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

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ClinicalTrials.gov Identifier: NCT01795274
Recruitment Status : Withdrawn (Administrative barriers)
First Posted : February 20, 2013
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Juergen Debus, University Hospital Heidelberg

Brief 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.

Condition or disease Intervention/treatment Phase
Locally Advanced Pancreatic Cancer Radiation: Carbon Ion Radiotherapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (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
Estimated Primary Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine


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 :
  1. 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 :
  1. imaging response [ Time Frame: 2 years ]
  2. progression-free survival [ Time Frame: 2 years ]
    progression-free survival

  3. overall survival [ Time Frame: 2 years ]
    overall survival



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01795274


Locations
Germany
University Hospital of Heidelberg, Radiation Oncology
Heidelberg, Germany, 69120
Sponsors and Collaborators
University Hospital Heidelberg

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Juergen Debus, Prof. Dr. Dr. Jürgen Debus, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT01795274     History of Changes
Other Study ID Numbers: PHOENIX-01
First Posted: February 20, 2013    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018

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