Online Adaptive Radiotherapy Cervical Cancer With Reduced Margin for Cervical Cancer

November 7, 2023 updated by: Peking Union Medical College Hospital

A Prospective Study to Evaluate Online Adaptive Radiotherapy in Cervical Cancer With Reduced Margin

Online adaptive radiotherapy (oART) has demonstrated to be feasible to reduce planning target volume (PTV) margins for cervical cancer. To explore the value of reduced margins in oART for 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 cervical cancer could decrease toxicity and achieve more accurate dosimetric coverage. A dose of 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.

Study Type

Interventional

Enrollment (Actual)

30

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 Contact

  • Name: Fuquan Zhang, M.D.
  • Phone Number: +86 13311360431
  • Email: zhangfq@pumch.cn

Study Contact Backup

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. Age ≥18 years and ≤ 75 years.
  3. Patients with newly histologically confirmed cervical cancer, including squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma, et al.
  4. No evidence of para-aortic metastatic lymph nodes (MLNs) and inguinal lymph nodes on CT, MRI or positron emission tomograph (PET)/CT.
  5. No contraindications to CT scanning.
  6. No evidence of distant metastasis (FIGO stage IVB).
  7. Adequate marrow: neutrophile granulocyte count ≥1.5*10^9/L, hemoglobin ≥ 80 g/L, platelet count ≥100*10^9/L.
  8. 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. With common iliac MLNs.
  2. Tumor extended to the lower third of the vagina.
  3. Tumor spread to mucosa of the bladder or rectum.
  4. Prior surgery (including pelvic or para-aortic lymph nodes resection, except for tumor biopsy), radiotherapy or chemotherapy to primary tumor or nodes.
  5. Prior malignancy.
  6. History of previous radiotherapy to the abdomen or pelvis.
  7. Pregnancy or lactation.
  8. Active inflammatory bowel disease, or history of severe stomach or duodenal ulcer.
  9. Active infection with fever.
  10. Patients with unacceptable risk that intracavitary brachytherapy can not be conducted.
  11. 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.

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 5-10mm PTV margin. The CTV contours of the following areas: gross tumor volume (GTV), cervix (if not already encompassed by the GTV), uterus, parametria, ovaries, vaginal tissue, obturator nodal chain, internal iliac nodal chain, external iliac nodal chain, presacral nodal chain and common iliac nodal chain. The upper border of CTV is at the level of aortic bifurcation. A dose of 50.4Gy is delivered to CTV with online adaptive radiotherapy.
Radiation: online adaptive radiotherapy
PTV with 5-10 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
Patient-reported acute toxicity
Time Frame: From the start of treatment to 3 months after treatment
Patient-reported acute toxicity evaluated with European Organization for Research and Treatment of Cancer Quality of Life C30 (EORTC QLQ-C30) 3.0 questionnaire
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 irradiated doses of organs at risk
Time Frame: Through study completion, an average of eight month
The organs at risk includes bladder, rectum, bone marrow, femur head left, femur head right and bowel that may be irradiated near the target volume
Through study completion, an average of eight month
The dose coverage of target volume as assessed by planing tumor volume V100%
Time Frame: Through study completion, an average of eight 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 eight month
Target volume contouring accuracy
Time Frame: Through study completion, an average of eight 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 eight month
Response evaluation evaluated with RECIST 1.1
Time Frame: One month after treatment
Evaluated with RECIST 1.1
One month after treatment
Movement of the uterus during per radiotherapy fractions
Time Frame: Through study completion, an average of eight month
The pre- and post-treatment CBCT scans will be obtained during per treatment. The uterus intra-fractional motion were evaluated by comparison of uterus centroid from pre-treatment CBCT and uterus centroid from post-treatment images.
Through study completion, an average of eight month
Movement of the cervix during per radiotherapy fractions
Time Frame: Through study completion, an average of eight month
The pre- and post-treatment CBCT scans will be obtained during per treatment. The cervix intra-fractional motion were evaluated by comparison of cervix centroid from pre-treatment CBCT and cervix centroid from post-treatment images.
Through study completion, an average of eight month
Progression-free survival
Time Frame: 2-year
Progression-free survival is defined as the time from randomization to disease progression or death from any cause, whichever is first.
2-year
Personalized margin for cervical cancer
Time Frame: Six month after treatment
Pre- and post-treatment images are uploaded to the online adaptive radiotherapy simulator to re-delineate the target volume and determine the personalized margin range.
Six month after treatment

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)

February 2, 2023

Primary Completion (Actual)

November 6, 2023

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

April 26, 2023

First Submitted That Met QC Criteria

May 19, 2023

First Posted (Actual)

May 30, 2023

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pumch-ART2

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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