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

NCT01795274 | Withdrawn DMC

• 1 other identifier: PHOENIX-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• imaging response

  2 years

• progression-free survival

  2 years

• overall survival

  2 years

Study Arms (1)

Carbon Ion Radiotherapy

EXPERIMENTAL

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

Interventions

Carbon Ion Radiotherapy RADIATION

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

Carbon Ion Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

University Hospital of Heidelberg, Radiation Oncology

Heidelberg, 69120, Germany

Location

Related Publications (1)

• Combs SE, Habermehl D, Kieser M, Dreher C, Werner J, Haselmann R, Jakel O, Jager D, Buchler MW, Debus J. Phase I study evaluating the treatment of patients with locally advanced pancreatic cancer with carbon ion radiotherapy: the PHOENIX-01 trial. BMC Cancer. 2013 Sep 14;13:419. doi: 10.1186/1471-2407-13-419.

  PMID: 24034562 DERIVED

MeSH Terms

Interventions

Heavy Ion Radiotherapy

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Dr. Jürgen Debus

Study Record Dates

• First Submitted: February 18, 2013
• First Posted: February 20, 2013
• Primary Completion: May 1, 2018
• Last Updated: May 17, 2018

Record last verified: 2018-05

Locations

DE (1)