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Not yet recruiting NCT05807984

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

Phase II Interventional Rectal Cancer Recurrent

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Carbon ion radiation therapy DT: 74Gy/20 fractions.
Who it may be relevant to
Registry conditions: Rectal Cancer, Recurrent. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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)

Interventions

  • 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

Primary outcome measures

  • local control [Time frame: Local control at 3 years after CIRT]
Secondary outcome measures (2)
  • overall survival [Time frame: 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]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Proton and Heavy ion center — Shanghai

Identifiers

NCT: NCT05807984 · SPHIC-TR-CRC2021-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗