Proton and Carbon Ion Radiotherapy for Cervical Cancer

Cervical Cancer Clinical Trial

Official title:

Proton and Carbon Ion Radiotherapy for Cervical Cancer : A Retrospective Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05141825
• Other study ID #: SPHIC-TR-CERC-2021-01
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: October 31, 2021

Study information

• Verified date: November 2021
• Source: Shanghai Proton and Heavy Ion Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Radiation:
• proton and carbon ion radiotherapy
proton and carbon ion radiotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Proton and Heavy Ion Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	through study completion, an average of 1 year
Secondary	overall survival rate	overall survival rate	3 years
Secondary	local control rate	local control rate	3 years
Secondary	progression-free survival	progression-free survival	3 years
Secondary	distant metastasis-free survival	distant metastasis-free survival	3 years