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Colorectal CancerNCT01416688

S1013: Validation of Cancer Questionnaire for Skin Toxicities in Patients With Colorectal Cancer or Lung Cancer Receiving Cetuximab, Panitumumab, or Erlotinib Hydrochloride

An observational study of Colorectal Cancer and Dermatologic Complications, run by SWOG Cancer Research Network at 113 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Questionnaires that patients can use to assess skin toxicities related to treatment may help identify the intermediate-and long-term effects of cetuximab, panitumumab, or erlotinib hydrochloride. Read more about this study

Who is it for?
Ages 18 to 120 years
What is being tested?
assessment of therapy complications, psychosocial assessment and care and quality-of-life assessment
Type of treatment
Surgery or procedure
How many people
146 participants
Where
113 sitesUnited States
Study dates
15 Nov 2011to 8 Apr 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Limited institutions from the SWOG membership.

DISEASE CHARACTERISTICS:

  • Patients must have a diagnosis of colorectal or lung cancer and be planning to receive one of the following epidermal growth factor receptor (HER1/EGFR) inhibitor therapies listed below for at least 6 weeks:
  • Cetuximab 400 mg/m² loading dose, 250 mg/m² weekly
  • Cetuximab 500 mg/m² every 2 weeks
  • Panitumumab 6 mg/kg every 2 weeks
  • Erlotinib hydrochloride 100-150 mg daily
  • Other HER1/EGFR inhibitor therapies, schedules, or doses of the above listed agents are not allowed
  • Concurrent chemotherapy and other anti-cancer therapies (such as carboplatin, paclitaxel, and bevacizumab) are allowed EXCEPT for the following chemotherapeutic agents that are known to cause skin rash that could interfere with EGFRI-induced skin toxicity assessment: gemcitabine, capecitabine, and topical fluorouracil (Efudex™, Fluoroplex™, Carac™)
  • Patients must have completed the baseline S1013 Functional Assessment of Cancer Therapy- (FACT) EGFRI 18 within 7 days prior to registration

PATIENT CHARACTERISTICS:

  • Patients must have a Zubrod performance status of 0-2
  • Patients must not have any of the following serious concomitant skin disorders that, in the investigator's opinion, could interfere with assessment of epidermal growth factor receptor inhibitor (EGFRI)-induced skin toxicity: atopic dermatitis [eczema]; contact dermatitis; psoriasis; rosacea; severe photosensitivity; scleroderma; steroid-induced acne; or xerosis
  • Patients must be able to complete questionnaires in English

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Patients may have had prior epidermal growth factor receptor (HER1/EGFR) inhibitor therapy but must have fully recovered from any skin toxicities prior to registration
  • Patients must not be planning to receive any of the following concomitant medications that can cause skin rash or other dermatologic reactions that could interfere with the EGFRI-induced skin toxicity assessments, for the duration of the study: allopurinol; systemic corticosteroids; topical retinoids (Retin-A™, Tretinoin™); or oral retinoids (Amnesteem™, Claravis™, Sotret™)
  • Patients must not be planning to receive concurrent external-beam radiation therapy, including prophylactic cranial radiation
  • Patients may concurrently participate in other therapeutic clinical trials

Trial locations and contacts

113 sites in 1 country.

113 sites in 1 country

United States113 sites

  • Cancer Care of Western North Carolina

    Asheville, North Carolina, 28801

  • Mission Hospital-Memorial Campus

    Asheville, North Carolina, 28801

  • Hope Women's Cancer Centers-Asheville

    Asheville, North Carolina, 28816

  • Saint Joseph Medical Center

    Bloomington, Illinois, 61701

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Parkland Health Center-Bonne Terre

    Bonne Terre, Missouri, 63628

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Southeast Cancer Center

    Cape Girardeau, Missouri, 63703

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • East Bay Radiation Oncology Center

    Castro Valley, California, 94546

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • Southeastern Medical Oncology Center-Clinton

    Clinton, North Carolina, 28328

  • Carolinas HealthCare System NorthEast

    Concord, North Carolina, 28025

  • Cancer Care Center of Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Heartland Cancer Research NCORP

    Decatur, Illinois, 62526

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Epic Care-Dublin

    Dublin, California, 94568

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Bay Area Breast Surgeons Inc

    Emeryville, California, 94608

  • Epic Care Partners in Cancer Care

    Emeryville, California, 94608

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • Little Company of Mary Hospital

    Evergreen Park, Illinois, 60805

  • McLaren Cancer Institute-Flint

    Flint, Michigan, 48532

  • Singh and Arora Hematology Oncology PC

    Flint, Michigan, 48532

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • Southeastern Medical Oncology Center-Goldsboro

    Goldsboro, North Carolina, 27534

  • Wayne Memorial Hospital

    Goldsboro, North Carolina, 27534

  • Hendersonville Hematology and Oncology at Pardee

    Hendersonville, North Carolina, 28791

  • Margaret R Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • High Point Regional Hospital

    High Point, North Carolina, 27261

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Centerpoint Medical Center LLC

    Independence, Missouri, 64057

  • Southeastern Medical Oncology Center-Jacksonville

    Jacksonville, North Carolina, 28546

  • Capital Region Medical Center-Goldschmidt Cancer Center

    Jefferson City, Missouri, 65109

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Heartland Hematology and Oncology Associates Incorporated

    Kansas City, Missouri, 64118

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • McLaren Cancer Institute-Lapeer Region

    Lapeer, Michigan, 48446

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Saint Luke's East - Lee's Summit

    Lee's Summit, Missouri, 64086

  • Cancer Center of Kansas-Liberal

    Liberal, Kansas, 67905

  • Liberty Radiation Oncology Center

    Liberty, Missouri, 64068

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Los Angeles County-USC Medical Center

    Los Angeles, California, 90033

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • Cancer Center of Kansas-Manhattan

    Manhattan, Kansas, 66502

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156

  • Cancer Center of Kansas - McPherson

    McPherson, Kansas, 67460

  • Winthrop University Hospital

    Mineola, New York, 11501

  • University Health-Conway

    Monroe, Louisiana, 71202

  • Carolinas HealthCare System Union

    Monroe, North Carolina, 28112

  • McLaren Cancer Institute-Macomb

    Mount Clemens, Michigan, 48043

  • El Camino Hospital

    Mountain View, California, 94040

  • Columbia University/Herbert Irving Cancer Center

    New York, New York, 10032

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • Highland General Hospital

    Oakland, California, 94602

  • Alta Bates Summit Medical Center - Summit Campus

    Oakland, California, 94609

  • Bay Area Tumor Institute

    Oakland, California, 94609

  • Hematology and Oncology Associates-Oakland

    Oakland, California, 94609

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • Radiation Oncology of Northern Illinois

    Ottawa, Illinois, 61350

  • Menorah Medical Center

    Overland Park, Kansas, 66209

  • Saint Luke's South Hospital

    Overland Park, Kansas, 66213

  • Cancer Center of Kansas - Parsons

    Parsons, Kansas, 67357

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

  • OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

    Pekin, Illinois, 61554

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61603

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • OSF Saint Francis Radiation Oncology at Peoria Cancer Center

    Peoria, Illinois, 61615

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

  • Valley Radiation Oncology

    Peru, Illinois, 61354

  • McLaren Cancer Institute-Northern Michigan

    Petoskey, Michigan, 49770

  • Cancer Center of Kansas - Pratt

    Pratt, Kansas, 67124

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • Sainte Genevieve County Memorial Hospital

    Sainte Genevieve, Missouri, 63670

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67401

  • Doctors Medical Center- JC Robinson Regional Cancer Center

    San Pablo, California, 94806

  • Carolinas HealthCare System Cleveland

    Shelby, North Carolina, 28150

  • Louisiana State University Health Sciences Center Shreveport

    Shreveport, Louisiana, 71103

  • Central Illinois Hematology Oncology Center

    Springfield, Illinois, 62702

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Springfield Clinic

    Springfield, Illinois, 62703

  • Memorial Medical Center

    Springfield, Illinois, 62781

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Missouri Baptist Sullivan Hospital

    Sullivan, Missouri, 63080

  • Missouri Baptist Outpatient Center-Sunset Hills

    Sunset Hills, Missouri, 63127

  • Cancer Care Specialists of Illinois-Swansea

    Swansea, Illinois, 62226

  • University of Arizona Cancer Center-North Campus

    Tucson, Arizona, 85719

  • The University of Arizona Medical Center-University Campus

    Tucson, Arizona, 85724

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • Associates In Womens Health

    Wichita, Kansas, 67208

  • Cancer Center of Kansas-Wichita Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas - Wichita

    Wichita, Kansas, 67214

  • Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Wichita NCI Community Oncology Research Program

    Wichita, Kansas, 67214

  • Southeastern Medical Oncology Center-Wilson

    Wilson, North Carolina, 27893

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas, 67156

  • Southeast Clinical Oncology Research (SCOR) Consortium NCORP

    Winston-Salem, North Carolina, 27104

Other trials in United States

About this study

Official title: S1013: A 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

RATIONALE: Questionnaires that patients can use to assess skin toxicities related to treatment may help identify the intermediate-and long-term effects of cetuximab, panitumumab, or erlotinib hydrochloride.

PURPOSE: This trial studies the validation of a cancer questionnaire for skin toxicities in patients with colorectal or lung cancer receiving cetuximab, panitumumab, or erlotinib hydrochloride.

Read the detailed description

OBJECTIVES:

Primary

  • To establish psychometric properties for the Functional Assessment of Cancer Therapy Epidermal Growth Factor Receptor Inhibitor (FACT-EGFRI 18) module (based on criterion validity, known group's validity, internal consistency reliability, and responsiveness to change) as a patient-reported outcome (PRO) measure of EGFRI-induced skin-related toxicity.

Secondary

  • To document minimally important differences over time for the FACT-EGFRI 18 by comparing mean changes in this PRO measure to the patient's direct assessment of change using two anchor items (change in skin condition severity and impact).
  • To examine the association between toxicity profiles (severity and time to onset), and treatment profiles (e.g., delays and discontinuation) and the FACT-EGFRI 18 scores.
  • To assess degree of concordance between FACT-EGFRI 18 ratings and study site physician CTCAE Version 4.0 EGFRI-Induced Dermatologic Toxicity Grading Assessment ratings.
  • To evaluate feasibility outcomes.

OUTLINE: This is a multicenter study.

Patients complete the S1013 Functional Assessment of Cancer Therapy Epidermal Growth Factor Receptor Inhibitor (FACT-EGFRI 18) at baseline and prior to beginning therapy and clinical assessment. Patients also complete FACT-EGFRI 18 and the Changes in Skin Symptoms on days 1*, 8**, 15, 22, 29, 36, 43, 71, 99, and 127. Patients who do not develop any grade of papulopustular rash within 42 days are removed from study.

Investigators performing the patients' clinical assessment complete the EGFRI-Induced Dermatologic Toxicity Grading Assessment on days 1, 8, 15, 22, 29, 36, 43, 71, 99, and 127, and the Treatment Form assessment on days 22, 43, 71, 99, and 127. Nurses or clinical trial administrators (CRA) also complete the S1013 Cover Sheet for Patient Complete Questionnaires accompanying the FACT-EGFRI 18 patients' questionnaires at each schedule assessment.

NOTE: *Patients start EGFRI therapy.

NOTE: **Change in Skin Symptoms questionnaire starts on Day 8.

Being tested
assessment of therapy complications, psychosocial assessment and care, quality-of-life assessment
Keywords
therapy-related toxicity, dermatologic complications, stage I colon cancer, stage IIA colon cancer, stage IIB colon cancer, stage IIC colon cancer, stage IIIA colon cancer, stage IIIB colon cancer, stage IIIC colon cancer, stage IVA colon cancer, stage IVB colon cancer, stage I rectal cancer, stage IIA rectal cancer, stage IIB rectal cancer, stage IIC rectal cancer, stage IIIA rectal cancer, stage IIIB rectal cancer, stage IIIC rectal cancer, stage IVA rectal cancer, stage IVB rectal cancer
Medical subject headings
Colorectal Neoplasms, Lung Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • assessment of therapy complicationsProcedure or surgery

    Will be given by questionnaire

  • psychosocial assessment and careProcedure or surgery

    Will be given by questionnaire

  • quality-of-life assessmentProcedure or surgery

    Will be given by questionnaire

Study groups in NCT01416688
Study groupRoleWhat they receive
Observation and QuestionnairesPatients will be given questionnaires for the assessment of therapy complications, psychosocial assessment and care, and quality-of-life assessment.
Receives: Procedure: assessment of therapy complications; Procedure: psychosocial assessment and care; Procedure: quality-of-life assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Psychometric properties of the FACT-EGFRI 18

    Measured: 127 days from registration

Secondary outcomes (4)

  1. Change in severity and impact of skin symptoms

    Measured: 127 days from registration

  2. Agreement between site physician ratings with the CTCAE Version 4 and patient ratings for the FACT-EGFRI 18 items

    Measured: 127 days from registration

  3. Associations between toxicity profile and treatment profiles

    Measured: 127 days from registration

  4. Feasibility as measured by accrual, time to specified accrual, time to complete forms

    Measured: 2 years from study activation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2011 (estimated)
  2. Study start15 Nov 2011
  3. Primary completion1 May 2018
  4. Study completion8 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01416688
Sponsor's protocol ID
S1013
Other IDs
S1013, U10CA037429, NCI-2011-02983
Status last verified
Dec 2022
First submitted
12 Aug 2011
Last updated
15 Dec 2022
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer and Dermatologic Complications, run by SWOG Cancer Research Network at 113 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 113 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Psychometric properties of the FACT-EGFRI 18 (time frame: 127 days from registration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01416688.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.

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