Early-Phase Safety of Proton Therapy Equipment

NCT02315989 | Completed Results DMC

• 1 other identifier: 101-5215C
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to collect the safety data of Sumitomo Heavy Industries' proton therapy equipment for the treatment of solid cancer patients in Linkou Chang Gung Memorial Hospital, including the patients' early-stage adverse reactions and the efficacy on tumors, as well as to assess the operating functionality of the proton therapy system.

Conditions

Malignant Glioma; Hepatocellular Carcinoma; Head and Neck Malignant Tumor; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Rate and Severity of Adverse Reactions

  After enrollment, each patient has to receive physical examination, laboratory tests, and image studies as baseline. During the course of radiotherapy, patients will have weekly evaluations in physicals and laboratory tests. Image studies are optional during treatment. In the follow-up periods, monthly exams, including regular physicals, markers in serum and urine and image studies to evaluation treatment responses, will be scheduled till 90 days after the end of treatment.

  Average 90 days after treatment.

Secondary Outcomes (2)

• Percentage of System Errors

  Average 100 days after treatment.

• Percentage of Each Target Lesion Evaluation Types.(1)Complete Response(2)Partial Response,(3)Progressive Disease,(4)Stable Disease,(5) Inevaluable

  Average 100 days after treatment.

Study Arms (1)

safety

OTHER

proton therapy

Radiation: proton therapy

Interventions

proton therapy RADIATION

proton therapy

safety

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who are pathologically confirmed to be suffering from solid cancer or brain tumor
• Subjects who are measurable or with disease that is evaluable
• Subjects who are expected to survive for at least 90 days
• Subjects who did not receive any treatment that may affect this treatment (such as PEI, TAE) 4 weeks before they are chosen to receive this treatment
• ECOG Performance Status (ECOG PS): 0, 1 or 2
• Patients who can cooperate with the treatment requirements and maintain the gestures required during the irradiation process
• Patients with well functioning main organs
• The subject retained main organ functions.
• The subject age is between 20-75 years old

You may not qualify if:

• Subjects who once received radiotherapy on the area planned to be irradiated
• Subjects whose irradiated area has active or persistent infectious disease
• Pregnant or possibly pregnant subjects
• Subjects with other serious complications
• Subjects who are judged by the Principle Investigator (or co-principle investigator) as unsuitable or because of other reasons described above
• The subject has the radiotherapy contraindication
• Breast feeding
• All the subjects have no plan to conception during the treatment and within one year after treatment
• Subject who has any electronic devices in the body which could be affected by radiotherapy and has chance to cause accident. For example: pacemaker, artificial heart, brain and spinal cord stimulation, semi-implantable and implantable electrical stimulation、artificial inner ear ...etc

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

ChangGungMH

Taoyuan District, Taiwan, Taiwan

Location

MeSH Terms

Conditions

Glioma; Carcinoma, Hepatocellular; Prostatic Neoplasms

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Adenocarcinoma; Carcinoma; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Hong, Ji-Hong M.D.
• Organization: Linkou Chang Gung Memorial Hospital

jihong@cgmh.org.tw

03-3281200

Study Officials

• Ji-Hong Hong, Ph.D.

  Vice-President

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2014
• First Posted: December 12, 2014
• Study Start: August 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: January 13, 2017
• Results First Posted: December 31, 2015

Record last verified: 2014-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)