Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by Stephanie Combs, University Hospital Heidelberg.
Recruitment status was:  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Stephanie Combs, University Hospital Heidelberg
ClinicalTrials.gov Identifier:
NCT01795274
First received: February 18, 2013
Last updated: February 19, 2013
Last verified: February 2013
  Purpose
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.

Condition Intervention Phase
Locally Advanced Pancreatic Cancer
Radiation: Carbon Ion Radiotherapy
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study Evaluating the Treatment of Patients With Locally Advanced Pancreatic Cancer With Carbon Ion Radiotherapy: The PHOENIX-01 Trial

Resource links provided by NLM:


Further study details as provided by Stephanie Combs, University Hospital Heidelberg:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • imaging response [ Time Frame: 2 years ]
  • progression-free survival [ Time Frame: 2 years ]
    progression-free survival

  • overall survival [ Time Frame: 2 years ]
    overall survival


Estimated Enrollment: 33
Study Start Date: April 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01795274

Locations
Germany
University Hospital of Heidelberg, Radiation Oncology Not yet recruiting
Heidelberg, Germany, 69120
Contact: Stephanie E Combs, Prof. Dr.    +49-6221-56 ext 8202    stephanie.combs@med.uni-heidelberg.de   
Contact: Daniel Habermehl, MD    +49-6221-56 ext 8202    daniel.habermehl@med.uni-heidelberg.de   
Sponsors and Collaborators
University Hospital Heidelberg
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stephanie Combs, Prof. Dr. Stephanie E. Combs, Leitende Oberärztin, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT01795274     History of Changes
Other Study ID Numbers: PHOENIX-01
Study First Received: February 18, 2013
Last Updated: February 19, 2013

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 25, 2017