Status:
WITHDRAWN
Phase I Study Evaluating the Treatment of Patients With Locally Advanced Pancreatic Cancer With Carbon Ion Radiotherapy: The PHOENIX-01 Trial
Lead Sponsor:
University Hospital Heidelberg
Conditions:
Locally Advanced Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01795274
Last Update
May 17 2018
Active Locations (1)
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1
University Hospital of Heidelberg, Radiation Oncology
Heidelberg, Germany, 69120