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

Not Applicable

Withdrawn

• Conditions: Locally Advanced Pancreatic Cancer
• Interventions: Radiation: Carbon Ion Radiotherapy

• Registration Number: NCT01795274
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-18
• Study First Submitted QC: 2013-02-19
• Study First Posted: 2013-02-20
• Status Verified: 2018-05
• Primary Completion: 2018-05-01
• Last Update Submitted: 2018-05-11
• Last Update Posted: 2018-05-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Carbon Ion Radiotherapy	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

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

Secondary Outcome Measures

Name	Time	Method
imaging response	2 years
progression-free survival	2 years	progression-free survival
overall survival	2 years	overall survival

Trial Locations

Locations (1)

University Hospital of Heidelberg, Radiation Oncology; 🇩🇪 Heidelberg, Germany