Pancreas CancerNCT06208436
The Survival Outcome of Adjuvant Chemotherapy for Stage I Pancreatic Cancer
An observational study of Pancreas Cancer and Chemotherapy, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This study aimed to evaluate the impact of adjuvant chemotherapy on survival in patients with Stage I pancreatic cancer stratified by pathologic risk factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer, Chemotherapy
- What is being tested?
- Adjuvant chemotherapy
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 7 Oct 2023to 28 Feb 2024
- 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: Stage I PDAC patients who underwent radical surgery.
Inclusion Criteria: Patients who underwent surgical resection and were pathologically diagnosed as PDAC between 2010 and 2021.
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Exclusion Criteria: Patients with pN1-N2, patients with pT3-T4, patients with distant metastasis, patients who received neoadjuvant therapy, patients with R1 resection, and patients who died due to perioperative mortality within 30 days.
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Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jihui
Tianjin, Tianjin Municipality, 300202
Jihui Hao, Dr, +8618622221120, haojihui@tjmuch.com
About this study
Official title: The Survival Outcome of Adjuvant Chemotherapy for Stage I Pancreatic Cancer Stratified by Pathologic Risk Factors
This study aimed to evaluate the impact of adjuvant chemotherapy on survival in patients with Stage I pancreatic cancer stratified by pathologic risk factors.
- Conditions
- Pancreas Cancer, Chemotherapy
- Being tested
- Adjuvant chemotherapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant chemotherapyOther
Patients received adjuvant chemotherapy (5-FU-based or gemcitabine-based regimens) or underwent surgery alone
| Study group | Role | What they receive |
|---|---|---|
| TMUCIH-PDAC | Between 2010 and 2021, the data of patients who underwent surgical resection and were pathologically diagnosed as PDAC from Tianjin Medical University Cancer Institute and Hospital (TMUCIH) were collected retrospectively. Receives: Other: Adjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival
The period between surgical resection to the date of recurrence.
Measured: January 2010 to February 2023
Secondary outcomes (1)
Overall survival
The period between surgical resection to the date of death.
Measured: January 2010 to February 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start7 Oct 2023
- Primary completion15 Feb 2024 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jihui Hao, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208436
- Sponsor's protocol ID
- Adchmopan01
- Status last verified
- Jan 2024
- First submitted
- 25 Dec 2023
- Last updated
- 17 Jan 2024
- 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 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Survival Outcome of Adjuvant Chemotherapy for Stage I Pancreatic Cancer Stratified by Pathologic Risk Factors
- ClinicalTrials.gov ID
- NCT06208436
- Acronym / sponsor ID
- Adchmopan01
- Conditions
- Pancreas Cancer, Chemotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 7 Oct 2023 (actual)
- Primary completion
- 15 Feb 2024 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 17 Jan 2024 (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.
This study aimed to evaluate the impact of adjuvant chemotherapy on survival in patients with Stage I pancreatic cancer stratified by pathologic risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMUCIH-PDAC | – | Other: Adjuvant chemotherapyBetween 2010 and 2021, the data of patients who underwent surgical resection and were pathologically diagnosed as PDAC from Tianjin Medical University Cancer Institute and Hospital (TMUCIH) were collected retrospectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stage I PDAC patients who underwent radical surgery.
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 |
|---|---|---|
| Adjuvant chemotherapyPatients received adjuvant chemotherapy (5-FU-based or gemcitabine-based regimens) or underwent surgery alone | Other | TMUCIH-PDAC |
Primary outcome
Recurrence-free survival
Time frame: January 2010 to February 2023
The period between surgical resection to the date of recurrence.
1 secondary outcome
Overall survival
Time frame: January 2010 to February 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Individual participant dataSharing planned: No
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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.
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 Pancreas Cancer and Chemotherapy, run by Tianjin Medical University Cancer Institute and Hospital 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?
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 17 Jan 2024. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival (time frame: January 2010 to February 2023). 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 17 Jan 2024.