Proton and Carbon Ion Radiotherapy for Cervical Cancer

• Sponsor: Shanghai Proton and Heavy Ion Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT05141825
• Collaborator: (none)
• Enrollment: 16
• Arm: 1
• Actual Duration (Months): 70

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer	Radiation: proton and carbon ion radiotherapy	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Proton and Carbon Ion Radiotherapy for Cervical Cancer : A Retrospective Analysis
• Actual Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Oct 31, 2021
• Actual Study Completion Date: Oct 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: proton and carbon ion radiotherapy proton and carbon ion radiotherapy	Radiation: proton and carbon ion radiotherapy; proton and carbon ion radiotherapy

Outcome Measures

Primary Outcome Measures

1. 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

1. overall survival rate [3 years]

   overall survival rate

2. local control rate [3 years]

   local control rate

3. progression-free survival [3 years]

   progression-free survival

4. distant metastasis-free survival [3 years]

   distant metastasis-free survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Shanghai Proton and Heavy Ion Center

Investigators

• Principal Investigator: Qing Zhang, MD, Shanghai Proton and Heavy Ion Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhan Yu, physician of abdorminal and pelvic oncology department, Shanghai Proton and Heavy Ion Center
• ClinicalTrials.gov Identifier: NCT05141825
• Other Study ID Numbers: SPHIC-TR-CERC-2021-01
• First Posted: Dec 2, 2021
• Last Update Posted: Dec 2, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zhan Yu, physician of abdorminal and pelvic oncology department, Shanghai Proton and Heavy Ion Center: proton and carbon ion radiotherapy
• Additional relevant MeSH terms: Uterine Cervical Neoplasms

Study Results

No Results Posted as of Dec 2, 2021