Resectable Pancreatic CarcinomaPhase 2NCT01333124
Preoperative Chemoradiotherapy With Gemcitabine for Resectable Pancreatic Carcinoma
A Phase 2 study testing chemoradiotherapy with Gemcitabine and Radiation: chemoradiotherapy with Gemcitabine in people with Resectable Pancreatic Carcinoma, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
This phase II study is to evaluate the efficacy of preoperative chemoradiotherapy with gemcitabine (400mg/m2, weekly) for resectable pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Resectable Pancreatic Carcinoma
- What is being tested?
- chemoradiotherapy with Gemcitabine and Radiation: chemoradiotherapy with Gemcitabine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Sep 2011to 31 Dec 2017
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with resectable pancreatic adenocarcinoma
- Age over 18 years old and younger than 70 year old
- Performance status (ECOG scale): 0-1
- Adequate organ functions
- Hb ≥9.0 g/dl
- ANC ≥1,500/mm3
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- PLT ≥100,000/mm3
- Liver function: Total Bilirubin ≤3.0 mg/dl AST/ALT/ALP ≤3× upper limit of normal
- Creatinine ≤1.5 ULN
- Patients should sign a written informed consent before study entry.
Who cannot join
- Tumor type other than adenocarcinoma
- Unresectable for resection on preoperative evaluation
- Other primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence)
- Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive immunotherapy)
- Prior radiotherapy
- Major surgery within 4 weeks prior to study treatment
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- Serious illness or medical conditions, as follows;
- congestive heart failure (NYHA class III or IV)
- unstable angina or myocardial infarction within the past 6 months,
- significant arrhythmias requiring medication and conduction abnormality such as over 2nd degree AV block
- uncontrolled hypertension
- hepatic cirrhosis( ≥ Child class B)
- interstitial pneumonia, pulmonary adenomatosis
- psychiatric disorder that may interfere with and/or protocol compliance
- unstable diabetes mellitus
- uncontrolled ascites or pleural effusion
- active infection
- Received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drug
- Pregnant or lactating woman
- Women of child bearing potential not using a contraceptive method
- Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential
- Any patients judged by the investigator to be unfit to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Study of Preoperative Chemoradiotherapy With Gemcitabine for Resectable Pancreatic Carcinoma
This phase II study is to evaluate the efficacy of preoperative chemoradiotherapy with gemcitabine (400mg/m2, weekly) for resectable pancreatic cancer.
Read the detailed description
The primary objective of this study is to evaluate the complete (R0) resection rate for patients with and resectable pancreatic cancer treated with preoperative chemoradiotherapy and curative surgery. An experimental arm that result a complete resection rate of at least 90% would merit further study. With 90% power to reject that null hypothesis that the true complete resection rate is ≤75% with a type I error level of 5%, evaluable 53 patients are required. Considering the 20% unevaluable patients due to the immediate distant metastasis after treatment7, 8, 17 and 10% follow up loss, a total of 64 eligible patients will be enrolled.
- Conditions
- Resectable Pancreatic Carcinoma
- Being tested
- chemoradiotherapy with Gemcitabine, Radiation: chemoradiotherapy with Gemcitabine
- Keywords
- Preoperative chemoradiotherapy with Gemcitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemoradiotherapy with GemcitabineRadiation
All patients will receive gemcitabine 400 mg/m2 as an intravenous 30-min infusion on day 1, 8, 15, 22, and 29 with radiotherapy.After 4-6 week from end date of chemoradiotherapy, patients undergo preoperative evaluation including CT, PET, CA19-9, CEA. If the patient is feasible for resection on this evaluation, the surgery is performed in 1 to 2 weeks. After surgery, patients will receive gemcitabine 1000 mg/m2 as an intravenous 30-min infusion on day 1, 8, and 15 for every 28 days. Subjects will be treated for at least 1 cycle and to a maximum of four cycles of adjuvant chemotherapy unless there is documented relapse, unacceptable adverse events or withdrawal of consent.
Radiation: chemoradiotherapy with GemcitabineRadiation
Radiation: chemoradiotherapy with Gemcitabine
| Study group | Role | What they receive |
|---|---|---|
| Radiation: chemoradiotherapy with Gemcitabine | Experimental | Radiation: chemoradiotherapy with Gemcitabine All patients will receive gemcitabine 400 mg/m2 as an intravenous 30-min infusion on day 1, 8, 15, 22, and 29 with radiotherapy.After 4-6 week from end date of chemoradiotherapy, patients undergo preoperative evaluation including CT, PET, CA19-9, CEA. If the patient is feasible for resection on this evaluation, the surgery is performed in 1 to 2 weeks. After surgery, patients will receive gemcitabine 1000 mg/m2 as an intravenous 30-min infusion on day 1, 8, and 15 for every 28 days. Subjects will be treated for at least 1 cycle and to a maximum of four cycles of adjuvant chemotherapy unless there is documented relapse, unacceptable adverse events or withdrawal of consent. Receives: Radiation: chemoradiotherapy with Gemcitabine; Radiation: Radiation: chemoradiotherapy with Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete resection rate
To evaluate the impact of preoperative chemoradiotherapy with gemcitabine by analyzing complete resection rate (R0).
Measured: Within the first 30 days after surgery
Secondary outcomes (3)
Clinical outcomes
To investigate the association between radiologic, histopathologic response, complete resection rate of preoperative chemoradiotherapy with gemcitabine and clinical outcomes, such overall survival and disease-free survival.
Measured: Up to 3years from a initial follow-up
The association between biomolecular markers and clinical outcomes
To investigate the association between biomolecular markers and clinical outcomes (including tumor response and complete resection rate, etc.)
Measured: Up to 3years until study closed
The feasibility and compliance
To evaluate the feasibility and compliance (acute and late toxicity, esp. gastrointestinal tract toxicity) of preoperative chemoradiotherapy with gemcitabine for resectable pancreatic cancer.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2011 (estimated)
- Study start28 Sep 2011
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Why it stopped: Recruitment delay
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Pancreatic CarcinomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sang-Jae Park, National Cancer Center, Korea
- Investigators
- Sang-Jae Park, M.D., Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333124
- Sponsor's protocol ID
- NCCCTS-10-500
- Status last verified
- Apr 2020
- First submitted
- 1 Apr 2011
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Preoperative Chemoradiotherapy With Gemcitabine for Resectable Pancreatic Carcinoma
- ClinicalTrials.gov ID
- NCT01333124
- Acronym / sponsor ID
- NCCCTS-10-500
- Conditions
- Resectable Pancreatic Carcinoma
- Keywords
- Preoperative chemoradiotherapy with Gemcitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment delay
- Enrolment
- 23 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- 28 Sep 2011 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 11 Apr 2011 (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 phase II study is to evaluate the efficacy of preoperative chemoradiotherapy with gemcitabine (400mg/m2, weekly) for resectable pancreatic cancer.
Detailed description
The primary objective of this study is to evaluate the complete (R0) resection rate for patients with and resectable pancreatic cancer treated with preoperative chemoradiotherapy and curative surgery. An experimental arm that result a complete resection rate of at least 90% would merit further study. With 90% power to reject that null hypothesis that the true complete resection rate is ≤75% with a type I error level of 5%, evaluable 53 patients are required. Considering the 20% unevaluable patients due to the immediate distant metastasis after treatment7, 8, 17 and 10% follow up loss, a total of 64 eligible patients will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation: chemoradiotherapy with Gemcitabine | Experimental | Radiation: chemoradiotherapy with Gemcitabine, Radiation: Radiation: chemoradiotherapy with GemcitabineRadiation: chemoradiotherapy with Gemcitabine All patients will receive gemcitabine 400 mg/m2 as an intravenous 30-min infusion on day 1, 8, 15, 22, and 29 with radiotherapy.After 4-6 week from end date of chemoradiotherapy, patients undergo preoperative evaluation including CT, PET, CA19-9, CEA. If the patient is feasible for resection on this evaluation, the surgery is performed in 1 to 2 weeks. After surgery, patients will receive gemcitabine 1000 mg/m2 as an intravenous 30-min infusion on day 1, 8, and 15 for every 28 days. Subjects will be treated for at least 1 cycle and to a maximum of four cycles of adjuvant chemotherapy unless there is documented relapse, unacceptable adverse events or withdrawal of consent. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with resectable pancreatic adenocarcinoma
- Age over 18 years old and younger than 70 year old
- Performance status (ECOG scale): 0-1
- Adequate organ functions
- Patients should sign a written informed consent before study entry.
Key exclusion criteria (22 listed)
- Tumor type other than adenocarcinoma
- Unresectable for resection on preoperative evaluation
- Other primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence)
- Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive immunotherapy)
- Prior radiotherapy
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 |
|---|---|---|
| chemoradiotherapy with GemcitabineAll patients will receive gemcitabine 400 mg/m2 as an intravenous 30-min infusion on day 1, 8, 15, 22, and 29 with radiotherapy.After 4-6 week from end date of chemoradiotherapy, patients undergo preoperative evaluation including CT, PET, CA19-9, CEA. If the patient is feasible for resection on this evaluation, the surgery is performed in 1 to 2 weeks. After surgery, patients will receive gemcitabine 1000 mg/m2 as an intravenous 30-min infusion on day 1, 8, and 15 for every 28 days. Subjects will be treated for at least 1 cycle and to a maximum of four cycles of adjuvant chemotherapy unless there is documented relapse, unacceptable adverse events or withdrawal of consent. | Radiation | Radiation: chemoradiotherapy with Gemcitabine |
| Radiation: chemoradiotherapy with GemcitabineRadiation: chemoradiotherapy with Gemcitabine | Radiation | Radiation: chemoradiotherapy with Gemcitabine |
Primary outcome
Complete resection rate
Time frame: Within the first 30 days after surgery
To evaluate the impact of preoperative chemoradiotherapy with gemcitabine by analyzing complete resection rate (R0).
3 secondary outcomes
Clinical outcomes
Time frame: Up to 3years from a initial follow-up
The association between biomolecular markers and clinical outcomes
Time frame: Up to 3years until study closed
The feasibility and compliance
Time frame: Up to 1 year
Results and safety
The study was stopped early (reason given: Recruitment delay). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
- 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.
Sang-Jae Park, M.D. principal investigator
National Cancer Center, Korea
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 chemoradiotherapy with Gemcitabine and Radiation: chemoradiotherapy with Gemcitabine in people with Resectable Pancreatic Carcinoma, run by National Cancer Center, Korea at 1 site in South Korea.
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 22 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 6 Apr 2020. 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 South Korea. 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?
The study was stopped early (reason given: Recruitment delay). 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?
Complete resection rate (time frame: Within the first 30 days after surgery). 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 6 Apr 2020.