Gastric Cancer, Outcomes, Pakistan, Adjuvant Chemotherapy, Perioperative ChemotherapyNCT04989764
COMPARATIVE EFFECTS OF PERIOPERATIVE AND ADJUVANT CHEMOTHERAPY ON OUTCOMES OF OPERABLE GASTRIC CANCER: EXPERIENCE FROM A CANCER CARE CENTER
An observational study of Gastric Cancer, Outcomes, Pakistan, Adjuvant Chemotherapy, Perioperative Chemotherapy, run by Shaukat Khanum Memorial Cancer Hospital & Research Centre.
Trial summary
Patients with gastric adenocarcinoma Comparison: perioperative chemotherapy vs. adjuvant therapy. Sample size differences between the two groups. Kaplan meier survival analysis, overall survival and disease free survival Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Cancer, Outcomes, Pakistan, Adjuvant Chemotherapy, Perioperative Chemotherapy
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Feb 2021
- 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 Any age
- Child, Adult, Older adult
Study population: cancer patients who had histologically proven gastric adenocarcinoma diagnosed at Shaukat Khanum Memorial Cancer Hospital and Research Centre (SKMCH \& RC), between January 2015 and December 2019
Who may be able to join
- We included histologically proven gastric adenocarcinoma patient with operable disease and the patients who completed their prescribed perioperative or adjuvant chemotherapy cycles
Who cannot join
- Patients were excluded if they had Tis or T1, N0 disease, inoperable disease, metastatic. In addition, all those who did not undergo adequate lymphadenectomy (< D2) or had R1 margins following surgery were excluded
About this study
- Patients with gastric adenocarcinoma
- Comparison: perioperative chemotherapy vs. adjuvant therapy.
- Sample size differences between the two groups.
- Kaplan meier survival analysis, overall survival and disease free survival
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| perioperative chemotherapy vs. adjuvant therapy in gastric ca patients | Not described | |
| perioperative chemotherapy group vs. adjuvant chemotherapy group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall survival
The overall survival (OS) was defined as the length of the time from date of diagnosis till last follow-up or death
Measured: from January 2015 till December 2019
The disease-free survival
The disease free survival (DFS) as the length of the time from date of last treatment which is either perioperative or adjuvant chemotherapy to tumor relapse or death.
Measured: from January 2015 till December 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study startJan 2015
- Primary completionDec 2019
- Study completionFeb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer, Outcomes, Pakistan, Adjuvant Chemotherapy, Perioperative ChemotherapyStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989764
- Sponsor's protocol ID
- EX-05-03-20-40
- Status last verified
- Jul 2021
- First submitted
- 27 Jul 2021
- Last updated
- 4 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARATIVE EFFECTS OF PERIOPERATIVE AND ADJUVANT CHEMOTHERAPY ON OUTCOMES OF OPERABLE GASTRIC CANCER: EXPERIENCE FROM A CANCER CARE CENTER
- ClinicalTrials.gov ID
- NCT04989764
- Acronym / sponsor ID
- EX-05-03-20-40
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research CentreUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 4 Aug 2021 (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.
- Patients with gastric adenocarcinoma
- Comparison: perioperative chemotherapy vs. adjuvant therapy.
- Sample size differences between the two groups.
- Kaplan meier survival analysis, overall survival and disease free survival
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| perioperative chemotherapy vs. adjuvant therapy in gastric ca patients | – | – |
| perioperative chemotherapy group vs. adjuvant chemotherapy group | – | – |
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- cancer patients who had histologically proven gastric adenocarcinoma diagnosed at Shaukat Khanum Memorial Cancer Hospital and Research Centre (SKMCH \& RC), between January 2015 and December 2019
Key inclusion criteria (1 listed)
- We included histologically proven gastric adenocarcinoma patient with operable disease and the patients who completed their prescribed perioperative or adjuvant chemotherapy cycles
Key exclusion criteria (1 listed)
- Patients were excluded if they had Tis or T1, N0 disease, inoperable disease, metastatic. In addition, all those who did not undergo adequate lymphadenectomy (< D2) or had R1 margins following surgery were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The overall survival
Time frame: from January 2015 till December 2019
The overall survival (OS) was defined as the length of the time from date of diagnosis till last follow-up or death
The disease-free survival
Time frame: from January 2015 till December 2019
The disease free survival (DFS) as the length of the time from date of last treatment which is either perioperative or adjuvant chemotherapy to tumor relapse or death.
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 4 Aug 2021.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, Outcomes, Pakistan, Adjuvant Chemotherapy, Perioperative Chemotherapy, run by Shaukat Khanum Memorial Cancer Hospital & Research Centre.
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 1 inclusion and 1 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 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The overall survival (time frame: from January 2015 till December 2019). The study lists 2 primary outcomes in all. 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 4 Aug 2021.