Re-irradiation Therapy of Locally Recurrent Rectal Cancer With Carbon Ion

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05807984
• Other study ID #: SPHIC-TR-CRC2021-01
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 1, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2023
• Source: Shanghai Proton and Heavy Ion Center
• Contact: Xin Cai, Doctor
• Phone: +86 13901601072
• Email: xin.cai[@]sphic.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• 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).

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms
• Recurrence
• Recurrent

Intervention

Radiation:
• Carbon ion radiation therapy DT: 74Gy/20 fractions
patients with unresectable local recurrent rectal cancer will be treated with carbon ion radiation therapy as re-irradiation

Locations

Country	Name	City	State
China	Shanghai Proton and Heavy ion center	Shanghai	Pudong

Sponsors (1)

Lead Sponsor	Collaborator
Xin Cai

Country where clinical trial is conducted

China, 

Outcome

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