Non-small Cell Lung CancerPhase 2/3NCT02284139
Pilot Trial of EGF Ointment for the Patients With EGFR-i Related Skin Side Effects
A Phase 2/3 study testing Arm EGF ointment 1ppm and Arm EGF ointment 20 ppm in people with Non-small Cell Lung Cancer and Pancreatic Cancer, run by Dong-A University Hospital at 1 site in South Korea.
Trial summary
The efficacy of the epidermal growth factor receptor (EGFR) inhibitors have been demonstrated in patients with non-small cell lung cancer (NSCLC), pancreatic cancer (PC) and colorectal cancer (CRC). Dermatological reactions can cause significant physical and psycho-social discomfort to patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer
- What is being tested?
- Arm EGF ointment 1ppm and Arm EGF ointment 20 ppm
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2015to Dec 2017
- Phase
- Phase 2/3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: older than 20
- Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
- Histologically confirmed lung cancer, pancreatic cancer, or colon cancer
- Patients take EGFR inhibitor following the reason
- EGFR mutation (+) NSCLC - adenocarcinoma for 1st line treatment
- NSCLC - for ≥ 2nd line treatment
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- Pancreatic cancer - adenocarcinoma for 1st line treatment with Gemcitabine
- Colon cancer - adenocarcinoma 1st line treatment with Irinotecan (FOLFIRI)
- Patients who have EGFR inhibitor related skin side effects (ERSE) Gr≥2 (NCICTC V4.0)
- A patient with the willingness to comply with the study protocol during the study period and capable of complying with it
- A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages
Who cannot join
- A patient with previous active or passive immunotherapy
- A pregnant or lactating patient
- A patient of childbearing potential without being tested for pregnancy at baseline for positive. (A postmenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential.)
- A patient with history of uncontrolled seizures, central nervous system disorder or psychiatric disorders that are considered clinically significant by the investigator that would prohibit the understanding of informed consent or that may be considered to interfere with the compliance of the administration of the study medications
- A patient with history of dermatologic care (except transient urticaria) within 4 weeks
- A patient with clinically significant (i.e. active) heart disease (e.g. congestive heart failure, symptomatic coronary artery diseases, cardiac arrhythmias, etc) or myocardial infarction within past 12 months
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- A patient with interstitial pneumonia or diffused symptomatic fibrosis of the lungs.
- Organ allogenic transplantation requiring immunosuppressive therapy. Any waiver of these inclusion and exclusion criteria must be approved by the investigator and the sponsor on a case-by case basis prior to enrolling the subject
- Known allergies, hypersensitivity, or intolerance to study drugs, chemotherapy drugs using this clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Trial of Epidermal Growth Factor (EGF) Ointment for the Patients With Epidermal Growth Factor Receptor (EGFR) Inhibitor Related Skin Side Effects
The efficacy of the epidermal growth factor receptor (EGFR) inhibitors have been demonstrated in patients with non-small cell lung cancer (NSCLC), pancreatic cancer (PC) and colorectal cancer (CRC). Dermatological reactions can cause significant physical and psycho-social discomfort to patients. In the present study, the investigators evaluated the effect of epidermal growth factor (EGF) ointment on EGFR inhibitor-related skin side effects (ERSEs).
Read the detailed description
The current study includes patients diagnosed with advanced NSCLC or PC or CRC, with pathological confirmation. The inclusion criteria were NSCLC treated with erlotinib alone and PC treated with gemcitabine and erlotinib combination chemotherapy and CRC treated with cetuximab and5-Fluorouracil (5-FU)+Irinotecan+leucovorin(LV) (FOLFIRI), 5-FU+Oxaliplatin+LV (FOLFOX) and sufficient liver, kidney, and bone marrow function to undergo treatment. All the patients had Grade ≥2 ERSEs according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) v. 4.03.
The patients will be randomized 3 groups; Placebo group, Arm 1, and Arm 2. Arm 1 will be treated with 1ppm concentration EGF ointment. Arm 2 will be treated with 20ppm concentration EGF ointment. And placebo group will be treated with 0ppm concentration EGF ointment.
- Being tested
- Arm EGF ointment 1ppm, Arm EGF ointment 20 ppm, Arm Placebos
- Keywords
- EGF ointment, EGFR inhibitor, Skin side effect
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm EGF ointment 1ppmDrug
Also called Saesal yeongo 1 (EGF ointment 1ppm)
EGF Ointment 1ppm evenly apply to skin lesion every 12 hr/ day
Arm EGF ointment 20 ppmDrug
Also called Saesal yeongo 20 (EGF ointment 20 ppm)
EGF Ointment 20 evenly apply to skin lesion every 12 hr/ day
Arm PlacebosDrug
Also called Saesal yeongo 0 (EGF ointment 0 ppm)
EGF Ointment 0ppm evenly apply to skin lesion every 12 hr/ day
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo ointment dose not contain EGF. Receives: Drug: Arm Placebos |
| Arm EGF ointment 1ppm | Active comparator | Arm EGF ointment 1ppm will be treated with EGF ointment of 1 ppm concentration Receives: Drug: Arm EGF ointment 1ppm |
| Arm EGF ointment 20ppm | Active comparator | Arm EGF ointment 20ppm will be treated with EGF ointment of 20 ppm concentration Receives: Drug: Arm EGF ointment 20 ppm |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the response rate of EGF ointment
The effectiveness of the EGF ointment was defined as follows:
- Grade 2, 3, or 4 ERSEs downgraded to ≤Grade 1 or
- Grade 3 or 4 ERSEs downgraded to Grade 2 and persisting for at least two weeks.
Measured: 1 year
Secondary outcomes (1)
Quality of Life
To evaluate the patients' Quality of Life (QoL) by Skin evaluation method (SKINDEX-16)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study startApr 2015
- Primary completionDec 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung Yong Oh, Dong-A University Hospital
- Investigators
- SUNG YONG OH, M.D., Principal investigator, Dong-A University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284139
- Sponsor's protocol ID
- DAUH-14-211
- Status last verified
- Apr 2018
- First submitted
- 3 Nov 2014
- Last updated
- 23 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim YS, Ji JH, Oh SY, Lee S, Huh SJ, Lee JH, Song KH, Son CH, Roh MS, Lee GW, Lee J, Kim ST, Kim CK, Jang JS, Hwang IG, Ahn HK, Park LC, Oh SY, Kim SG, Lee SC, Lim DH, Lee SI, Kang JH. A Randomized Controlled Trial of Epidermal Growth Factor Ointment for Treating Epidermal Growth Factor Receptor Inhibitor-Induced Skin Toxicities. Oncologist. 2020 Jan;25(1):e186-e193. doi: 10.1634/theoncologist.2019-0221. Epub 2019 Sep 6.
PubMed 31492766
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Epidermal Growth Factor (EGF) Ointment for the Patients With Epidermal Growth Factor Receptor (EGFR) Inhibitor Related Skin Side Effects
- ClinicalTrials.gov ID
- NCT02284139
- Acronym / sponsor ID
- DAUH-14-211
- Keywords
- EGF ointment, EGFR inhibitor, Skin side effect
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Dong-A University HospitalUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 5 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The efficacy of the epidermal growth factor receptor (EGFR) inhibitors have been demonstrated in patients with non-small cell lung cancer (NSCLC), pancreatic cancer (PC) and colorectal cancer (CRC). Dermatological reactions can cause significant physical and psycho-social discomfort to patients. In the present study, the investigators evaluated the effect of epidermal growth factor (EGF) ointment on EGFR inhibitor-related skin side effects (ERSEs).
Detailed description
The current study includes patients diagnosed with advanced NSCLC or PC or CRC, with pathological confirmation. The inclusion criteria were NSCLC treated with erlotinib alone and PC treated with gemcitabine and erlotinib combination chemotherapy and CRC treated with cetuximab and5-Fluorouracil (5-FU)+Irinotecan+leucovorin(LV) (FOLFIRI), 5-FU+Oxaliplatin+LV (FOLFOX) and sufficient liver, kidney, and bone marrow function to undergo treatment. All the patients had Grade ≥2 ERSEs according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) v. 4.03.
The patients will be randomized 3 groups; Placebo group, Arm 1, and Arm 2. Arm 1 will be treated with 1ppm concentration EGF ointment. Arm 2 will be treated with 20ppm concentration EGF ointment. And placebo group will be treated with 0ppm concentration EGF ointment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Arm PlacebosPlacebo ointment dose not contain EGF. |
| Arm EGF ointment 1ppm | Active comparator | Drug: Arm EGF ointment 1ppmArm EGF ointment 1ppm will be treated with EGF ointment of 1 ppm concentration |
| Arm EGF ointment 20ppm | Active comparator | Drug: Arm EGF ointment 20 ppmArm EGF ointment 20ppm will be treated with EGF ointment of 20 ppm concentration |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age: older than 20
- Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
- Histologically confirmed lung cancer, pancreatic cancer, or colon cancer
- Patients take EGFR inhibitor following the reason
- Patients who have EGFR inhibitor related skin side effects (ERSE) Gr≥2 (NCICTC V4.0)
Key exclusion criteria (9 listed)
- A patient with previous active or passive immunotherapy
- A pregnant or lactating patient
- A patient of childbearing potential without being tested for pregnancy at baseline for positive. (A postmenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential.)
- A patient with history of uncontrolled seizures, central nervous system disorder or psychiatric disorders that are considered clinically significant by the investigator that would prohibit the understanding of informed consent or that may be considered to interfere with the compliance of the administration of the study medications
- A patient with history of dermatologic care (except transient urticaria) within 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm EGF ointment 1ppmAlso: Saesal yeongo 1 (EGF ointment 1ppm)EGF Ointment 1ppm evenly apply to skin lesion every 12 hr/ day | Drug | Arm EGF ointment 1ppm |
| Arm EGF ointment 20 ppmAlso: Saesal yeongo 20 (EGF ointment 20 ppm)EGF Ointment 20 evenly apply to skin lesion every 12 hr/ day | Drug | Arm EGF ointment 20ppm |
| Arm PlacebosAlso: Saesal yeongo 0 (EGF ointment 0 ppm)EGF Ointment 0ppm evenly apply to skin lesion every 12 hr/ day | Drug | Placebo |
Primary outcome
To estimate the response rate of EGF ointment
Time frame: 1 year
The effectiveness of the EGF ointment was defined as follows: 1. Grade 2, 3, or 4 ERSEs downgraded to ≤Grade 1 or 2. Grade 3 or 4 ERSEs downgraded to Grade 2 and persisting for at least two weeks.
1 secondary outcome
Quality of Life
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
- Derived from this study: PubMed 31492766Kim YS, Ji JH, Oh SY, Lee S, Huh SJ, Lee JH, Song KH, Son CH, Roh MS, Lee GW, Lee J, Kim ST, Kim CK, Jang JS, Hwang IG, Ahn HK, Park LC, Oh SY, Kim SG, Lee SC, Lim DH, Lee SI, Kang JH. A Randomized Controlled Trial of Epidermal Growth Factor Ointment for Treating Epidermal Growth Factor Receptor Inhibitor-Induced Skin Toxicities. Oncologist. 2020 Jan;25(1):e186-e193. doi: 10.1634/theoncologist.2019-0221. Epub 2019 Sep 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SUNG YONG OH, M.D. principal investigator
Dong-A University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Arm EGF ointment 1ppm and Arm EGF ointment 20 ppm in people with Non-small Cell Lung Cancer and Pancreatic Cancer, run by Dong-A University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. 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 23 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To estimate the response rate of EGF ointment (time frame: 1 year). 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 NCT02284139, which also lists 1 linked publication.
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 23 Apr 2018.