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

NCT05807984 | Not Yet Recruiting Phase 2

• 1 other identifier: SPHIC-TR-CRC2021-01
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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)

Conditions

Rectal Cancer; Recurrent

Outcome Measures

Primary Outcomes (1)

• local control

  local control rate of the lesion treated by CIRT

  Local control at 3 years after CIRT

Secondary Outcomes (2)

• overall survival

  3 years after CIRT or patient died, measured erery 3 months after CIRT

• progression free survival

  3 years after CIRT or patient died, measured erery 3 months after CIRT

Study Arms (1)

carbon ion therapy for unresectable local recurrent rectal cancer

EXPERIMENTAL

Radiation: Carbon ion radiation therapy DT: 74Gy/20 fractions

Interventions

Carbon ion radiation therapy DT: 74Gy/20 fractions RADIATION

patients with unresectable local recurrent rectal cancer will be treated with carbon ion radiation therapy as re-irradiation

carbon ion therapy for unresectable local recurrent rectal cancer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.

You may not qualify if:

• \) 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).

Sponsors & Collaborators

• Xin Cai: lead

Study Sites (1)

Shanghai Proton and Heavy ion center

Shanghai, Pudong, 201321, China

Location

MeSH Terms

Conditions

Rectal Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xin Cai, Doctor

CONTACT

+86 13901601072; xin.cai@sphic.org.cn

Zheng Wang, Doctor

CONTACT

+86 021-38296666; zheng.wang@sphic.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy chief physician

Model Details: carbon ion therapy

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: April 11, 2023
• Study Start: May 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 11, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)