Locally Advanced Pancreatic CancerPHOENIX-01NCT01795274
Phase I Study Evaluating the Treatment of Patients With Locally Advanced Pancreatic Cancer With Carbon Ion Radiotherapy: The PHOENIX-01 Trial
A study testing Carbon Ion Radiotherapy in people with Locally Advanced Pancreatic Cancer, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
The physical and biological properties of the carbon ion beam promise to improve the therapeutic ratio in patients with pancreatic cancer: Due to the inverted dose profile dose deposition in the entry channel of the beam leads to sparing of normal tissue; the Bragg peak can be directed into the defined target volume… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Pancreatic Cancer
- What is being tested?
- Carbon Ion Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Start not givento 1 May 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients meeting all of the following criteria will be considered for admission to the trial:
- histologically confirmed locally advanced pancreatic cancer or imaging defined pancreatic cancer combined with elevated CA-19-9
- macroscopic tumor after biopsy
- age ≥ 18 years of age
- Karnofsky Performance Score >=60
- For women with childbearing potential, (and men) adequate contraception (sexual abstinence, estrogen- or gestagen containing contraceptive medication etc.)
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- Female participants: No pregnancy present (pregnancy test required)
- Ability of subject to understand character and individual consequences of the clinical trial
- Written informed consent (must be available before enrolment in the trial)
Who cannot join
- Patients presenting with any of the following criteria will not be included in the trial:
- distant metastases
- refusal of the patients to take part in the study
- previous radiotherapy of the abdomen
- Patients who have not yet recovered from acute toxicities of prior therapies
- Known carcinoma < 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy
- Pregnant or lactating women
- Participation in another clinical study or observation period of competing trials, respectively
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital of Heidelberg, Radiation Oncology
Heidelberg, 69120
About this study
The physical and biological properties of the carbon ion beam promise to improve the therapeutic ratio in patients with pancreatic cancer: Due to the inverted dose profile dose deposition in the entry channel of the beam leads to sparing of normal tissue; the Bragg peak can be directed into the defined target volume, and the sharp dose fall-off thereafter again spares normal tissue behind the target volume. The higher RBE of carbon ions, which has been shown also for pancreatic cancer cell lines in the preclinical setting, is likely to contribute to an increase in local control, and perhaps in OS. Early data from Japanese centers have shown convincing results. The PHOENIX-01 trial is the first trial to evaluate actively delivered carbon ion beams in patients with locally advanced pancreatic cancer within a dose-escalation strategy.
- Conditions
- Locally Advanced Pancreatic Cancer
- Being tested
- Carbon Ion Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon Ion RadiotherapyRadiation
Step 1 14 x 3 Gy E 42 Gy E Step 2: 15 x 3 Gy E 45 Gy E Step 3: 16 x 3 Gy E 49 Gy E Step 4: 17 x 3 Gy E 51 Gy E Step 5: 18 x 3 Gy E 54 Gy E
| Study group | Role | What they receive |
|---|---|---|
| Carbon Ion Radiotherapy | Experimental | Step 1 14 x 3 Gy E 42 Gy E Step 2: 15 x 3 Gy E 45 Gy E Step 3: 16 x 3 Gy E 49 Gy E Step 4: 17 x 3 Gy E 51 Gy E Step 5: 18 x 3 Gy E 54 Gy E Receives: Radiation: Carbon Ion Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute toxicity of carbon ion radiotherapy observed within 3 months of study treatment
Acute toxicity of carbon ion radiotherapy observed within 3 months of study treatment
Measured: 3 months
Secondary outcomes (3)
imaging response
Measured: 2 years
progression-free survival
progression-free survival
Measured: 2 years
overall survival
overall survival
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 posted20 Feb 2013 (estimated)
- Primary completion1 May 2018 (estimated)
Why it stopped: Administrative barriers
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 Locally Advanced Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juergen Debus, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795274
- Sponsor's protocol ID
- PHOENIX-01
- Acronym
- PHOENIX-01
- Status last verified
- May 2018
- First submitted
- 18 Feb 2013
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Combs SE, Habermehl D, Kieser M, Dreher C, Werner J, Haselmann R, Jakel O, Jager D, Buchler MW, Debus J. Phase I study evaluating the treatment of patients with locally advanced pancreatic cancer with carbon ion radiotherapy: the PHOENIX-01 trial. BMC Cancer. 2013 Sep 14;13:419. doi: 10.1186/1471-2407-13-419.
PubMed 24034562
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study Evaluating the Treatment of Patients With Locally Advanced Pancreatic Cancer With Carbon Ion Radiotherapy: The PHOENIX-01 Trial
- ClinicalTrials.gov ID
- NCT01795274
- Acronym / sponsor ID
- PHOENIX-01 / PHOENIX-01
- Conditions
- Locally Advanced Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Administrative barriers
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Primary completion
- 1 May 2018 (estimated)
- First posted
- 20 Feb 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.
The physical and biological properties of the carbon ion beam promise to improve the therapeutic ratio in patients with pancreatic cancer: Due to the inverted dose profile dose deposition in the entry channel of the beam leads to sparing of normal tissue; the Bragg peak can be directed into the defined target volume, and the sharp dose fall-off thereafter again spares normal tissue behind the target volume. The higher RBE of carbon ions, which has been shown also for pancreatic cancer cell lines in the preclinical setting, is likely to contribute to an increase in local control, and perhaps in OS. Early data from Japanese centers have shown convincing results. The PHOENIX-01 trial is the first trial to evaluate actively delivered carbon ion beams in patients with locally advanced pancreatic cancer within a dose-escalation strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carbon Ion Radiotherapy | Experimental | Radiation: Carbon Ion RadiotherapyStep 1 14 x 3 Gy E 42 Gy E Step 2: 15 x 3 Gy E 45 Gy E Step 3: 16 x 3 Gy E 49 Gy E Step 4: 17 x 3 Gy E 51 Gy E Step 5: 18 x 3 Gy E 54 Gy E |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients meeting all of the following criteria will be considered for admission to the trial:
- histologically confirmed locally advanced pancreatic cancer or imaging defined pancreatic cancer combined with elevated CA-19-9
- macroscopic tumor after biopsy
- age ≥ 18 years of age
- Karnofsky Performance Score >=60
Key exclusion criteria (8 listed)
- distant metastases
- refusal of the patients to take part in the study
- previous radiotherapy of the abdomen
- Patients who have not yet recovered from acute toxicities of prior therapies
- Known carcinoma < 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy
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 |
|---|---|---|
| Carbon Ion RadiotherapyStep 1 14 x 3 Gy E 42 Gy E Step 2: 15 x 3 Gy E 45 Gy E Step 3: 16 x 3 Gy E 49 Gy E Step 4: 17 x 3 Gy E 51 Gy E Step 5: 18 x 3 Gy E 54 Gy E | Radiation | Carbon Ion Radiotherapy |
Primary outcome
Acute toxicity of carbon ion radiotherapy observed within 3 months of study treatment
Time frame: 3 months
Acute toxicity of carbon ion radiotherapy observed within 3 months of study treatment
3 secondary outcomes
imaging response
Time frame: 2 years
progression-free survival
Time frame: 2 years
overall survival
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
- Derived from this study: PubMed 24034562Combs SE, Habermehl D, Kieser M, Dreher C, Werner J, Haselmann R, Jakel O, Jager D, Buchler MW, Debus J. Phase I study evaluating the treatment of patients with locally advanced pancreatic cancer with carbon ion radiotherapy: the PHOENIX-01 trial. BMC Cancer. 2013 Sep 14;13:419. doi: 10.1186/1471-2407-13-419.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbon Ion Radiotherapy in people with Locally Advanced Pancreatic Cancer, run by University Hospital Heidelberg at 1 site 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 9 inclusion and 8 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: withdrawn, as of the sponsor's last update on 17 May 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Acute toxicity of carbon ion radiotherapy observed within 3 months of study treatment (time frame: 3 months). 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 NCT01795274, 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 17 May 2018.