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

Locally Advanced Pancreatic Cancer Clinical Trial

— PHOENIX-01  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01795274
• Other study ID #: PHOENIX-01
• Status: Withdrawn
• Phase: N/A

Study information

• Verified date: May 2018
• Source: University Hospital Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Locally Advanced Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Germany	University Hospital of Heidelberg, Radiation Oncology	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	imaging response		2 years
Secondary	progression-free survival	progression-free survival	2 years
Secondary	overall survival	overall survival	2 years