Proton and Carbon Ion Radiotherapy for Cervical Cancer

Not Applicable

Completed

• Conditions: Cervical Cancer
• Interventions: Radiation: proton and carbon ion radiotherapy

• Registration Number: NCT05141825
• Lead Sponsor: Shanghai Proton and Heavy Ion Center

Brief Summary

The aim of this study is to evaluate the toxicity and tolerance of proton and carbon ion radiotherapy (PCRT) for cervical cancer.

Detailed Description

To retrospectively analyze cervical cancer patients received radical proton and carbon radiotherapy in our center. The acute and late toxicities, overall survival (OS), local control rate (LC), progression-free survival (PFS) and distant metastasis-free survival (DMFS) were analyzed.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31
• Status Verified: 2021-11
• Study First Submitted: 2021-11-23
• Study First Submitted QC: 2021-11-30
• Last Update Submitted: 2021-11-30
• Study First Posted: 2021-12-02
• Last Update Posted: 2021-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

Inclusion Criteria

1. . histologically diagnosis of squamous cell carcinoma of the cervix;
2. . International Federation of Gynecology and Obstetrics (FIGO) stage (2014) IB2 - IIIB, without rectum invasion; or FIGO stage IA - IB1, who refused surgery or were contraindication for surgery due to comorbidity diseases;
3. . received proton and carbon ion radiotherapy (PCRT) with or without chemotherapy for curative intention;
4. . Follow-up data available.

Exclusion Criteria

1. a previous history of other malignancy;
2. squamous cell carcinoma of the cervix patients who had received surgery;
3. rectum was invaded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
proton and carbon ion radiotherapy	proton and carbon ion radiotherapy	proton and carbon ion radiotherapy

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	through study completion, an average of 1 year	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Secondary Outcome Measures

Name	Time	Method
overall survival rate	3 years	overall survival rate
local control rate	3 years	local control rate
progression-free survival	3 years	progression-free survival
distant metastasis-free survival	3 years	distant metastasis-free survival