Re-irradiation Therapy of Locally Recurrent Rectal Cancer With Carbon Ion
Phase 2
Not yet recruiting
- Conditions
- Rectal CancerRecurrent
- Registration Number
- NCT05807984
- Lead Sponsor
- Xin Cai
- Brief Summary
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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 31
Inclusion Criteria
-
- pathologically confirmed rectal adenocarcinoma (including mucinous adenocarcinoma and signet-ring cell carcinoma) and LRRC confirmed by biopsy or clinical diagnosis,
-
- received a radical operation for their primary tumor and regional lymph nodes,
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- received chemo-radiation or radiation in pelvic before CIRT,
-
- received re-irradiation by CIRT after their pelvic radiotherapy.
Exclusion Criteria
-
- received more than once prior radiotherapy in the same treatment field,
-
- time to the last radiotherapy was <1 year,
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- space between the lesion to organ at risk (OARs) (bladder or digestive tract) was too close (<5 mm).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method local control Local control at 3 years after CIRT local control rate of the lesion treated by CIRT
- Secondary Outcome Measures
Name Time Method progression free survival 3 years after CIRT or patient died, measured erery 3 months after CIRT progression free survival rate after CIRT
overall survival 3 years after CIRT or patient died, measured erery 3 months after CIRT survival rate after CIRT
Trial Locations
- Locations (1)
Shanghai Proton and Heavy ion center
🇨🇳Shanghai, Pudong, China