RT for Cervical Adenocarcinoma/adenosquamous Carcinoma

December 16, 2024 updated by: yanjunfang, Peking Union Medical College Hospital

Evaluation of the Treatment Response and Prognosis of Cervical Adenocarcinoma/adenosquamous Carcinoma After Radiotherapy: a Retrospective Study

The purpose of this study was to retrospectively analyze patients with cervical adenocarcinoma/adenosquamous carcinoma who had been admitted to our hospital. Approximately 500 cases of cervical adenocarcinoma were planned to be included, summarize the disease characteristics, treatment regimens, and recurrence patterns of the patients, and analyze the association between treatment regimens and recurrence patterns and prognosis.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

This study is a retrospective analysis. The keywords "cervical adenocarcinoma" and "cervical adenosquamous carcinoma" were used to search for patients with cervical adenocarcinoma and cervical adenosquamous carcinoma admitted to the Department of Radiotherapy, Peking Union Medical College Hospital from 2009 to 2024. The clinical information, pathological information, and treatment methods of the patients in the medical records were collected, and the date of death, cancer recurrence, and metastasis were confirmed by querying medical records or conducting telephone interviews. The included cases were divided into the radical surgery group and the concurrent chemoradiotherapy group according to the treatment mode. The pathological types were reclassified according to the IECC 2018 standards, and the associations between pathological types, treatment regimens, recurrence patterns (local recurrence, distant metastasis, recurrence within the irradiation field, recurrence outside the irradiation field), and prognosis were analyzed. For patients with residual local cervical tumors after synchronous chemoradiotherapy or recurrence within the field after radiotherapy, the previous genetic test results of the patients were retrieved, their genomic characteristics were analyzed, and compared with the TCGA database. If the patient has not undergone genetic testing before, pathological sections of the patient will be obtained from our hospital for whole exome sequencing, and the testing items include.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Female patinets diagnosed with cervical adenocarcinoma or adenosquamous carcinoma receiving CCRT or RT after complete surgery

Description

Inclusion Criteria:

a) Pathological diagnosis of cervical adenocarcinoma; b) Age 18-80 years old; c) Karnofsky score≥60 points; e) Complete blood count, and comprehensive metabolic panel meet the conditions for CCRT or RT after surgery; f) No metal implants in the body, and can perform MRI examination; g) Willing to participate in this study and provide written informed consent. -

Exclusion Criteria:

  1. Patients who have received pelvic radiotherapy before;
  2. Patients whose target tumors have been treated before (chemotherapy, immunotherapy, surgical treatment, etc.);
  3. Allergy to iodine contrast agent;
  4. Participating in other clinical studies that may affect the results of this study (determined by the principal investigator);

f) Serious diseases that may significantly affect compliance with clinical trials, such as unstable heart disease, kidney disease, chronic hepatitis, poorly controlled diabetes, and mental illness that require treatment; g) Other situations that the investigator believes are not suitable for participation in this clinical study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Radical surgery group
Patients who received radical surgery for cervical cancer in Peking Union Medical College Hospital
Concurrent chemoradiotherapy group
Patients who received concurrent chemoradiotherapy in Peking Union Medical College Hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local control rate
Time Frame: local control rates at 2 years or 3 years after the initial treatment
Tumor control rate in the cohort after treatment
local control rates at 2 years or 3 years after the initial treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progress free survival
Time Frame: 2 years after initial treatment
the time from initial treatment to disease progression or death from any cause.
2 years after initial treatment
Overall survival
Time Frame: 2 years after initial treatment
The length of time from the start of initial treatment to death or the last followup
2 years after initial treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

December 16, 2024

First Submitted That Met QC Criteria

December 16, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 16, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATTRACT-Retro

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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