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

Study Overview

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

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.

N/A

Locally Advanced Pancreatic Cancer

RADIATION: Carbon Ion Radiotherapy

PHOENIX-01

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2013-02-18	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2018-05-11
First Submitted that Met QC Criteria 2013-02-19	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2018-05-17
First Posted (ACTUAL) 2013-02-20	Results First Posted N/A	Last Verified 2018-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
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 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

Participant Group/Arm

Intervention/Treatment

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

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

Primary Outcome Measures	Measure Description	Time Frame
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	3 months

Secondary Outcome Measures	Measure Description	Time Frame
imaging response		2 years
progression-free survival	progression-free survival	2 years
overall survival	overall survival	2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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)

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

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Resources

PatientS

Caregivers

Clinical Trial Record