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

NCT ID: NCT05807984

Last Updated: 2023-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2026-12-31

Brief Summary

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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)

Detailed Description

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Conditions

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Rectal Cancer Recurrent

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

carbon ion therapy
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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carbon ion therapy for unresectable local recurrent rectal cancer

Group Type EXPERIMENTAL

Carbon ion radiation therapy DT: 74Gy/20 fractions

Intervention Type RADIATION

patients with unresectable local recurrent rectal cancer will be treated with carbon ion radiation therapy as re-irradiation

Interventions

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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

Intervention Type RADIATION

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xin Cai

OTHER

Sponsor Role lead

Responsible Party

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Xin Cai

Deputy chief physician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Shanghai Proton and Heavy ion center

Shanghai, Pudong, China

Site Status

Countries

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China

Central Contacts

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Xin Cai, Doctor

Role: CONTACT

+86 13901601072

Zheng Wang, Doctor

Role: CONTACT

+86 021-38296666

Facility Contacts

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Xin Cai, Doctor

Role: primary

+86 13901601072

Other Identifiers

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SPHIC-TR-CRC2021-01

Identifier Type: -

Identifier Source: org_study_id

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