Back to resultsRe-irradiation Therapy of Locally Recurrent Rectal Cancer With Carbon Ion
Primary Purpose
Rectal Cancer, Recurrent
Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Carbon ion radiation therapy DT: 74Gy/20 fractions
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer
Eligibility Criteria
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).
Sites / Locations
- Shanghai Proton and Heavy ion center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
carbon ion therapy for unresectable local recurrent rectal cancer
Arm Description
Outcomes
Primary Outcome Measures
local control
local control rate of the lesion treated by CIRT
Secondary Outcome Measures
overall survival
survival rate after CIRT
progression free survival
progression free survival rate after CIRT
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05807984
Brief Title
Re-irradiation Therapy of Locally Recurrent Rectal Cancer With Carbon Ion
Official Title
A Prospective Phase II Clinical Study of Carbon Ion Re-irradiation in Unresectable Locally Recurrent Rectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xin Cai
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer, Recurrent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
carbon ion therapy
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
carbon ion therapy for unresectable local recurrent rectal cancer
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Carbon ion radiation therapy DT: 74Gy/20 fractions
Intervention Description
patients with unresectable local recurrent rectal cancer will be treated with carbon ion radiation therapy as re-irradiation
Primary Outcome Measure Information:
Title
local control
Description
local control rate of the lesion treated by CIRT
Time Frame
Local control at 3 years after CIRT
Secondary Outcome Measure Information:
Title
overall survival
Description
survival rate after CIRT
Time Frame
3 years after CIRT or patient died, measured erery 3 months after CIRT
Title
progression free survival
Description
progression free survival rate after CIRT
Time Frame
3 years after CIRT or patient died, measured erery 3 months after CIRT
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Cai, Doctor
Phone
+86 13901601072
Email
xin.cai@sphic.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zheng Wang, Doctor
Phone
+86 021-38296666
Email
zheng.wang@sphic.org.cn
Facility Information:
Facility Name
Shanghai Proton and Heavy ion center
City
Shanghai
State/Province
Pudong
ZIP/Postal Code
201321
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Cai, Doctor
Phone
+86 13901601072
Email
xin.cai@sphic.org.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Re-irradiation Therapy of Locally Recurrent Rectal Cancer With Carbon Ion
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