CClinicalTrials.gg
WithdrawnNCT01795274PHOENIX-01Updated May 17, 2018

Phase I Study Evaluating the Treatment of Patients With Locally Advanced Pancreatic Cancer With Carbon Ion Radiotherapy: The PHOENIX-01 Trial

An interventional study of Carbon Ion Radiotherapy in Locally Advanced Pancreatic Cancer, sponsored by University Hospital Heidelberg. Withdrawn at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-17.

Sponsored by University Hospital Heidelberg · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Administrative barriers
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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, 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.

02

Conditions studied

  • Locally Advanced Pancreatic Cancer
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

Browse Pancreatic Neoplasms studies →

Lead sponsor

University Hospital Heidelberg is the lead sponsor of 175 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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.)
  • 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)

Exclusion criteria

Exclusion criteria:

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Carbon Ion Radiotherapy

    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

    Radiation: Carbon Ion Radiotherapy

Interventions

  • RadiationCarbon Ion Radiotherapy

    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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 months

Secondary outcomes

  1. imaging response

    Time frame: 2 years

  2. progression-free survival

    progression-free survival

    Time frame: 2 years

  3. overall survival

    overall survival

    Time frame: 2 years

07

Study locations

1 site
  • University Hospital of Heidelberg, Radiation Oncology
    Heidelberg, 69120, Germany
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01795274
Lead sponsor
University Hospital Heidelberg
Responsible party
Juergen Debus (Prof. Dr. Dr. Jürgen Debus, University Hospital Heidelberg) — Principal investigator
First posted
Feb 20, 2013
Primary completion
May 1, 2018 (estimated)
Last update
May 17, 2018

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion