Carbon-ion radiotherapy on pelvic recurrent rectal cancer

Phase 2

• Conditions: recurrent rectal cancer; rectal cancer

• Registration Number: JPRN-jRCT1032190165
• Lead Sponsor: Yamada Shigeru

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified