Pancreatic CancerTRLAPANCT03009253
Translational Research on Locally Advanced Pancreatic Adenocarcinoma
A study testing order of treatment in people with Pancreatic Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The purpose of this study is to find the best neoadjuvant therapy for pancreatic adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- order of treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Dec 2019
- Phase
- Interventional
- 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
- have cytologic or pathological proof of pancreatic adenocarcinoma without surgery contraindication score of ECOG is between 0 and 1 evaluation of CT is unresectable
Who cannot join
- metastatic pancreatc adenocarcinoma malignant tumors history allergic to 5-FU have difficulty in swallowing joined other clinical trails cardiac and renal disease active infection
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Institute and Hospital ,China Academy of Medical Sciences
Beijing, Beijing Municipality, 10021
Xu Che, M.D., 8610-87787120, xu.che@hotmail.com
About this study
The purpose of this study is to find the best neoadjuvant therapy for pancreatic adenocarcinoma.
Read the detailed description
The trial is prepared to be registered on the clinicaltrail.gov. Quality assurance plan: Every participant is enrolled or excluded by two practiced investigators. And two investigators participated in all steps of the trail, including the record of the data, and the investigators will compare the data. If the data is consistent,the investigators would record the data; if not, the data would be checked and decided by the two investigators. All the steps and data are site monitored and audited by the workers of research and financial department of National Cancer Center/ Cancer Hospital, Chinese Academy of Medical Sciences.
Data check: The investigators compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources, including medical records and electronic case report forms.
Data dictionary that contains detailed descriptions of each variable used by the registry,including the source of the variable, coding information, and normal ranges if relevant.Standard Operating Procedures to address registry operations and analysis activities,such as participants recruitment, data collection, data management, data analysis,reporting for adverse events, and change management. All registry operations would be done according to specific steps, and by two practiced investigators.
Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect. According to the formula to differ advantages and disadvantages, the investigators need at least 80 participants to take part in the trail.
The investigators can recruit about 20 participants every year according to previous experiences, so the investigators should recruit at least for two years.
Plan for missing data: the investigators would collect as much data as possible, and the investigators exclude the participants who cannot cooperate on recruitment. And the investigators manage situations according to statistical principles where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results.
Statistical analysis plan: Kaplan-Meier method would be used to analyze the difference of survival time between the two groups, and the local control rate of the two groups would be compared by chi square test. Statistical analyses would be performed by using IBM SPSS Statistics(version 20; IBM, Chicago, USA). The level of significance is defined as P < 0.05.
- Conditions
- Pancreatic Cancer
- Being tested
- order of treatment
- Keywords
- Neoadjuvant therapy, Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
order of treatmentOther
the 2 arms have different orders of treatment,participants in arm A accept concurrent chemoradiotherapy at first and then accept evalution for surgery.In arm B,participants accept concurrent chemoradiotherapy at first and then accept evalution for surgery.
| Study group | Role | What they receive |
|---|---|---|
| Concurrent chemoradiotherapy(CCRT) Group | Experimental | Concurrent chemoradiotherapy (Total dose: 30-40 Gy; Single dose: 3-4 Gy; Frequency: 10; S-1 orally (80 mg/m2/d),2 weeks) Followed by chemotherapy: Gemcitabine(GEM), 1000 mg/m2 ,Day 1,8 ); taking S-1 orally (80 mg/m2/d, bid on Day 1-14, Q21d, 3 cycles) Receives: Other: order of treatment |
| Chemotherapy Group | Experimental | Chemotherapy (Gemcitabine(GEM), 1000 mg/m2 ,Day 1,8 ); taking S-1 orally (80 mg/m2/d, bid on Day 1-14, Q21d, 3 cycles)
Followed by Concurrent chemoradiotherapy:
(Total dose: 30-40 Gy; Single dose: 3-4 Gy; Frequency: 10; S-1 orally (80 mg/m2/d),2 weeks) Receives: Other: order of treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
translational resection rate
Measured: half a year
Secondary outcomes (2)
progression-free survival
PFS
Measured: 2 years
Local control rate
LCR
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study startJul 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
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.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chengfeng Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Chengfeng Wang, B.A., Principal investigator, Investigator CancerIHCAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009253
- Sponsor's protocol ID
- GHGI061
- Acronym
- TRLAPA
- Status last verified
- Dec 2016
- First submitted
- 22 Dec 2016
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translational Research on Locally Advanced Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT03009253
- Acronym / sponsor ID
- TRLAPA / GHGI061
- Conditions
- Pancreatic Cancer
- Keywords
- Neoadjuvant therapy, Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 4 Jan 2017 (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.
The purpose of this study is to find the best neoadjuvant therapy for pancreatic adenocarcinoma.
Detailed description
The trial is prepared to be registered on the clinicaltrail.gov. Quality assurance plan: Every participant is enrolled or excluded by two practiced investigators. And two investigators participated in all steps of the trail, including the record of the data, and the investigators will compare the data. If the data is consistent,the investigators would record the data; if not, the data would be checked and decided by the two investigators. All the steps and data are site monitored and audited by the workers of research and financial department of National Cancer Center/ Cancer Hospital, Chinese Academy of Medical Sciences.
Data check: The investigators compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources, including medical records and electronic case report forms.
Data dictionary that contains detailed descriptions of each variable used by the registry,including the source of the variable, coding information, and normal ranges if relevant.Standard Operating Procedures to address registry operations and analysis activities,such as participants recruitment, data collection, data management, data analysis,reporting for adverse events, and change management. All registry operations would be done according to specific steps, and by two practiced investigators.
Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect. According to the formula to differ advantages and disadvantages, the investigators need at least 80 participants to take part in the trail.
The investigators can recruit about 20 participants every year according to previous experiences, so the investigators should recruit at least for two years.
Plan for missing data: the investigators would collect as much data as possible, and the investigators exclude the participants who cannot cooperate on recruitment. And the investigators manage situations according to statistical principles where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results.
Statistical analysis plan: Kaplan-Meier method would be used to analyze the difference of survival time between the two groups, and the local control rate of the two groups would be compared by chi square test. Statistical analyses would be performed by using IBM SPSS Statistics(version 20; IBM, Chicago, USA). The level of significance is defined as P < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concurrent chemoradiotherapy(CCRT) Group | Experimental | Other: order of treatmentConcurrent chemoradiotherapy (Total dose: 30-40 Gy; Single dose: 3-4 Gy; Frequency: 10; S-1 orally (80 mg/m2/d),2 weeks) Followed by chemotherapy: Gemcitabine(GEM), 1000 mg/m2 ,Day 1,8 ); taking S-1 orally (80 mg/m2/d, bid on Day 1-14, Q21d, 3 cycles) |
| Chemotherapy Group | Experimental | Other: order of treatmentChemotherapy (Gemcitabine(GEM), 1000 mg/m2 ,Day 1,8 ); taking S-1 orally (80 mg/m2/d, bid on Day 1-14, Q21d, 3 cycles) Followed by Concurrent chemoradiotherapy: (Total dose: 30-40 Gy; Single dose: 3-4 Gy; Frequency: 10; S-1 orally (80 mg/m2/d),2 weeks) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- have cytologic or pathological proof of pancreatic adenocarcinoma without surgery contraindication score of ECOG is between 0 and 1 evaluation of CT is unresectable
Key exclusion criteria (1 listed)
- metastatic pancreatc adenocarcinoma malignant tumors history allergic to 5-FU have difficulty in swallowing joined other clinical trails cardiac and renal disease active infection
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 |
|---|---|---|
| order of treatmentthe 2 arms have different orders of treatment,participants in arm A accept concurrent chemoradiotherapy at first and then accept evalution for surgery.In arm B,participants accept concurrent chemoradiotherapy at first and then accept evalution for surgery. | Other | Chemotherapy Group, Concurrent chemoradiotherapy(CCRT) Group |
Primary outcome
translational resection rate
Time frame: half a year
2 secondary outcomes
progression-free survival
Time frame: 2 years
Local control rate
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
- Individual participant dataSharing planned: Undecided
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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.
Chengfeng Wang, B.A. principal investigator
Investigator CancerIHCAMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing order of treatment in people with Pancreatic Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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?
The sponsor lists 1 inclusion and 1 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 Jan 2017. 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?
Contact Xu Che, M.D (8610-87787120, xu.che@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
translational resection rate (time frame: half a year). 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 Jan 2017.