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

Xin Cai

Status and phase: Not yet enrolling; Phase 2

Conditions: Recurrent; Rectal Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05807984

SPHIC-TR-CRC2021-01

Details and patient eligibility

About

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)

Enrollment: 31 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

carbon ion therapy for unresectable local recurrent rectal cancer

Experimental group

Treatment:

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