Online Adaptive Radiotherapy for Postoperative Treatment of Endometrial and Cervical Cancer

June 3, 2023 updated by: Peking Union Medical College Hospital

A Prospective Study to Evaluate Online Adaptive Radiotherapy in Postoperative Treatment of Endometrial and Cervical With Reduced Margin

Online adaptive radiotherapy (oART) has demonstrated to be feasible to reduce planning target volume (PTV) margins for postoperative treatment of endometrial and cervical cancer. To explore the value of reduced margins in oART for postoperative treatment of endometrial and cervical cancer, we conducted a prospective clinical trial to determine the clinical efficacy and toxicity of reduced margins.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an investigator-initiated efficacious, single-center, open-label clinical trial study. This study hypothesizes that the use of reduced PTV margins in oART for postoperative treatment of endometrial and cervical cancer could decrease toxicity and achieve more accurate dosimetric coverage. A dose of 45 or 50.4 Gy is delivered to clinical target volume (CTV) with reduced margin oART. Patients receive cisplatin based concurrent chemotherapy. The primary endpoint is acute toxicity. The first 10 patients were included in the study that have demonstrated the feasibility of reducing the margin (ClinicalTrials.gov ID: NCT05682950).

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2
  • Phase 1

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
      • Beijing, Beijing, China, 100730
        • 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

Description

Inclusion Criteria:

  1. Patients must be informed of the investigational nature of this study and give written informed consent before treatment.
  2. Postoperative endometrial and cervical cancer patients with pathologically confirmed no residual tumor at the resection margin and no evidence of distant metastasis (FIGO stage IVB).
  3. Pathological findings indicate risk factors and adjuvant radiotherapy are prescribe.
  4. Karnofsky score ≥ 70.
  5. Subjects aged ≥ 18 years and ≤ 70 years.
  6. No evidence of para-aortic metastatic lymph nodes.
  7. No contraindications to CT scanning.
  8. Subjects must be able to cooperate in completing the entire study.
  9. Adequate marrow: neutrophile granulocyte count ≥1.5*10^9/L, hemoglobin ≥ 80 g/L, platelet count ≥100*10^9/L.
  10. Normal liver and kidney function: Creatinine (Cr) < 1.5 mg/dl, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) < 2*upper limit of normal (ULN).

Exclusion Criteria:

  1. Subjects who have received prior pelvic radiotherapy.
  2. Subjects with other primary malignancies.
  3. Subjects with contraindications to radiotherapy, as determined by the investigators.
  4. Any severe disease which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control, and emotional disturbance.
  5. Active infection with fever.
  6. Active inflammatory bowel disease.

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Online Adaptive Radiotherapy
Patients receive online adaptive radiotherapy with 5mm PTV margin. The CTV-N covered pelvic lymph nodes (common, internal and external iliac, obturator, and presacral) and CTV-V covered proximal vagina and any paravaginal or retracted parametrial tissue. A dose of 45 or 50.4Gy is delivered to CTV with online adaptive radiotherapy.
Radiation: Online adaptive radiotherapy
PTV with 5 margins covers CTV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physician-reported acute toxicity
Time Frame: From the start of treatment to 3 months after treatment
Physician-reported acute toxicity evaluated with Common Terminology Criteria for Adverse Events (CTCAE) 5.0
From the start of treatment to 3 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Late toxicity evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme
Time Frame: 2-year
Evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme
2-year
The dose coverage of target volume as assessed by planing tumor volume V100%
Time Frame: Through study completion, an average of five month
Planing tumor volume V100%, defined as the planing tumor volume receiving at least 100% of the prescribed dose (V100%), is used to evaluate the dose coverage of target volume.
Through study completion, an average of five month
Target automatically contouring accuracy
Time Frame: Through study completion, an average of five month
For every target in each fraction, the evaluation of accuracy for target contouring are categorized as follow: no edits, minor edits, moderate edits, major edits and not applicable.
Through study completion, an average of five month
Organs at risk contouring accuracy
Time Frame: Through study completion, an average of five month
For every organs at risk in each fraction, the evaluation of accuracy for organs at risk contouring are categorized as follows: no edits, minor edits, moderate edits, major edits and not applicable.
Through study completion, an average of five month

Collaborators and Investigators

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

Sponsor

Peking Union Medical College Hospital

Investigators

  • Study Chair: Fuquan Zhang, M.D., Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 20, 2022

Primary Completion (Actual)

March 3, 2023

Study Completion (Estimated)

March 3, 2025

Study Registration Dates

First Submitted

May 11, 2023

First Submitted That Met QC Criteria

May 11, 2023

First Posted (Actual)

May 22, 2023

Study Record Updates

Last Update Posted (Actual)

June 6, 2023

Last Update Submitted That Met QC Criteria

June 3, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pumch-ART-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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