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

• Sponsor: Xin Cai (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05807984
• Collaborator: (none)
• Enrollment: 31
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 44
• Patients Per Site Per Month: 0.7

Study Details

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)

Condition or Disease	Intervention/Treatment	Phase
Rectal Cancer; Recurrent	Radiation: Carbon ion radiation therapy DT: 74Gy/20 fractions	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 31 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: carbon ion therapycarbon ion therapy
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective Phase II Clinical Study of Carbon Ion Re-irradiation in Unresectable Locally Recurrent Rectal Cancer
• Anticipated Study Start Date: May 1, 2023
• Anticipated Primary Completion Date: Dec 31, 2025
• Anticipated Study Completion Date: Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: carbon ion therapy for unresectable local recurrent rectal cancer	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

Outcome Measures

Primary Outcome Measures

1. local control [Local control at 3 years after CIRT]

   local control rate of the lesion treated by CIRT

Secondary Outcome Measures

1. overall survival [3 years after CIRT or patient died, measured erery 3 months after CIRT]

   survival rate after CIRT

2. progression free survival [3 years after CIRT or patient died, measured erery 3 months after CIRT]

   progression free survival rate after CIRT

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 1. pathologically confirmed rectal adenocarcinoma (including mucinous adenocarcinoma and signet-ring cell carcinoma) and LRRC confirmed by biopsy or clinical diagnosis,
• 1. received a radical operation for their primary tumor and regional lymph nodes,
• 1. received chemo-radiation or radiation in pelvic before CIRT,
• 1. received re-irradiation by CIRT after their pelvic radiotherapy.

Exclusion Criteria:

• 1. received more than once prior radiotherapy in the same treatment field,
• 1. time to the last radiotherapy was <1 year,
• 1. space between the lesion to organ at risk (OARs) (bladder or digestive tract) was too close (<5 mm).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Proton and Heavy ion center	Shanghai	Pudong	China	201321

Sponsors and Collaborators

• Xin Cai

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xin Cai, Deputy chief physician, Shanghai Proton and Heavy Ion Center
• ClinicalTrials.gov Identifier: NCT05807984
• Other Study ID Numbers: SPHIC-TR-CRC2021-01
• First Posted: Apr 11, 2023
• Last Update Posted: Apr 11, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Rectal Neoplasms; Recurrence

Study Results

No Results Posted as of Apr 11, 2023