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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Locally Advanced Pancreatic Cancer

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Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Acute toxicity of carbon ion radiotherapy observed within 3 months of study treatment

Outcome Description:

Acute toxicity of carbon ion radiotherapy observed within 3 months of study treatment

Outcome Time Frame:

3 months

Safety Issue:

Yes

Authority:

Germany: Ethics Commission

Study ID:

PHOENIX-01

NCT ID:

NCT01795274

Start Date:

April 2013

Completion Date:

April 2015

Related Keywords:

  • Locally Advanced Pancreatic Cancer
  • Pancreatic Neoplasms

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