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Clinical Study of Cancer Therapy
Information for people who would like to participate in the clinical studies of proton cancer therapy

Proton cancer therapy is a promising treatment equivalent to surgery, and has attracted attention as a new approach to cancer therapy which can maintain patient’s QOL (quality of life) post-treatment because of causing fewer side-effects, preserving bodily function, etc. We at WERC are conducting clinical studies to establish such clinical utility of proton cancer therapy. The preconditions for participating in the clinical studies are described below. If you conform with these preconditions and seek cancer therapy by proton beam, please send us a letter of introduction after consultation with your doctor.


Proton cancer therapy for FY2007 is scheduled to start in early July.
Applications are accepted as needed.

General conditions
  1. The patient is over age 20 and under age 80 in principle.
  2. The patient is informed about his/her condition of disease, and agrees to participate in the clinical studies of proton cancer therapy.
  3. The patient does not suffer from other serious coexisting disease, and the general medical condition is kept stable.
  4. The patient can hold the irradiation position for about 30 minutes.
  5. The patient does not have a history of previous irradiation to the treated area.
  6. There is no active or intractable infection in the treated area.

The four types of cancer: prostate cancer, hepatocellular cancer, non-small-cell lung cancer and paranasal sinus malignancy, are approved as protocols for the clinical studies of proton cancer therapy at this time. The four types of cancer: prostate cancer, hepatocellular cancer, non-small-cell lung cancer and paranasal sinus malignancy, are approved as protocols for the clinical studies of proton cancer therapy at this time.

Prostate cancer
  1. Prostate cancer confined to the prostate gland.
  2. Pretreatment PSA levels: 20.0ng/ml or less
  3. Grison score: 7 or less
  • Proton irradiation process: Total dose 67.5GyE / 27 times / 7 weeks (2.5GyE per irradiation, 4 times / week)

Hepatocellular cancer
  1. Primary hepatocellular cancer with greatest dimension 6cm or less.
  2. There is no lymph node metastasis, distant metastasis, nor tumor embolus in the portal vein.
  3. The digestive tract (stomach, duodenum, small intestine, large intestine) is kept more than 2cm from the edge of the lesion.
  4. It is not liver failure (Child-Pugh, C), and there are no RC-positive esophageal and gastric varices.
  • Proton irradiation process: Total dose 72.0GyE / 16 times / 4 weeks (4.5GyE per irradiation, 4 times / week)

Non-small-cell lung cancer
  1. Primary non-small-cell lung cancer with the greatest dimension 5cm or less which is pathologically diagnosed.
  2. There is no lymph node metastasis, nor distant metastasis.
  3. The lesion to be irradiated is clearly visible through X-ray illumination.
  4. The breathing function is kept at more than 60Torr of arterial oxygen tension. Proton irradiation process: Total dose 66.0GyE / 10 times / 2.5 weeks (6.6GyE per irradiation, 4 times / week)
  • Proton irradiation process: Total dose 66.0GyE / 10 times / 2.5 weeks (6.6GyE per irradiation, 4 times / week)

Paranasal sinus cancer
  1. Pathologically proved malignancy which has occurred primarily in nasal cavity or paranasal.
  2. There is no distant metastasis.
  3. In the case that the patient has received chemotherapy, the last anticancer drug administration must be done at least one month prior to the beginning of proton irradiation and no aftereffects are observed now.
  • Proton irradiation process: Total dose 65.0~75.0GyE / 26~30 times / 6.5~7.5 weeks (2.5GyE per irradiation, 4 times / week)


Process before beginning proton irradiation
  • After due consultation with your doctor including other medical treatments, send a letter of introduction from your doctor to WERC. The letter of introduction will be accepted as an application for participating in the clinical studies of proton cancer therapy.
  • Depending on the contents of introduction letter, the doctor in attendance at WERC will directly contact your doctor to confirm the necessary examination data.
  • Each applicant will be rigorously examined for the adequacy as the subject of the clinical studies of proton cancer therapy by the judging committee which includes outside specialists. The result will be immediately informed to you.
  • In case you are judged to be an adequate subject for the clinical studies, we will set up the date for you to visit WERC.
  • We will again give you further explanation on the clinical studies of proton cancer therapy in detail at WERC. If you agree to participate in the clinical studies with the understanding of our explanation, you will be accepted as a subject of the studies. We will then make a preparation of fixation devices for your proton irradiation, CT scanning for your therapy planning, etc.
  • There is no inpatient facility at WERC. You will be required to visit WERC each time for the duration of proton irradiation. If you wish to be hospitalized, we will recommend Municipal Tsuruga Hospital.


Possible term for implementing proton irradiation
Many other researches besides clinical studies of proton cancer therapy have been carried out at WERC, and the term to implement proton irradiation by exclusively using an accelerator for the clinical studies is limited.
The amount of time for using an accelerator in a day is also limited. Therefore you may not be selected as the subject of clinical studies of proton cancer therapy by the judging committee even if you conform with all conditions.
The Wakasa Wan Energy Research Center