NCT01795274: PHOENIX-01

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

Withdrawn NA Last updated 17 May 2018

What this trial tests

NA trial testing Carbon Ion Radiotherapy in Locally Advanced Pancreatic Cancer. Withdrawn.

Quick facts

Lead sponsor	University Hospital Heidelberg
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Primary completion	1 May 2018
Sites	1 location across Germany

Drugs / interventions tested

• Carbon Ion Radiotherapy

Conditions studied

• Locally Advanced Pancreatic Cancer — all drugs for Locally Advanced Pancreatic Cancer →

Sponsor

University Hospital Heidelberg

Who can join

18 and older, any sex, with Locally Advanced Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Bringing the heavy: carbon ion therapy in the radiobiological and clinical context.
   Schlaff CD, Krauze A, Belard A, O'Connell JJ, et al · · 2014 · cited 95× · PMID 24679134 · DOI 10.1186/1748-717x-9-88
2. Phase I study evaluating the treatment of patients with locally advanced pancreatic cancer with carbon ion radiotherapy: the PHOENIX-01 trial.
   Combs SE, Habermehl D, Kieser M, Dreher C, et al · · 2013 · cited 19× · PMID 24034562 · DOI 10.1186/1471-2407-13-419
3. Immune Stromal Components Impede Biological Effectiveness of Carbon Ion Therapy in a Preclinical Model of Pancreatic Ductal Adenocarcinoma.
   Swancutt KL, Elghonaimy EA, Nicholson JH, Pop LM, et al · · 2026 · PMID 41084839 · DOI 10.1158/1535-7163.mct-25-0501