Clinical effectiveness and side effects of different treatment methods for lung cancer
| ISRCTN | ISRCTN14796973 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14796973 |
- Submission date
- 11/10/2022
- Registration date
- 22/10/2022
- Last edited
- 20/04/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
The aim of this study is to assess the clinical effectiveness and side effects of different treatments for lung adenocarcinoma (the most common type of lung cancer).
Who can participate?
Late-stage lung adenocarcinoma patients admitted to the oncology department
What does the study involve?
Patients are separated into four different groups according to their gene mutation status. The four groups are treated with targeted drugs or targeted drugs combined with chemotherapy. The difference in recent treatment effects and the occurrence of adverse reactions in the seven groups are compared. Every chemotherapy cycle lasts 3 weeks. Four to six cycles are given depending on the patient's recovery and tolerance. Patients stopped taking the medication when they could not tolerate the side effects or the disease progressed.
What are the possible benefits and risks of participating?
The patients are treated professionally for their disease. There are no risks of participating.
Where is the study run from?
Fujian Provincial Hospital (China)
When is the study starting and how long is it expected to run for?
January 2017 to October 2020
Who is funding the study?
Tianqing Medical Science Development Fundl (China)
Who is the main contact?
Ting Li, fjslzjp@163.com
Contact information
Public
Department of Oncology
Shengli Clinical Medical College of Fujian Medical University
Fujian Provincial Hospital
Fuzhou
350001
China
| Phone | +86 (0)15711393692 |
|---|---|
| fjslzjp@sina.com |
Study information
| Study design | Single-center observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Observation on the clinical efficacy and side effects of EGFR-TKI ± chemotherapy in the treatment of EGFR mutation-positive advanced lung adenocarcinoma |
| Study objectives | To assess the clinical efficacy and side effects of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) with or without chemotherapy in the treatment of EGFR mutation-positive advanced lung adenocarcinoma. |
| Ethics approval(s) | Approved 26/11/2021, Fujian Provincial Hospital Ethics Committee (Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, No.134 East Street, Fuzhou, Fujian 350001, China; +86 (0)591 87557768; fjslec@163.com), ref: NUMBER/ID:K2021-11-010 |
| Health condition(s) or problem(s) studied | EGFR mutation-positive advanced lung adenocarcinoma |
| Intervention | 103 EGFR mutation-positive stage IIIB or IV lung adenocarcinoma patients were enrolled in the department of oncology of Fujian Provincial Hospital from January 2017 to October 2020. According to gene mutation status, 103 EGFR-sensitive mutation patients were separated into four different groups: 19del alone, 19del combined with TP53 or other co-mutations, L858R alone, and L858R mutation combined with TP53 or other co-mutations. The four groups were respectively treated with targeted drugs or targeted drugs combined with chemotherapy. In the 19del alone group only targeted drugs were used and no chemotherapy was applied. The difference in recent treatment effects and the occurrence of adverse reactions in the seven groups were compared. Chemotherapy regimen: pemetrexed disodium 500 mg/ m2D1 cisplatin 25 mg/ m2D1-3 or carboplatin AUC5 were given intravenously. Every chemotherapy cycle lasted 3 weeks. Four to six cycles were given depending on the patient's recovery and tolerance. Targeted drug therapy: oral gefitinib tablets (Iressa, national drug approval J20180014, AstraZeneca Pharmaceutical Co., Ltd) 250 mg/day, once a day, patients took it orally until the end of follow-up. Patients stopped taking the medication when they could not tolerate the side effects or the disease progressed. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Pemetrexed disodium, cisplatin, carboplatin, gefitinib |
| Primary outcome measure | 1. Long-term efficacy: tumor progression-free survival (PFS) and survival calculated from enrollment to 1-year and 3-year follow-up 2. Adverse effects: the occurrence and severity of adverse events, including acute central nervous system adverse reactions, acute radiation pneumonia, vomiting, nausea, rash, diarrhea, liver function damage, and bone marrow suppression, using the commonly used term evaluation criterion (CTCAE4.0) of the National Cancer Center of Adverse Events and the tumor radiotherapy group (RTOG) classification standard. Calculated at 1-year and 3-year follow-up |
| Secondary outcome measures | 1. Size and metastasis of the target tumor determined using head MRI, chest and abdomen CT (including adrenal gland), bone X-ray or MRI, or whole body PET-CT and other examinations before treatment and 12 weeks after treatment 2. Short-term efficacy: According to the WHO criteria for evaluation of solid tumor efficacy (RECIST1.1), patients were separated into progressive response (PD), stable response (SD), partial response (PR) and complete response (CR) groups. CR: indicated that all lymph nodes had shrunk to less than 10 mm and all visible lesions were cleared and maintained for at least a month; PR: the sum of the maximum diameters of all target tumors was reduced by more than 30% from baseline and remained stable for at least a month; PD: signifies that there is more than 20% growth in the sum of all target tumor maximum diameters from the minimum, and there are at least 5 mm increases in the absolute value of the maximum diameters, or that one or more new lesions emerge; SD stands for the status between PR and PD. ORR= (CR+PR)/total number of cases ×100%. |
| Overall study start date | 01/01/2017 |
| Completion date | 01/10/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 80 |
| Total final enrolment | 103 |
| Key inclusion criteria | 1. Initial treatment of lung adenocarcinoma confirmed by pathology or cytology 2. Classic mutation of EGFR gene 3. Minimum life expectancy 3 months 4. Patients with clinical stage III ~ IV were considered as advanced lung cancer after comprehensive evaluation of imaging, medical history and examination at the same time, and were excluded from other malignant tumors |
| Key exclusion criteria | Does not meet the inclusion criteria |
| Date of first enrolment | 01/01/2017 |
| Date of final enrolment | 01/09/2020 |
Locations
Countries of recruitment
- China
Study participating centre
Fuzhou
350001
China
Sponsor information
Hospital/treatment centre
No.134 East Street
Fuzhou
350001
China
| Phone | +86 (0)591 87557768 |
|---|---|
| unionqyye@163.com | |
| Website | http://www.fjsl.com.cn/ |
"ROR" |
https://ror.org/045wzwx52 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 30/11/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | Raw data can be obtained by contacting Ting Li (fjslzjp@163.com). The type of data: Patients’ information in Excel format. Duration: Forever available. The data will be shared with researchers who also study lung cancer, for dataset analysis, using statistical methods. Consent from participants was obtained. Data were anonymized. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 12/12/2022 | 20/04/2023 | Yes | No |
Editorial Notes
20/04/2023: Publication reference added.
19/10/2022: Trial's existence confirmed by the Fujian Provincial Hospital Ethics Committee.
