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

April 7, 2023 updated by: Xin Cai

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

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)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

31

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Pudong
      • Shanghai, Pudong, China, 201321
        • Shanghai Proton and Heavy Ion Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
local control
Time Frame: Local control at 3 years after CIRT
local control rate of the lesion treated by CIRT
Local control at 3 years after CIRT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 3 years after CIRT or patient died, measured erery 3 months after CIRT
survival rate after CIRT
3 years after CIRT or patient died, measured erery 3 months after CIRT
progression free survival
Time Frame: 3 years after CIRT or patient died, measured erery 3 months after CIRT
progression free survival rate after CIRT
3 years after CIRT or patient died, measured erery 3 months after CIRT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xin Cai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2026

Study Registration Dates

First Submitted

February 16, 2023

First Submitted That Met QC Criteria

April 7, 2023

First Posted (Actual)

April 11, 2023

Study Record Updates

Last Update Posted (Actual)

April 11, 2023

Last Update Submitted That Met QC Criteria

April 7, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPHIC-TR-CRC2021-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rectal Cancer

Clinical Trials on Carbon ion radiation therapy DT: 74Gy/20 fractions

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe