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Online Adaptive Radiotherapy Cervical Cancer With Reduced Margin for Cervical Cancer

Primary Purpose

Uterine Cervical Neoplasm

Status
Recruiting
Phase
Phase 1
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, Online Adaptive Radiotherapy

Eligibility Criteria

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

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Online Adaptive Radiotherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Patient-reported acute toxicity
Patient-reported acute toxicity evaluated with European Organization for Research and Treatment of Cancer Quality of Life C30 (EORTC QLQ-C30) 3.0 questionnaire
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 irradiated doses of organs at risk
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
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 volume 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.
Response evaluation evaluated with RECIST 1.1
Evaluated with RECIST 1.1
Movement of the uterus during per radiotherapy fractions
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.
Movement of the cervix during per radiotherapy fractions
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.
Progression-free survival
Progression-free survival is defined as the time from randomization to disease progression or death from any cause, whichever is first.

Full Information

First Posted
April 26, 2023
Last Updated
May 19, 2023
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05880485
Brief Title
Online Adaptive Radiotherapy Cervical Cancer With Reduced Margin for Cervical Cancer
Official Title
A Prospective Study to Evaluate Online Adaptive Radiotherapy in Cervical Cancer With Reduced Margin
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Neoplasm
Keywords
Uterine Cervical Neoplasm, Online Adaptive 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
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Online Adaptive Radiotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
online adaptive radiotherapy
Intervention Description
PTV with 5-10 margins covers CTV
Primary Outcome Measure Information:
Title
Patient-reported acute toxicity
Description
Patient-reported acute toxicity evaluated with European Organization for Research and Treatment of Cancer Quality of Life C30 (EORTC QLQ-C30) 3.0 questionnaire
Time Frame
From the start of treatment to 3 months after treatment
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 irradiated doses of organs at risk
Description
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
Time Frame
Through study completion, an average of eight month
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 eight month
Title
Target volume 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 eight month
Title
Response evaluation evaluated with RECIST 1.1
Description
Evaluated with RECIST 1.1
Time Frame
One month after treatment
Title
Movement of the uterus during per radiotherapy fractions
Description
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.
Time Frame
Through study completion, an average of eight month
Title
Movement of the cervix during per radiotherapy fractions
Description
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.
Time Frame
Through study completion, an average of eight month
Title
Progression-free survival
Description
Progression-free survival is defined as the time from randomization to disease progression or death from any cause, whichever is first.
Time Frame
2-year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 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. Age ≥18 years and ≤ 75 years. Patients with newly histologically confirmed cervical cancer, including squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma, et al. No evidence of para-aortic metastatic lymph nodes (MLNs) and inguinal lymph nodes on CT, MRI or positron emission tomograph (PET)/CT. No contraindications to CT scanning. No evidence of distant metastasis (FIGO stage IVB). 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: With common iliac MLNs. Tumor extended to the lower third of the vagina. Tumor spread to mucosa of the bladder or rectum. Prior surgery (including pelvic or para-aortic lymph nodes resection, except for tumor biopsy), radiotherapy or chemotherapy to primary tumor or nodes. Prior malignancy. History of previous radiotherapy to the abdomen or pelvis. Pregnancy or lactation. Active inflammatory bowel disease, or history of severe stomach or duodenal ulcer. Active infection with fever. Patients with unacceptable risk that intracavitary brachytherapy can not be conducted. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fuquan Zhang, M.D.
Phone
+86 13311360431
Email
zhangfq@pumch.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Guangyu Wang, M.D.
Phone
+86 19862181605
Email
sdwanggy@sina.com
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guangyu Wang, M.D.
Phone
+86 19862181605
Email
sdwanggy@sina.com

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
background
PubMed Identifier
36356834
Citation
Yen A, Choi B, Inam E, Yeh A, Lin MH, Park C, Hrycushko B, Nwachukwu C, Albuquerque K. Spare the Bowel, Don't Spoil the Target: Optimal Margin Assessment for Online Cone Beam Adaptive Radiation Therapy (OnC-ART) of the Cervix. Pract Radiat Oncol. 2023 Mar-Apr;13(2):e176-e183. doi: 10.1016/j.prro.2022.10.009. Epub 2022 Nov 7.
Results Reference
result

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Online Adaptive Radiotherapy Cervical Cancer With Reduced Margin for Cervical Cancer

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