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Trial Title:
Re-irradiation Therapy of Locally Recurrent Rectal Cancer With Carbon Ion
NCT ID:
NCT05807984
Condition:
Rectal Cancer
Recurrent
Conditions: Official terms:
Rectal Neoplasms
Recurrence
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
carbon ion therapy
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Carbon ion radiation therapy DT: 74Gy/20 fractions
Description:
patients with unresectable local recurrent rectal cancer will be treated with carbon ion
radiation therapy as re-irradiation
Arm group label:
carbon ion therapy for unresectable local recurrent rectal cancer
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)
Criteria for 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).
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Proton and Heavy ion center
Address:
City:
Shanghai
Zip:
201321
Country:
China
Contact:
Last name:
Xin Cai, Doctor
Phone:
+86 13901601072
Email:
xin.cai@sphic.org.cn
Start date:
May 1, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Xin Cai
Agency class:
Other
Source:
Shanghai Proton and Heavy Ion Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05807984
