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Completed

NCT Number: NCT05141825

Proton and Carbon Ion Radiotherapy for Cervical Cancer

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • . 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.

Exclusion criteria

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

Treatment and study plan

proton and carbon ion radiotherapy

Radiation

proton and carbon ion radiotherapy

Primary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: through study completion, an average of 1 year

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Secondary outcomes

  1. overall survival rate

    Time frame: 3 years

    overall survival rate

  2. local control rate

    Time frame: 3 years

    local control rate

  3. progression-free survival

    Time frame: 3 years

    progression-free survival

  4. distant metastasis-free survival

    Time frame: 3 years

    distant metastasis-free survival

Sponsors and collaborators

Lead sponsor

Shanghai Proton and Heavy Ion Center

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Dec 2, 2021
Registry last updated
Dec 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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