Rectal Cancer Clinical Trial
Official title:
A Prospective Phase II Clinical Study of Carbon Ion Re-irradiation in Unresectable Locally Recurrent Rectal Cancer
Prospective phase II clinical study aim to explore the clinical outcome of patients with unresectable locally recurrent rectal cancer (LRRC) treated with re-irradiation by carbon ion radiotherapy (CIRT)
Status | Not yet recruiting |
Enrollment | 31 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - 1) pathologically confirmed rectal adenocarcinoma (including mucinous adenocarcinoma and signet-ring cell carcinoma) and LRRC confirmed by biopsy or clinical diagnosis, - 2) received a radical operation for their primary tumor and regional lymph nodes, - 3) received chemo-radiation or radiation in pelvic before CIRT, - 4) received re-irradiation by CIRT after their pelvic radiotherapy. Exclusion Criteria: - 1) received more than once prior radiotherapy in the same treatment field, - 2) time to the last radiotherapy was <1 year, - 3) space between the lesion to organ at risk (OARs) (bladder or digestive tract) was too close (<5 mm). |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Proton and Heavy ion center | Shanghai | Pudong |
Lead Sponsor | Collaborator |
---|---|
Xin Cai |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | local control | local control rate of the lesion treated by CIRT | Local control at 3 years after CIRT | |
Secondary | overall survival | survival rate after CIRT | 3 years after CIRT or patient died, measured erery 3 months after CIRT | |
Secondary | progression free survival | progression free survival rate after CIRT | 3 years after CIRT or patient died, measured erery 3 months after CIRT |
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