Back to resultsOnline Adaptive Radiotherapy for Postoperative Treatment of Endometrial and Cervical Cancer
Primary Purpose
Uterine Cervical Neoplasm, Endometrial Neoplasms
Status
Active
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Online adaptive radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Cervical Neoplasm focused on measuring Uterine Cervical Neoplasm, Endometrial Neoplasms, Online Adaptive Radiotherapy, Adjuvant Radiotherapy
Eligibility Criteria
Inclusion Criteria: Patients must be informed of the investigational nature of this study and give written informed consent before treatment. 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). Pathological findings indicate risk factors and adjuvant radiotherapy are prescribe. Karnofsky score ≥ 70. Subjects aged ≥ 18 years and ≤ 70 years. No evidence of para-aortic metastatic lymph nodes. No contraindications to CT scanning. Subjects must be able to cooperate in completing the entire study. Adequate marrow: neutrophile granulocyte count ≥1.5*10^9/L, hemoglobin ≥ 80 g/L, platelet count ≥100*10^9/L. 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: Subjects who have received prior pelvic radiotherapy. Subjects with other primary malignancies. Subjects with contraindications to radiotherapy, as determined by the investigators. 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. Active infection with fever. Active inflammatory bowel disease.
Sites / Locations
- Peking Union Medical College Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Online Adaptive Radiotherapy
Arm Description
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.
Outcomes
Primary Outcome Measures
Physician-reported acute toxicity
Physician-reported acute toxicity evaluated with Common Terminology Criteria for Adverse Events (CTCAE) 5.0
Secondary Outcome Measures
Late toxicity evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme
Evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme
The dose coverage of target volume as assessed by planing tumor volume V100%
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.
Target automatically contouring accuracy
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.
Organs at risk contouring accuracy
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.
Full Information
NCT ID
NCT05869123
First Posted
May 11, 2023
Last Updated
June 3, 2023
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05869123
Brief Title
Online Adaptive Radiotherapy for Postoperative Treatment of Endometrial and Cervical Cancer
Official Title
A Prospective Study to Evaluate Online Adaptive Radiotherapy in Postoperative Treatment of Endometrial and Cervical With Reduced Margin
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 20, 2022 (Actual)
Primary Completion Date
March 3, 2023 (Actual)
Study Completion Date
March 3, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Neoplasm, Endometrial Neoplasms
Keywords
Uterine Cervical Neoplasm, Endometrial Neoplasms, Online Adaptive Radiotherapy, Adjuvant Radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Online Adaptive Radiotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Online adaptive radiotherapy
Intervention Description
PTV with 5 margins covers CTV
Primary Outcome Measure Information:
Title
Physician-reported acute toxicity
Description
Physician-reported acute toxicity evaluated with Common Terminology Criteria for Adverse Events (CTCAE) 5.0
Time Frame
From the start of treatment to 3 months after treatment
Secondary Outcome Measure Information:
Title
Late toxicity evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme
Description
Evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme
Time Frame
2-year
Title
The dose coverage of target volume as assessed by planing tumor volume V100%
Description
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.
Time Frame
Through study completion, an average of five month
Title
Target automatically contouring accuracy
Description
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.
Time Frame
Through study completion, an average of five month
Title
Organs at risk contouring accuracy
Description
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.
Time Frame
Through study completion, an average of five month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must be informed of the investigational nature of this study and give written informed consent before treatment.
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).
Pathological findings indicate risk factors and adjuvant radiotherapy are prescribe.
Karnofsky score ≥ 70.
Subjects aged ≥ 18 years and ≤ 70 years.
No evidence of para-aortic metastatic lymph nodes.
No contraindications to CT scanning.
Subjects must be able to cooperate in completing the entire study.
Adequate marrow: neutrophile granulocyte count ≥1.5*10^9/L, hemoglobin ≥ 80 g/L, platelet count ≥100*10^9/L.
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:
Subjects who have received prior pelvic radiotherapy.
Subjects with other primary malignancies.
Subjects with contraindications to radiotherapy, as determined by the investigators.
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.
Active infection with fever.
Active inflammatory bowel disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fuquan Zhang, M.D.
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
34301300
Citation
de Jong R, Visser J, van Wieringen N, Wiersma J, Geijsen D, Bel A. Feasibility of Conebeam CT-based online adaptive radiotherapy for neoadjuvant treatment of rectal cancer. Radiat Oncol. 2021 Jul 23;16(1):136. doi: 10.1186/s13014-021-01866-7.
Results Reference
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PubMed Identifier
35768023
Citation
Schiff JP, Stowe HB, Price A, Laugeman E, Hatscher C, Hugo GD, Badiyan SN, Kim H, Robinson CG, Henke LE. In Silico Trial of Computed Tomography-Guided Stereotactic Adaptive Radiation Therapy (CT-STAR) for the Treatment of Abdominal Oligometastases. Int J Radiat Oncol Biol Phys. 2022 Dec 1;114(5):1022-1031. doi: 10.1016/j.ijrobp.2022.06.078. Epub 2022 Jun 26.
Results Reference
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Online Adaptive Radiotherapy for Postoperative Treatment of Endometrial and Cervical Cancer
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