Compilation of Worldwide Past and Current Clinical Trials in Proton and Carbon Beam Therapy
Reporter: Abigail Berman Milby, MD
The Abramson Cancer Center of the University of Pennsylvania
Last Modified: May 21, 2012
Presenting Author/Institution: Huan Giap, PTCOG
- Currently there is no database of proton therapy completed and open protocols for patients or physicians. Such a service would be very helpful for both patient care needs as well as collaborative research.
- There are multiple resources for identifying completed clinical trials as a whole, including clinicaltrials.gov by the NCI as well as the OncoLink clinical trials matching service.
- A collaborative effort from PTCOG publication committee was initiated in May 2011 to collect past and current clinical trials in proton and carbon team therapy at worldwide facilities.
- The database will be updated periodically and posted at PTCOG website and made available to all clinicians to facilitate patient recruitments and planning of future clinical trials.
- This initiative was approved by the PTCOG steering committee in May 2011.
- A one-page template was designed by the PTCOG publication committee.
- A request for clinical trials was send out to all steering committee members. Data were also collected at institutional and public websites including the NCI site clinicaltrials.gov was audited.
- Received data was compiled into a one-page form, which including the following fields:
- Principal Investigator, Contact, Institution, Recruitment Status, Study Purpose, Primary Aims, Secondary Aims, Methods, and Eligibility.
- Website links and contacts were given for further detailed information. Forms were tabulated by clinical site. The information will eventually be available as a smartphone app for iPad, iPhone, and Android platform for easy access.
- There were 54 protocols from 10 centers, of which there were 3 carbon protocols and 53 proton protocols (2 protocols utilized carbon and protons).
- Four of these protocols were randomized.
- University of Florida Proton Therapy Institute contributed the largest number with 22 protocols
- Most protocols were single institution (49) and 5 were multicenter.
- There were 19 clinical protocols by combined modalities.
- Clinical protocols by status was as follows: open 43, closed 7, and not sure 4.
- By site: pediatrics (7), CNS/BO S (9), sarcoma/spine (7), head and neck (4), thoracic (8), GI (6), prostate (9), GYN (1), and recurrence (1).
- There are currently two phase III randomized trials of proton vs. photon at HIT, one for chondrosarcoma and one for sarcomas. Both of these trials are designed as a non-inferiority trial.
- There is also the CLEOPATRA trial which includes GBM patients randomized to a standard arm of proton beam therapy of 5 fractions to 60 Gy versus 6 fractions of carbon ion therapy to the macroscopic tumor of T1-contrast enhancement . There is also a randomized trial of carbon ion radiotherapy versus stereotactic radiotherapy in recurrent GBMs (over 400 patients), comparing initially as a phase I dose escalation carbon ion therapy 10 x 3 or 16 x 3 and then randomizing the winning arm against fractionated stereotactic RT to 36 Gy in 2 Gy fractions.
- There are multiple trials investigating stereotactic proton beam therapy in the following disease sites: stage I lung cancer, liver metastases, prostate cancer.
- This is a first attempt by PTCOG to develop a central database for all past and current clinical trials for particle beam therapy.
- The success of this initiative will depend on the continuing support, feedback, and contribution from all particle beam centers.
- The quality of the data will be dependent on participation and quality assurance.
- This resource will benefit the recruitment of new patients into the study and future planning of new clinical studies by particle beam practitioners.
- This is a resource for clinicians, government, insurance, patients, and advocates.
- This report is an impressive description of a much-needed proton trial database. This database will permit the following:
- Identification of patients to the appropriate proton clinical trial.
- Resource for clinicians who need to identify a worldwide expert who has treated a specific type of tumor.
- Prevention of duplication of identical clinical trials at separate institutions answering the same research question.
- Facilitation of collaborative research projects.
- This is particularly needed in proton beam therapy because many of the disease sites treated are rare and therefore multi-institutional studies are needed to make definitive conclusions about the best treatment and role of proton therapy.
- A future direction for this proton clinical trials registry could include quality assurance for proton beam planning. In addition, web-based queries could be built into the registry to assess the type of clinical trials that patients are seeking but not yet available and therefore guide the next group of proton therapy trials.
January 30, 2015
February 11, 2016