Cancer of PancreasPhase 2NCT05566743
A Study Evaluating Maintenance Therapy After First Line Chemotherapy in Metastatic Cancer Pancreas
A Phase 2 study testing Capecitabine and follow up in people with Cancer of Pancreas, run by Menoufia University at 3 sites in Egypt.
Trial summary
A randomized phase II study evaluating maintenance therapy after first line induction chemotherapy in metastatic cancer pancreas. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer of Pancreas
- What is being tested?
- Capecitabine and follow up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesEgypt
- Study dates
- 11 Sep 2022to 11 Sep 2024
- Phase
- Phase 2
- 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 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Histologically confirmed invasive adenocarcinoma of pancreas.
- Stage 4 disease according to The American Joint Committee on Cancer (AJCC the 8th Edition) 2017.
- Measurable metastases according to RECIST 1.1.
- Patients underwent surgical resection and postoperative evaluation revealed distant metastasis.
- Patients with age ranging from 18 to 69.
- WHO performance status 0-1.
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- An adequate bone marrow reserve and adequate liver and renal function as follow: Neutrophils ≥ 1500 cell/dl, Platelets ≥ 100,000 cell/dl, Hemoglobin ≥ 9.0 g/dl, Total bilirubin < 1.5 × upper normal level (UNL), SGOT and SGPT < 3 × UNL, Creatinine < 1.5 × UNL or estimated GFR > 30 ml/min.
- Adjuvant and neoadjuvant chemotherapies will be permitted if administered more than 6 months before inclusion.
- Patients with biliary or gastroduodenal obstruction must have drainage or surgical bypass prior to starting chemotherapy.
- All patients must have signed and dated informed consent form.
Who cannot join
- Endocrine or acinar pancreatic carcinoma.
- Patients who progressed during FOLFRINOX regimen.
- Pregnancy or breast feeding.
- Patients with complicated systemic diseases such as diabetes, HTN or decompensated liver disease.
- Patients with any serious uncontrolled medical conditions that might compromise study participation: Central nervous system disorders, gastrointestinal tract disorders that interfere with oral medication.
- Patients with history of previous other carcinoma except basal cell carcinoma of the skin, insitu cervical carcinoma or non-metastatic prostate cancer.
- More than grade 1 peripheral neuropathy.
- Brain metastasis.
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites, 3 recruiting
- Recruiting
Egypt
Cairo, 12345
Nahla Atef Shabaan, Master, +2001099577494, dr.nahla.atef@gmail.com
- Recruiting
Nahla Atef Shabaan
Cairo, 12345
Nahla A Shabaan, +2001099577494, dr.nahla.atef@gmail.com
Nahla Atef Shabaan, Master
- Recruiting
Nahla Atef Shabaan
Cairo, 12345
Nahla Atef Shabaan, Master, +2001099577494, dr.nahla.atef@gmail.com
About this study
Official title: A Randomized Phase II Study Evaluating Maintenance Therapy After First Line Induction Chemotherapy in Metastatic Cancer Pancreas
A randomized phase II study evaluating maintenance therapy after first line induction chemotherapy in metastatic cancer pancreas.
Read the detailed description
In this study, we aim to evaluate the role of maintenance capecitabine by comparing 2 arms of metastatic cancer pancreas patients in the first line , the first arm will receive 4 months of induction FOLFRINOX the maintenance capecitabine and the second arm will receive 4 months of FOLFRINOX then kept under follow-up:
•Primary end point: PFS.
•Secondary end points: OS, QOL and Toxicity.
- Conditions
- Cancer of Pancreas
- Being tested
- Capecitabine, follow up
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Also called Xeloda
maintenance capecitabine after 4 months of FOLFRINOX
follow upOther
follow up after 4 months of FOLFRINOX
| Study group | Role | What they receive |
|---|---|---|
| the maintenance arm | Experimental | in this arm patients will receive 4 months of induction FOLFRINOX then maintenance capecitabine Receives: Drug: Capecitabine |
| the control arm | Other | in this arm patients will receive 4 months of FOLFRINOX then kept under follow-up Receives: Other: follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
that will be calculated from the time of randomization till disease progression or death
Measured: 6 months
Secondary outcomes (1)
OS
that will be calculated from the time of starting of the disease to death (all causes)
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 posted4 Oct 2022
- Study start11 Sep 2022
- Primary completion11 Sep 2023 (estimated)
- Study completion11 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of PancreasStudies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nahla Atef Shabaan, Menoufia University
- Investigators
- Nahla Atef Shabaan, Master, Principal investigator, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566743
- Sponsor's protocol ID
- 10001
- Status last verified
- Sep 2022
- First submitted
- 22 Sep 2022
- Last updated
- 4 Oct 2022
- 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 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study Evaluating Maintenance Therapy After First Line Induction Chemotherapy in Metastatic Cancer Pancreas
- ClinicalTrials.gov ID
- NCT05566743
- Acronym / sponsor ID
- 10001
- Conditions
- Cancer of Pancreas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 11 Sep 2022 (actual)
- Primary completion
- 11 Sep 2023 (estimated)
- Study completion
- 11 Sep 2024 (estimated)
- First posted
- 4 Oct 2022 (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.
A randomized phase II study evaluating maintenance therapy after first line induction chemotherapy in metastatic cancer pancreas.
Detailed description
In this study, we aim to evaluate the role of maintenance capecitabine by comparing 2 arms of metastatic cancer pancreas patients in the first line , the first arm will receive 4 months of induction FOLFRINOX the maintenance capecitabine and the second arm will receive 4 months of FOLFRINOX then kept under follow-up:
•Primary end point: PFS.
•Secondary end points: OS, QOL and Toxicity.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the maintenance arm | Experimental | Drug: Capecitabinein this arm patients will receive 4 months of induction FOLFRINOX then maintenance capecitabine |
| the control arm | Other | Other: follow upin this arm patients will receive 4 months of FOLFRINOX then kept under follow-up |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed invasive adenocarcinoma of pancreas.
- Stage 4 disease according to The American Joint Committee on Cancer (AJCC the 8th Edition) 2017.
- Measurable metastases according to RECIST 1.1.
- Patients underwent surgical resection and postoperative evaluation revealed distant metastasis.
- Patients with age ranging from 18 to 69.
Key exclusion criteria (8 listed)
- Endocrine or acinar pancreatic carcinoma.
- Patients who progressed during FOLFRINOX regimen.
- Pregnancy or breast feeding.
- Patients with complicated systemic diseases such as diabetes, HTN or decompensated liver disease.
- Patients with any serious uncontrolled medical conditions that might compromise study participation: Central nervous system disorders, gastrointestinal tract disorders that interfere with oral medication.
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 |
|---|---|---|
| CapecitabineAlso: Xelodamaintenance capecitabine after 4 months of FOLFRINOX | Drug | the maintenance arm |
| follow upfollow up after 4 months of FOLFRINOX | Other | the control arm |
Primary outcome
PFS
Time frame: 6 months
that will be calculated from the time of randomization till disease progression or death
1 secondary outcome
OS
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- 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.
Nahla Atef Shabaan, Master principal investigator
Menoufia University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine and follow up in people with Cancer of Pancreas, run by Menoufia University at 3 sites in Egypt.
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 10 inclusion and 8 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 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Egypt. 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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Nahla Atef Shabaan, Master (+2001099577494, dr.nahla.atef@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 6 months). 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 Oct 2022.