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Clinical Trials/NCT05807984
NCT05807984
Not yet recruiting
Phase 2

A Prospective Phase II Clinical Study of Carbon Ion Re-irradiation in Unresectable Locally Recurrent Rectal Cancer

Xin Cai1 site in 1 country31 target enrollmentMay 1, 2023
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ConditionsRectal CancerRecurrent

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Rectal Cancer
Sponsor
Xin Cai
Enrollment
31
Locations
1
Primary Endpoint
local control
Status
Not yet recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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)

Registry
clinicaltrials.gov
Start Date
May 1, 2023
End Date
December 31, 2026
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Xin Cai
Responsible Party
Sponsor Investigator
Principal Investigator

Xin Cai

Deputy chief physician

Shanghai Proton and Heavy Ion Center

Eligibility Criteria

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,
  • •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,
  • •space between the lesion to organ at risk (OARs) (bladder or digestive tract) was too close (\<5 mm).

Outcomes

Primary Outcomes

local control

Time Frame: Local control at 3 years after CIRT

local control rate of the lesion treated by CIRT

Secondary Outcomes

  • progression free survival(3 years after CIRT or patient died, measured erery 3 months after CIRT)
  • overall survival(3 years after CIRT or patient died, measured erery 3 months after CIRT)

Study Sites (1)

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