Proton and Carbon Ion Radiotherapy for Cervical Cancer

NCT05141825 | Completed DMC

• 1 other identifier: SPHIC-TR-CERC-2021-01
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Cervical Cancer

Keywords

proton and carbon ion radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• overall survival rate

  3 years

• local control rate

  3 years

• progression-free survival

  3 years

• distant metastasis-free survival

  3 years

Study Arms (1)

proton and carbon ion radiotherapy

EXPERIMENTAL

proton and carbon ion radiotherapy

Radiation: proton and carbon ion radiotherapy

Interventions

proton and carbon ion radiotherapy RADIATION

proton and carbon ion radiotherapy

proton and carbon ion radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically diagnosis of squamous cell carcinoma of the cervix;
• 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;
• received proton and carbon ion radiotherapy (PCRT) with or without chemotherapy for curative intention;
• Follow-up data available.

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Proton and Heavy Ion Center: lead

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Protons; Heavy Ion Radiotherapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons; Elementary Particles; Physical Phenomena; Radiotherapy; Therapeutics

Study Officials

• Qing Zhang, MD

  Shanghai Proton and Heavy Ion Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physician of abdorminal and pelvic oncology department

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 2, 2021
• Study Start: January 1, 2016
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: December 2, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share