Primarily Resectable Pancreatic CancerIMPACT2010NCT01027221
Low Dose Radiation to Improve T-Cell Infiltration in Pancreatic Cancer
A study testing neoadjuvant photon radiation in people with Primarily Resectable Pancreatic Cancer, run by German Cancer Research Center at 2 sites in Germany.
Trial summary
Principal purpose of the study is the determination of an active local external beam radiotherapy dose leading to a maximum number of tumor infiltrating T-cells. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Primarily Resectable Pancreatic Cancer
- What is being tested?
- neoadjuvant photon radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesGermany
- Study dates
- Nov 2009to Sep 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Radiological diagnosis of resectable pancreatic carcinoma is required prior to treatment. Potentially resectable is defined as no extrapancreatic disease, no evidence (on CT) of involvement of the celiac axis or superior mesenteric artery, no evidence (on CT or MRI) of occlusion of the superior mesenteric vein or superior mesenteric-portal venous confluence.
- No evidence of metastatic disease as determined by chest CT scan, abdominal CT scan (or MRI)
- 18 years of age or older
- American Society of Anesthesiologists (ASA)- Performance status of 1 to 3
- Women of child bearing potential must practice adequate contraception and refrain from breast feeding. Female patients must have a negative pregnancy test within 7 days of treatment
- Informed consent
Who cannot join
- Locally irresectable pancreatic cancer
- distant metastases
- medically unfit for surgery
- Pregnant or lactating women
- prior chemotherapy or radiation treatment
- Other serious uncontrolled medical conditions that the investigator feels might compromise study participation
Show all 9Show fewer
- Unwillingness to participate or inability to comply with the protocol for the duration of the study
- Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery
- Participation in other interventional trials
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Clinic for General, Visceral and Transplantation Surgery
Heidelberg, 69120
German Cancer Research Center
Heidelberg, 69120
About this study
Official title: Randomised Phase I/II Trial in Order to Evaluate the Effect of Neoadjuvant Radiation on Tumor Infiltrating T-cells by Neoadjuvant Low-Dose-Radiation Therapy in Primarily Resectable Pancreatic Cancer
Principal purpose of the study is the determination of an active local external beam radiotherapy dose leading to a maximum number of tumor infiltrating T-cells.
- Conditions
- Primarily Resectable Pancreatic Cancer
- Being tested
- neoadjuvant photon radiation
- Keywords
- Low Dose Radiation, pancreatic cancer, Immunostimulation
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant photon radiationRadiation
single fraction, four dimensions (4D) planned, image guided, Radiation at a dose of 0,5 Gy in Intensity modulated radiotherapy (IMRT)-technique 2 days before resection
neoadjuvant photon radiationRadiation
single fraction, 4D-planned, image guided, 2 Gy Radiation to the tumor with a safety margin, in IMRT-technique 2 days before resection
neoadjuvant photon radiationRadiation
single fraction, 4D-planned, image guided, 5 Gy Radiation to the tumor with a safety margin, in IMRT-technique 2 days before resection
| Study group | Role | What they receive |
|---|---|---|
| 0 | No intervention | primarily resectable pancreatic cancer patients |
| 0,5 Gy | Active comparator | neoadjuvant Radiation of 0,5 Gy two days before resection Receives: Radiation: neoadjuvant photon radiation |
| 2 Gy | Active comparator | neoadjuvant Radiation of 2 Gy 2 days before resection Receives: Radiation: neoadjuvant photon radiation |
| 5 Gy | Active comparator | neoadjuvant Radiation of 5 Gy 2 days before resection Receives: Radiation: neoadjuvant photon radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Principal purpose of the study is the determination of an active local external beam radiotherapy dose leading to a maximal number of tumor infiltrating T-cells. The total T-cell activity serves as primary surrogate parameters for anti- tumoral activity
Principal purpose of the study is the determination of an active local external beam radiotherapy dose leading to a maximal number of tumor infiltrating T-cells. The total T-cell activity serves as primary surrogate parameters for anti- tumoral activity
Measured: 1 year
Secondary outcomes (6)
local control and recurrence patterns of pancreatic cancer relative to a standard as seen in historical controls
local control and recurrence patterns of pancreatic cancer relative to a standard as seen in historical controls
Measured: 5 years
surgical morbidity in patients undergoing pancreatic resection who received this protocol treatment
surgical morbidity in patients undergoing pancreatic resection who received this protocol treatment
Measured: 1 year
frequencies of tumor-reactive T-cells in blood and bone marrow
frequencies of tumor-reactive T-cells in blood and bone marrow
Measured: 2 years
expression of migration-relevant adhesion molecules on tumor endothelial cells
expression of migration-relevant adhesion molecules on tumor endothelial cells
Measured: 2 years
expression of proinflammatory cytokines and activation-dependent, immune-associated transcriptionally factors in tumors and blood
expression of proinflammatory cytokines and activation-dependent, immune-associated transcriptionally factors in tumors and blood
Measured: 2 years
quality of life according to the EORTC QoL questionnaire after 6, 12, 18 and 24 months
quality of life according to the EORTC QoL questionnaire after 6, 12, 18 and 24 months
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionSep 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primarily Resectable 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Cancer Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Heidelberg University
- Responsible party
- Sponsor
- Investigators
- Peter E. Huber, Prof. PhD MD, Principal investigator, German Cancer Research Centre and Clinic for Radiation Oncology of the University of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01027221
- Sponsor's protocol ID
- IMPACT2010
- Acronym
- IMPACT2010
- Status last verified
- Nov 2017
- First submitted
- 4 Dec 2009
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Timke C, Winnenthal HS, Klug F, Roeder FF, Bonertz A, Reissfelder C, Rochet N, Koch M, Tjaden C, Buechler MW, Debus J, Werner J, Beckhove P, Weitz J, Huber PE. Randomized controlled phase I/II study to investigate immune stimulatory effects by low dose radiotherapy in primarily operable pancreatic cancer. BMC Cancer. 2011 Apr 13;11:134. doi: 10.1186/1471-2407-11-134.
PubMed 21489291
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Phase I/II Trial in Order to Evaluate the Effect of Neoadjuvant Radiation on Tumor Infiltrating T-cells by Neoadjuvant Low-Dose-Radiation Therapy in Primarily Resectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01027221
- Acronym / sponsor ID
- IMPACT2010 / IMPACT2010
- Conditions
- Primarily Resectable Pancreatic Cancer
- Keywords
- Low Dose Radiation, pancreatic cancer, Immunostimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- German Cancer Research CenterUniversity, hospital or other
- Collaborators
- Heidelberg University
- Study start
- Nov 2009 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 7 Dec 2009 (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.
Principal purpose of the study is the determination of an active local external beam radiotherapy dose leading to a maximum number of tumor infiltrating T-cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0 | No intervention | –primarily resectable pancreatic cancer patients |
| 0,5 Gy | Active comparator | Radiation: neoadjuvant photon radiationneoadjuvant Radiation of 0,5 Gy two days before resection |
| 2 Gy | Active comparator | Radiation: neoadjuvant photon radiationneoadjuvant Radiation of 2 Gy 2 days before resection |
| 5 Gy | Active comparator | Radiation: neoadjuvant photon radiationneoadjuvant Radiation of 5 Gy 2 days before resection |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Radiological diagnosis of resectable pancreatic carcinoma is required prior to treatment. Potentially resectable is defined as no extrapancreatic disease, no evidence (on CT) of involvement of the celiac axis or superior mesenteric artery, no evidence (on CT or MRI) of occlusion of the superior mesenteric vein or superior mesenteric-portal venous confluence.
- No evidence of metastatic disease as determined by chest CT scan, abdominal CT scan (or MRI)
- 18 years of age or older
- American Society of Anesthesiologists (ASA)- Performance status of 1 to 3
- Women of child bearing potential must practice adequate contraception and refrain from breast feeding. Female patients must have a negative pregnancy test within 7 days of treatment
Key exclusion criteria (9 listed)
- Locally irresectable pancreatic cancer
- distant metastases
- medically unfit for surgery
- Pregnant or lactating women
- prior chemotherapy or radiation treatment
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 |
|---|---|---|
| neoadjuvant photon radiationsingle fraction, four dimensions (4D) planned, image guided, Radiation at a dose of 0,5 Gy in Intensity modulated radiotherapy (IMRT)-technique 2 days before resection | Radiation | 0,5 Gy |
| neoadjuvant photon radiationsingle fraction, 4D-planned, image guided, 2 Gy Radiation to the tumor with a safety margin, in IMRT-technique 2 days before resection | Radiation | 2 Gy |
| neoadjuvant photon radiationsingle fraction, 4D-planned, image guided, 5 Gy Radiation to the tumor with a safety margin, in IMRT-technique 2 days before resection | Radiation | 5 Gy |
Primary outcome
Principal purpose of the study is the determination of an active local external beam radiotherapy dose leading to a maximal number of tumor infiltrating T-cells. The total T-cell activity serves as primary surrogate parameters for anti- tumoral activity
Time frame: 1 year
Principal purpose of the study is the determination of an active local external beam radiotherapy dose leading to a maximal number of tumor infiltrating T-cells. The total T-cell activity serves as primary surrogate parameters for anti- tumoral activity
6 secondary outcomes
local control and recurrence patterns of pancreatic cancer relative to a standard as seen in historical controls
Time frame: 5 years
surgical morbidity in patients undergoing pancreatic resection who received this protocol treatment
Time frame: 1 year
frequencies of tumor-reactive T-cells in blood and bone marrow
Time frame: 2 years
expression of migration-relevant adhesion molecules on tumor endothelial cells
Time frame: 2 years
expression of proinflammatory cytokines and activation-dependent, immune-associated transcriptionally factors in tumors and blood
Time frame: 2 years
quality of life according to the EORTC QoL questionnaire after 6, 12, 18 and 24 months
Time frame: 3 years
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 10 Jun 2021.
- Derived from this study: PubMed 21489291Timke C, Winnenthal HS, Klug F, Roeder FF, Bonertz A, Reissfelder C, Rochet N, Koch M, Tjaden C, Buechler MW, Debus J, Werner J, Beckhove P, Weitz J, Huber PE. Randomized controlled phase I/II study to investigate immune stimulatory effects by low dose radiotherapy in primarily operable pancreatic cancer. BMC Cancer. 2011 Apr 13;11:134. doi: 10.1186/1471-2407-11-134.
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.
Peter E. Huber, Prof. PhD MD principal investigator
German Cancer Research Centre and Clinic for Radiation Oncology of the University of Heidelberg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neoadjuvant photon radiation in people with Primarily Resectable Pancreatic Cancer, run by German Cancer Research Center at 2 sites in Germany.
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 6 inclusion and 9 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 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
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?
Principal purpose of the study is the determination of an active local external beam radiotherapy dose leading to a maximal number of tumor infiltrating T-cells. The total T-cell activity serves as primary surrogate parameters for anti- tumoral activity (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01027221, which also lists 1 linked publication.
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 Jun 2021.