QOL; Quality of Life;Gastric Cancer; Gastrectomy;Neoadjuvant ChemotherapyNCT04408859
Quality of Life in Advanced Gastric Cancer Patients Receiving Neoadjuvant Chemotherapy
An observational study of QOL; Quality of Life;Gastric Cancer; Gastrectomy;Neoadjuvant Chemotherapy, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
The purpose of this study is to explore the influence of neoadjuvant chemotherapy in the long term quality of life with advanced gastric cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- QOL; Quality of Life;Gastric Cancer; Gastrectomy;Neoadjuvant Chemotherapy
- What is being tested?
- Neoadjuvant Chemotherapy
- How many people
- 290 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2018to 10 Jan 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have had curative resection at Beijing Cancer Hospital for advanced gastric cancer and finish the questionnaire.
Who may be able to join
- Patients age older than 18 years (including 18 years old);
- Diagnosis of adenocarcinoma of the stomach
- The clinic stage is ≥T2 and any N stage
- Patient had curative surgical resection, including proximal, distal, or total gastrectomy
Who cannot join
- Psychiatric or psychological abnormality precluding informed consent or ability to complete questionnaires
- Non-psychiatric disorder causing a lack of capacity to give consent or an inability to complete questionnaires (ie dementia, stroke)
- Early gastric cancer.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100010
Zaozao Wang, 0086-10-88196851, zaozao83630@sina.com
Jianhong Yu, 0086-10-88196851, yjh1911110624@peu.edu.cn
About this study
Official title: Quality of Life in Patient With Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery Alone for Locally Advanced Gastric Cancer
The purpose of this study is to explore the influence of neoadjuvant chemotherapy in the long term quality of life with advanced gastric cancer patients.
Read the detailed description
Preoperative adjuvant chemotherapy combined with postoperative adjuvant therapy mode was included in the 2018 version of the National Comprehensive Cancer Network (NCCN) guideline as an optional treatment (category 2B) for prospective resectable advanced gastric cancer cases (≥cT2, any N).At home and abroad, the research on neoadjuvant chemotherapy for advanced gastric cancer mainly focuses on the safety and long-term survival, and there are few studies on the quality of life. This study, according to EORTC QLQ-C30 and QLQ-STO22 assessment scale, explores the long term effect of neoadjuvant chemotherapy on the quality of life in patients with advanced gastric cancer.
- Being tested
- Neoadjuvant Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant ChemotherapyDrug
The patients receive neoadjuvant chemotherapy for 2-4 cycles before surgery.
| Study group | Role | What they receive |
|---|---|---|
| NACS | The patients with advanced gastric cancer who received neoadjuvant chemotherapy followed by surgery（NACS）. Receives: Drug: Neoadjuvant Chemotherapy | |
| SA | The patients with advanced gastric cancer who received surgery alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life index
The change of quality of life index during the 2 years after surgery.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start17 Apr 2018
- Primary completion10 Jan 2022 (estimated)
- Study completion10 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for QOL; Quality of Life;Gastric Cancer; Gastrectomy;Neoadjuvant ChemotherapyStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiangqian Su, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408859
- Sponsor's protocol ID
- QOL-201804
- Status last verified
- May 2020
- First submitted
- 26 May 2020
- Last updated
- 29 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life in Patient With Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery Alone for Locally Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT04408859
- Acronym / sponsor ID
- QOL-201804
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 10 Jan 2022 (estimated)
- Study completion
- 10 Jan 2022 (estimated)
- First posted
- 29 May 2020 (actual)
- 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 purpose of this study is to explore the influence of neoadjuvant chemotherapy in the long term quality of life with advanced gastric cancer patients.
Detailed description
Preoperative adjuvant chemotherapy combined with postoperative adjuvant therapy mode was included in the 2018 version of the National Comprehensive Cancer Network (NCCN) guideline as an optional treatment (category 2B) for prospective resectable advanced gastric cancer cases (≥cT2, any N).At home and abroad, the research on neoadjuvant chemotherapy for advanced gastric cancer mainly focuses on the safety and long-term survival, and there are few studies on the quality of life. This study, according to EORTC QLQ-C30 and QLQ-STO22 assessment scale, explores the long term effect of neoadjuvant chemotherapy on the quality of life in patients with advanced gastric cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NACS | – | Drug: Neoadjuvant ChemotherapyThe patients with advanced gastric cancer who received neoadjuvant chemotherapy followed by surgery（NACS）. |
| SA | – | –The patients with advanced gastric cancer who received surgery alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have had curative resection at Beijing Cancer Hospital for advanced gastric cancer and finish the questionnaire.
Key inclusion criteria (4 listed)
- Patients age older than 18 years (including 18 years old);
- Diagnosis of adenocarcinoma of the stomach
- The clinic stage is ≥T2 and any N stage
- Patient had curative surgical resection, including proximal, distal, or total gastrectomy
Key exclusion criteria (3 listed)
- Psychiatric or psychological abnormality precluding informed consent or ability to complete questionnaires
- Non-psychiatric disorder causing a lack of capacity to give consent or an inability to complete questionnaires (ie dementia, stroke)
- Early gastric cancer.
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 |
|---|---|---|
| Neoadjuvant ChemotherapyThe patients receive neoadjuvant chemotherapy for 2-4 cycles before surgery. | Drug | NACS |
Primary outcome
Quality of life index
Time frame: 2 years
The change of quality of life index during the 2 years after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of QOL; Quality of Life;Gastric Cancer; Gastrectomy;Neoadjuvant Chemotherapy, run by Peking University Cancer Hospital & Institute at 1 site in China.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 May 2020. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zaozao Wang (0086-10-88196851, zaozao83630@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life index (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2020.