Early-Phase Safety of Proton Therapy Equipment

Prostate Cancer Clinical Trial

Official title:

A Study of the Early-Phase Safety of Proton Therapy Equipment for Patients Suffering From Solid Cancers, and the Equipment's Operational Effectiveness.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02315989
• Other study ID #: 101-5215C
• Status: Completed
• Phase: N/A
• First received: October 30, 2014
• Last updated: November 22, 2016
• Start date: August 2014
• Est. completion date: February 2015

Study information

• Verified date: September 2014
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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.

In this study, solid cancer subjects will be treated with Sumitomo's proton therapy system. Safety and operating functionality data will be collected during the treatment and following-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Subjects who are pathologically confirmed to be suffering from solid cancer or brain tumor

2. Subjects who are measurable or with disease that is evaluable

3. Subjects who are expected to survive for at least 90 days

4. 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

5. ECOG Performance Status (ECOG PS): 0, 1 or 2

6. Patients who can cooperate with the treatment requirements and maintain the gestures required during the irradiation process

7. Patients with well functioning main organs

8. The subject retained main organ functions.

9. The subject age is between 20-75 years old

Exclusion Criteria:

1. Subjects who once received radiotherapy on the area planned to be irradiated

2. Subjects whose irradiated area has active or persistent infectious disease

3. Pregnant or possibly pregnant subjects

4. Subjects with other serious complications

5. Subjects who are judged by the Principle Investigator (or co-principle investigator) as unsuitable or because of other reasons described above

6. The subject has the radiotherapy contraindication

7. Breast feeding

8. All the subjects have no plan to conception during the treatment and within one year after treatment

9. 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Glioma
• Head and Neck Malignant Tumor
• Hepatocellular Carcinoma
• Malignant Glioma
• Neoplasms
• Prostate Cancer

Intervention

Radiation:
• proton therapy
proton therapy

Locations

Country	Name	City	State
Taiwan	ChangGungMH	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	The Frequency of Operation of the System Error	During treatment, the frequency of operation of the system error will be recorded and analyzed to see if the system can run smoothly.	Average 100 days after treatment.	No
Secondary	Percentage of Each Target Lesion Evaluation Types.(1)Complete Response(2)Partial Response,(3)Progressive Disease,(4)Stable Disease,(5) Inevaluable	Response Evaluation Criteria In Solid Tumors:(1)complete Response(CR),Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm (2)Partial Response(PR), At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. (3)Progressive Disease(PD), At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (4)Stable Disease(SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. (5) Inevaluable (NE), Inevaluable for response: specify reasons (for example: early death, malignant disease; toxicity; tumor assessments not repeated/incomplete; other (specify).	Average 100 days after treatment.	No