Carbon-ion radiotherapy on pelvic recurrent rectal cancer

JRCT ID: jRCT1032190165

Registered date:18/12/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: recurrent rectal cancer
• Date of first enrollment: 21/09/2018
• Target sample size: 32
• Study type: Interventional
• Intervention(s): Carbon-ion 73.6Gy(RBE)/16fraction

Outcome(s)

• Primary Outcome: overall survival rate at 3 years

Secondary Outcome

time 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 maximum: Not applicable
• Gender: Both
• Include criteria: 1) 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 criteria: 1) 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

• Primary Sponsor: Yamada Shigeru
• Secondary ID(s): UMIN000032650