Pancreatic CancerPhase 2CHIPACNCT02767752
Gemcitabine and Capecitabine With or Without T-ChOS as Adjuvant Therapy for Patients With Resected Pancreatic Cancer
A Phase 2 study testing T-ChOS, Gemcitabine and Capecitabine in people with Pancreatic Cancer, run by Herlev Hospital at 1 site in Denmark.
Trial summary
This is a single center, randomized, double-blind, placebo-controlled phase II trial that will compare the efficacy of T-ChOS in combination with gemcitabine to gemcitabine alone as adjuvant treatment for 6 months in patients with surgically resected pancreatic adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- T-ChOS, Gemcitabine and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2016to Jul 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1). Subjects with neuroendocrine (and mixed type) tumors are excluded
- Subject should be able to start treatment no later than 12 weeks post-surgery
- Male or non-pregnant, non-lactating females who are ≥18 years of age at the time of signing the informed consent form (ICF)
- ECOG/WHO Performance Status (PS) 0-1
- Females of child-bearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy [the surgical removal of both ovaries] or (2) has not been naturally postmenopausal for at least 24 consecutive months [i.e., has had menses at any time during the preceding 24 consecutive months]) must:
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- Agree to the use of two physician-approved contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study IP; and for 3months following the last dose of IP
- Has negative serum pregnancy test (β-hCG) result at screening
- Male subjects:
- Must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following IP discontinuation, even if he has undergone a successful vasectomy
- Understand and voluntarily sign an ICF prior to any study related assessments or procedures being conducted
- Be able to adhere to the study visit schedule and other protocol requirements
- Acceptable hematology parameters defined as:
- Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹/L
- Platelet count ≥ 100 x 10⁹/L
- Haemoglobin ≥ 5.6 mmol/L
- Acceptable liver function defined as:
- Serum bilirubin < 1.5 x upper limit of normal (ULN)
- ASAT/ALAT < 2.5 x ULN
- Acceptable renal function with a creatinine clearance ≥ 50 mL/min/ (e.g., using the Cockroft-Gault formula)
Who cannot join
- Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma
- Presence of or history of metastatic or locally recurrent pancreatic adenocarcinoma
- Other malignancies, except adequately treated basal carcinoma or squamous cell carcinoma of the skin or in situ cervix carcinoma or incidental prostate cancer (T1a, Gleason score ≤ 6, PSA < 0.5 ng/ml), or any other tumor with a DSF survival of ≥ 5 years
- History of serious or concurrent illness or uncontrolled medical disorder; any medical condition that might be aggravated by chemotherapy treatment or which could not be controlled; including, but not restricted to:
- Active infection requiring antibiotics within 2 weeks before the study inclusion
- Concurrent congestive heart failure NYHA class III - IV
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- Unstable angina pectoris, or myocardial infarction within 6 months and/or prior poorly controlled hypertension
- History of interstitial lung disease, slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies
- Concomitant use of immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications
- Known or suspected allergy to the investigational agents or any agents given in association with this trial
- Any psychological, familial, sociological, or geographical condition which does not permit protocol compliance and medical follow-up
- Enrollment in any other clinical protocol or investigational study with an interventional agent or assessments that may interfere with study procedures
- Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
- Any condition that confounds the ability to interpret data from the study
- Unwillingness or inability to comply with study procedures
- Current use of anticoagulation therapy such as heparins both unfractionated and low molecular weighted
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Gemcitabine (GEM) and Capecitabine (CAP) With or Without T-ChOS as Adjuvant Therapy in Patients With Surgically Resected Pancreatic Cancer.
This is a single center, randomized, double-blind, placebo-controlled phase II trial that will compare the efficacy of T-ChOS in combination with gemcitabine to gemcitabine alone as adjuvant treatment for 6 months in patients with surgically resected pancreatic adenocarcinoma.
- Conditions
- Pancreatic Cancer
- Being tested
- T-ChOS, Gemcitabine, Placebo, Capecitabine
- Keywords
- Resectable pancreatic cancer, Adjuvant
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-ChOSDietary supplement
Also called Benecta™
GemcitabineDrug
PlaceboDietary supplement
Also called Sugar pill manufactured to mimic 300 mg capsule
CapecitabineDrug
Also called Xeloda
| Study group | Role | What they receive |
|---|---|---|
| T-ChOS + Gemcitabine + Capecitabine | Experimental | T-ChOS: 600 mg given p.o. (two capsules, each 300 mg) daily in the morning 30 minutes before food.
Gemcitabine: 1000 mg/m²i.v. on day 1, day 8 and day 15 of every 28 day cycle. Capecitabine: 1660 mg/m²/day p.o. twice daily 21/28 day i. e. 24 weeks. Receives: Dietary Supplement: T-ChOS; Drug: Gemcitabine; Drug: Capecitabine |
| Placebo + Gemcitabine + Capecitabine | Placebo comparator | Placebo: 600 mg given p.o. (two capsules, each 300 mg) daily in the morning 30 minutes before food.
Gemcitabine: 1000 mg/m²i.v. on day 1, day 8 and day 15 of every 28 day cycle. Capecitabine: 1660 mg/m²/day p.o. twice daily 21/28 day i. e. 24 weeks. Receives: Drug: Gemcitabine; Dietary Supplement: Placebo; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (DFS)
Time from the date of randomization to the date of disease recurrence or death, whichever is earlier.
Measured: up to approximately 9 months
Secondary outcomes (3)
Overall Survival
Time from the date of randomization to the date of death
Measured: up to approximately 18 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Assesment by CTCAE v4.0
Measured: up to approximately 18 months
Quality of Life
Quality of Life Questionnaire C30 (QLQ-C30) Version 3.0
Measured: up to approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study startNov 2016
- Primary completionJul 2018
- Study completionJul 2018
Why it stopped: Poor accrual and change of SOC (FOLFIRINOX in adjuvant setting)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GENIS
- Responsible party
- Principal investigator, Inna Chen, MD, Herlev Hospital
- Investigators
- Inna Chen, MD, Principal investigator, Herlev & Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02767752
- Sponsor's protocol ID
- GI 1604
- Acronym
- CHIPAC
- Status last verified
- Jul 2018
- First submitted
- 6 May 2016
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Gemcitabine (GEM) and Capecitabine (CAP) With or Without T-ChOS as Adjuvant Therapy in Patients With Surgically Resected Pancreatic Cancer.
- ClinicalTrials.gov ID
- NCT02767752
- Acronym / sponsor ID
- CHIPAC / GI 1604
- Conditions
- Pancreatic Cancer
- Keywords
- Resectable pancreatic cancer, Adjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual and change of SOC (FOLFIRINOX in adjuvant setting)
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Collaborators
- GENIS
- Study start
- Nov 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 10 May 2016 (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.
This is a single center, randomized, double-blind, placebo-controlled phase II trial that will compare the efficacy of T-ChOS in combination with gemcitabine to gemcitabine alone as adjuvant treatment for 6 months in patients with surgically resected pancreatic adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T-ChOS + Gemcitabine + Capecitabine | Experimental | Dietary Supplement: T-ChOS, Drug: Gemcitabine, Drug: CapecitabineT-ChOS: 600 mg given p.o. (two capsules, each 300 mg) daily in the morning 30 minutes before food. Gemcitabine: 1000 mg/m²i.v. on day 1, day 8 and day 15 of every 28 day cycle. Capecitabine: 1660 mg/m²/day p.o. twice daily 21/28 day i. e. 24 weeks. |
| Placebo + Gemcitabine + Capecitabine | Placebo comparator | Drug: Gemcitabine, Dietary Supplement: Placebo, Drug: CapecitabinePlacebo: 600 mg given p.o. (two capsules, each 300 mg) daily in the morning 30 minutes before food. Gemcitabine: 1000 mg/m²i.v. on day 1, day 8 and day 15 of every 28 day cycle. Capecitabine: 1660 mg/m²/day p.o. twice daily 21/28 day i. e. 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Signed informed consent
- Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1). Subjects with neuroendocrine (and mixed type) tumors are excluded
- Subject should be able to start treatment no later than 12 weeks post-surgery
- Male or non-pregnant, non-lactating females who are ≥18 years of age at the time of signing the informed consent form (ICF)
- ECOG/WHO Performance Status (PS) 0-1
Key exclusion criteria (16 listed)
- Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma
- Presence of or history of metastatic or locally recurrent pancreatic adenocarcinoma
- Other malignancies, except adequately treated basal carcinoma or squamous cell carcinoma of the skin or in situ cervix carcinoma or incidental prostate cancer (T1a, Gleason score ≤ 6, PSA < 0.5 ng/ml), or any other tumor with a DSF survival of ≥ 5 years
- History of serious or concurrent illness or uncontrolled medical disorder; any medical condition that might be aggravated by chemotherapy treatment or which could not be controlled; including, but not restricted to:
- Known or suspected allergy to the investigational agents or any agents given in association with this trial
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 |
|---|---|---|
| T-ChOSAlso: Benecta™ | Dietary supplement | T-ChOS + Gemcitabine + Capecitabine |
| Gemcitabine | Drug | Placebo + Gemcitabine + Capecitabine, T-ChOS + Gemcitabine + Capecitabine |
| PlaceboAlso: Sugar pill manufactured to mimic 300 mg capsule | Dietary supplement | Placebo + Gemcitabine + Capecitabine |
| CapecitabineAlso: Xeloda | Drug | Placebo + Gemcitabine + Capecitabine, T-ChOS + Gemcitabine + Capecitabine |
Primary outcome
Disease-free survival (DFS)
Time frame: up to approximately 9 months
Time from the date of randomization to the date of disease recurrence or death, whichever is earlier.
3 secondary outcomes
Overall Survival
Time frame: up to approximately 18 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: up to approximately 18 months
Quality of Life
Time frame: up to approximately 18 months
Results and safety
The study was stopped early (reason given: Poor accrual and change of SOC (FOLFIRINOX in adjuvant setting)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
- Individual participant dataSharing planned: Yes
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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.
Inna Chen, MD principal investigator
Herlev & Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing T-ChOS, Gemcitabine and Capecitabine in people with Pancreatic Cancer, run by Herlev Hospital at 1 site in Denmark.
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 20 inclusion and 16 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: stopped early, as of the sponsor's last update on 10 Jul 2018. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: Poor accrual and change of SOC (FOLFIRINOX in adjuvant setting)). Results are not available in the source record.
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?
Disease-free survival (DFS) (time frame: up to approximately 9 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 10 Jul 2018; AzTrials last refreshed its copy on 7 Nov 2026.