NIPH Clinical Trials Search

JRCT ID: jRCT1032190165

Registered date:18/12/2019

Carbon-ion radiotherapy on pelvic recurrent rectal cancer

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedrecurrent rectal cancer
Date of first enrollment21/09/2018
Target sample size32
Countries of recruitment
Study typeInterventional
Intervention(s)Carbon-ion 73.6Gy(RBE)/16fraction


Primary Outcomeoverall survival rate at 3 years
Secondary Outcometime to local failure, follow for overall survival, progression free survival, toxicity, cost-effectiveness, quality of life

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
Include criteria1) Confirmed pelvic recurrence of rectal cancer without distant metastasis. 2) Had radiographically measurable tumor. 3) Age to obtain consent is over 20 years. 4) Performance status (ECOG) of 0-2. 5) CMP and CBC with adequate hematologic variables as defined by WBC>=1000/mm3, Plt>=25,000/mm3, T-bil<3.0g/dL, AST<200 IU/L, ALT<200 IU/L, Cre<1.5 mg/dL,within 28 days of registration. 6) Expected to survive over 3 months. 7) Written consent form of the patient.
Exclude criteria1) Tumor exceeds 15 cm in greatest dimension. 2) Subjects receiving other investigational agents they received chemotherapy within 2 weeks of CIRT. 3) they had an infection at the tumor site. 4) The tumor is infiltrating the digestive tract or bladder. 5) Prior radiation to the pelvis 6. resectable by radiographic. 7) with distant metastasis. 8) Active other cancer or within 2 years of disease free period after cancer treatment. 9) Serious complications. 10) Difficult to participate in clinical trials because of mental illness. 11) Patients who doctors judged that clinical trial participation is inappropriate.

Related Information


Public contact
Name Hirotoshi Takiyama
Address 4-9-1Anagawa Inage-ku Chiba, Chiba Chiba Japan 263-8555
Telephone +81-43-206-3306
Affiliation QST Hospital
Scientific contact
Name Shigeru Yamada
Address 4-9-1Anagawa Inage-ku Chiba, Chiba Chiba Japan 263-8555
Telephone +81-43-206-3306
Affiliation QST Hospital