 2 weeks, Panitumumab 6mg/kg every 2 weeks, or erlotinib 100-150mg daily; prior HER1/EGFR inhibitor therapy allowed if all skin toxicities are resolved; no serious concomitant skin disorders (atopic dermatitis, contact dermatitis, psoriasis, rosacea, severe photosensitivity, scleroderma, steroid-induced acne, xerosis); must not receive concomitant medications that can cause skin rash or other dermatologic reactions; Zubrod PS of 0-2; able to complete questionnaires in English; not planning to receive concurrent external bean radiation therapy; concurrent participation in other therapeutic clinical trials is allowed; able to complete baseline S1013 FACT-EGFRI 18 within 3 days prior to initiations of EGFRI therapy.

Publication Information Expand/Collapse

2020

A prospective study to validate the functional assessment of cancer therapy (FACT) for epidermal growth factor receptor inhibitor (EGFRI)-induced dermatologic toxicities FACT-EGFRI 18 questionnaire: SWOG S1013

S-F Wong;JM Unger;JL Wade;L Wagner;M Lacouture;K Humphries;A Moseley;K Arnold;M Velasco;J Floyd;B Esparaz;A Barzi;H-J Lenz;M Koczywas;S Dakhil;GV Burton;MJ Fisch;NL Henry;DL Hershman;CM Moinpour Journal of Patient Reported Outcomes Jul 8;4(1):54

PMid: PMID32642992 | PMC number: PMC7343679