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Optimal Margin Evaluation of Online Adaptive Radiotherapy for Postoperative Treatment of Endometrial and Cervical Cancer

Primary Purpose

Uterine Cervical Neoplasm, Endometrial Neoplasms

Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
online adaptive radiotherapy
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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. The CTV contours of the following areas: vaginal cuff, 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 45-50.4Gy is delivered to CTV with online adaptive radiotherapy.

Outcomes

Primary Outcome Measures

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.
A minimum PTV margin could encompass CTV
Expansions were applied to the pretreatment PTV to assess required minimum margin required to encompass the postreatment CTV.

Secondary Outcome Measures

Safety for treatment as assessed by organs at risk doses
Safety for treatment was mainly evaluated by the organs at risk doses, including bladder, rectum, bone marrow, etc
Number of participants with acute toxicity as assessed by CTCAE 5.0
Evaluated with CTCAE 5.0
Adaptive time data
For each treatment in each fraction, adaptive time was recorded from first cone beam computed tomography (CBCT) to the selection of the preferred plan for the treatment.
Target 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.
Late toxicity evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme
Evaluated every three months with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme

Full Information

First Posted
December 14, 2022
Last Updated
May 5, 2023
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05682950
Brief Title
Optimal Margin Evaluation of Online Adaptive Radiotherapy for Postoperative Treatment of Endometrial and Cervical Cancer
Official Title
A Prospective Study to Evaluate Optimal Margin of Iterative Cone-beam Computed Tomography Guided Online Adaptive Radiotherapy for Postoperative Treatment of Endometrial and Cervical Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 12, 2022 (Actual)
Primary Completion Date
February 6, 2023 (Actual)
Study Completion Date
February 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 has demonstrated to be feasible to reduce inter-fractional radiotherapy errors as it re-optimizes treatment plan every fraction. To investigate the extent and value of margin reduction,we conduct a prospective clinical trial to determine the optimal margin and toxicity of smaller margin.
Detailed Description
This is a prospective phase II clinical trial with an anticipated total of more than 380 radiotherapy fractions of 15 patients to evaluate optimal margin of iterative cone-beam computed tomography(iCBCT) guided online adaptive radiotherapy (oART) for postoperative treatment of endometrial and cervical cancer. Postoperative endometrial and cervical cancer patients with following characteristics are included in the present study:(a)underwent radical surgery (b)no residual tumor at the resection margin by postoperative pathology(c)pathological findings indicate risk factors but no metastasis (d) adjuvant radiotherapy are prescribe (e)without evidence of para-aortic metastatic lymph nodes. Five patients (almost 125 fractions)treated with oART have the target volume contoured on pre-treatment iCBCTs and end-treatment iCBCTs. Anterior-posterior, lateral, and superior-inferior shifts were calculated and the average shift in all directions was calculated. A clinical target volume (CTV) to planing tumor volume (PTV) expansion is determined and verifies on a validation cohort of 10 patients (almost 250 fractions) treated with oART. Record acute toxicity from the start of treatment to 3 months after treatment.

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 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Online Adaptive Radiotherapy
Arm Type
Experimental
Arm Description
Patients receive online adaptive radiotherapy. The CTV contours of the following areas: vaginal cuff, 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 45-50.4Gy is delivered to CTV with online adaptive radiotherapy.
Intervention Type
Radiation
Intervention Name(s)
online adaptive radiotherapy
Intervention Description
CTV covers pelvis.
Primary Outcome Measure Information:
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, total an average of six month
Title
A minimum PTV margin could encompass CTV
Description
Expansions were applied to the pretreatment PTV to assess required minimum margin required to encompass the postreatment CTV.
Time Frame
Through study completion, toral an average of six month
Secondary Outcome Measure Information:
Title
Safety for treatment as assessed by organs at risk doses
Description
Safety for treatment was mainly evaluated by the organs at risk doses, including bladder, rectum, bone marrow, etc
Time Frame
Through study completion, total an average of six month
Title
Number of participants with acute toxicity as assessed by CTCAE 5.0
Description
Evaluated with CTCAE 5.0
Time Frame
From the start of treatment to 3 months after treatment
Title
Adaptive time data
Description
For each treatment in each fraction, adaptive time was recorded from first cone beam computed tomography (CBCT) to the selection of the preferred plan for the treatment.
Time Frame
Through study completion, total an average of six month
Title
Target 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, total an average of six 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, total an average of six month
Title
Late toxicity evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme
Description
Evaluated every three months with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme
Time Frame
total an average of 2-year

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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Optimal Margin Evaluation of Online Adaptive Radiotherapy for Postoperative Treatment of Endometrial and Cervical Cancer

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