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NCT Number: NCT05807984

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

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)

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Primary outcomes

  1. local control

    Time frame: Local control at 3 years after CIRT

    local control rate of the lesion treated by CIRT

Secondary outcomes

  1. overall survival

    Time frame: 3 years after CIRT or patient died, measured erery 3 months after CIRT

    survival rate after CIRT

  2. progression free survival

    Time frame: 3 years after CIRT or patient died, measured erery 3 months after CIRT

    progression free survival rate after CIRT

Study contacts

Contact information is provided by the study sponsor or research team.

Xin Cai, Doctor

CONTACT

[email protected]

+86 13901601072

Zheng Wang, Doctor

CONTACT

[email protected]

+86 021-38296666

Sponsors and collaborators

Lead sponsor

Xin Cai

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Apr 11, 2023
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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