Pancreatic AdenocarcinomaPhase 1NCT01834170
EUS-guided Intratumoral Gemcitabine in Locally Advanced Unresectable Pancreatic Cancer
A Phase 1 study testing Gemcitabine in people with Pancreatic Adenocarcinoma, run by University of Tehran at 1 site in Iran.
Trial summary
Pancreatic cancer is the 11th most common type of cancer but it is the fourth leading cause of cancer death. The only effective treatment for pancreatic cancer includes surgery. However, only 20% of the patients have surgically treatable disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIran
- Study dates
- Apr 2013to Dec 2014
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically verified pancreatic adenocarcinoma who have locally advanced unresectable tumor
Who cannot join
- Early stage resectable pancreatic cancer with the intact surrounding major vessels on imaging
- Pancreatic cancer with distant metastasis
- Unwilling to sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EUS-guided Intratumoral Gemcitabine Therapy in Locally Advanced Unresectable Pancreatic Cancer: A Phase 1 Study
Pancreatic cancer is the 11th most common type of cancer but it is the fourth leading cause of cancer death. The only effective treatment for pancreatic cancer includes surgery. However, only 20% of the patients have surgically treatable disease. Also, the 5-year survival for the surgically treated patients is only 15%.
About 40% of the patients present with advanced disease with distant metastasis, and the remaining 40% present with locally advanced unresectable cancer with the tumor invaded into surrounding major vessels. For those with locally advanced disease, systemic chemotherapy with or without radiotherapy provides palliation of the symptoms but cannot cure the disorder. Systemic chemotherapy is given through peripheral vessels.
The investigators hypothesized that direct injection of the chemotherapeutic drug into the tumor may help to boost the effect of systemic chemotherapy and radiotherapy in those with locally advanced pancreatic cancer.
Read the detailed description
In this study, gemcitabine will be injected directly into the tumor by means of endoscopic ultrasound (EUS) in the eligible patients.
- Conditions
- Pancreatic Adenocarcinoma
- Being tested
- Gemcitabine
- Keywords
- Pancreatic cancer, Pancreatic adenocarcinoma, Endoscopic ultrasound
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemzar
Two intratumoral injections of gemcitabine under endoscopic ultrasound (EUS)-guidance at month 0 and month 3.
The patients will receive systemic chemotherapy with or without radiotherapy at the discretion of oncologist
| Study group | Role | What they receive |
|---|---|---|
| Intratumoral gemcitabine injection | Experimental | Intratumoral injection of gemcitabine by means of endoscopic ultrasound. Receives: Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as a measure of safety and tolerability
Measured: 6 months
Secondary outcomes (1)
Proportion of participants who remain alive one year after enrollment compared to the historical matched control group
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 posted17 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tehran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehdi Mohamadnejad, University of Tehran
- Investigators
- Mehdi Mohamadnejad, M.D., Principal investigator, Digestive Disease Research Center, University of Tehran/Medical sciencesReza Malekzadeh, M.D., Study chair, Digestive Disease Research Center, University of Tehran/Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834170
- Sponsor's protocol ID
- DDRC 92-1
- Status last verified
- Dec 2014
- First submitted
- 6 Apr 2013
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUS-guided Intratumoral Gemcitabine Therapy in Locally Advanced Unresectable Pancreatic Cancer: A Phase 1 Study
- ClinicalTrials.gov ID
- NCT01834170
- Acronym / sponsor ID
- DDRC 92-1
- Conditions
- Pancreatic Adenocarcinoma
- Keywords
- Pancreatic cancer, Pancreatic adenocarcinoma, Endoscopic ultrasound
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of TehranUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 17 Apr 2013 (estimated)
- 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.
Pancreatic cancer is the 11th most common type of cancer but it is the fourth leading cause of cancer death. The only effective treatment for pancreatic cancer includes surgery. However, only 20% of the patients have surgically treatable disease. Also, the 5-year survival for the surgically treated patients is only 15%.
About 40% of the patients present with advanced disease with distant metastasis, and the remaining 40% present with locally advanced unresectable cancer with the tumor invaded into surrounding major vessels. For those with locally advanced disease, systemic chemotherapy with or without radiotherapy provides palliation of the symptoms but cannot cure the disorder. Systemic chemotherapy is given through peripheral vessels.
The investigators hypothesized that direct injection of the chemotherapeutic drug into the tumor may help to boost the effect of systemic chemotherapy and radiotherapy in those with locally advanced pancreatic cancer.
Detailed description
In this study, gemcitabine will be injected directly into the tumor by means of endoscopic ultrasound (EUS) in the eligible patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intratumoral gemcitabine injection | Experimental | Drug: GemcitabineIntratumoral injection of gemcitabine by means of endoscopic ultrasound. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with histologically verified pancreatic adenocarcinoma who have locally advanced unresectable tumor
Key exclusion criteria (3 listed)
- Early stage resectable pancreatic cancer with the intact surrounding major vessels on imaging
- Pancreatic cancer with distant metastasis
- Unwilling to sign informed consent
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 |
|---|---|---|
| GemcitabineAlso: GemzarTwo intratumoral injections of gemcitabine under endoscopic ultrasound (EUS)-guidance at month 0 and month 3. The patients will receive systemic chemotherapy with or without radiotherapy at the discretion of oncologist | Drug | Intratumoral gemcitabine injection |
Primary outcome
Number of participants with adverse events as a measure of safety and tolerability
Time frame: 6 months
1 secondary outcome
Proportion of participants who remain alive one year after enrollment compared to the historical matched control group
Time frame: 1 year
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 2 Dec 2014.
Related trials for Pancreatic Adenocarcinoma
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
Pancreatic Cancer, Pancreatic Cancer Metastatic
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
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.
Mehdi Mohamadnejad, M.D. principal investigator
Digestive Disease Research Center, University of Tehran/Medical sciences
Reza Malekzadeh, M.D. study chair
Digestive Disease Research Center, University of Tehran/Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gemcitabine in people with Pancreatic Adenocarcinoma, run by University of Tehran at 1 site in Iran.
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 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: finished, as of the sponsor's last update on 2 Dec 2014. 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 Iran. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of participants with adverse events as a measure of safety and tolerability (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 2 Dec 2014.