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

ConditionsRectal CancerRecurrent
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorXin Cai

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

31 Participants
are divided into 1 treatment group
Group A: carbon ion therapy for unresectable local recurrent rectal cancerExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

local control

local control rate of the lesion treated by CIRT

Time frame
Local control at 3 years after CIRT

Secondary outcomes

1

overall survival

survival rate after CIRT

Time frame
3 years after CIRT or patient died, measured erery 3 months after CIRT
2

progression free survival

progression free survival rate after CIRT

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xin Cai

Lead sponsor

Shanghai Proton and Heavy Ion Center

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: