Back to resultsModerately Hypofractionated Adaptive Radiotherapy for Cervical Cancer
Primary Purpose
Cervical Neoplasm, Adaptive Radiotherapy, Radiotherapy; Adverse Effect
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Moderately hypofractionated adaptive radiotherapy (ART)+ High-dose rate (HDR) Brachytherapy
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Neoplasm focused on measuring moderately hypofractionated radiotherapy, adaptive radiotherapy, cervical cancer.
Eligibility Criteria
Inclusion Criteria: Age 18 years to 70 years FIGO Stage IB1, IB2, IB3, IIA or IIB cervical cancers FIGO stage IIIC1 cervical cancers are candidates but must meet all the following criteria:largest node is less than 1.5 cm,less than 3 pathological nodes,No nodes located in the common iliac chain Histology: squamous Candidate for definitive chemoradiotherapy to be delivered with weekly cisplatin Brachytherapy candidate Functional State Eastern Cooperative Oncology Group (ECOG)0-2 Exclusion Criteria: Patients who had chemotherapeutic, surgical and/or radiotherapy treatment FIGO stage IIIA, IIIB, IIIC2, IVA or IVB FIGO stage IIIC1 with node greater than 1.5 cm, common iliac node or greater than 2 pathological nodes Previous pelvic or abdominal radiotherapy Patient unable to undergo MR scan ECOG performance status greater than 2 Not a cisplatin candidate Other factors that contraindicate experimental therapy
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Moderately Hypofractionated Adaptive Radiotherapy
Arm Description
Outcomes
Primary Outcome Measures
Acute toxicity
This outcome is assessed by physicians during each follow-up appointment, and scored according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 . Clinically relevant toxicities of gastrointestinal, genitourinary, vaginal and non-specific general symptoms (i.e. fatigue, malaise and pain) will be collected. Hematological disorders will also be collected through weekly blood work checks. Acute toxicities will be collected at baseline, and then weekly during radiotherapy/chemoradiotherapy and at 3 months after completion of radiation.
Secondary Outcome Measures
Late toxicity
Late toxicities will be collected from 3 months after completion of radiation onwards until the end of follow-up.
Response evaluation evaluated with RECIST 1.1
Evaluated with RECIST 1.1
Disease-free survival
Disease-free survival was defined as the period from the diagnosis of cervical cancer to events that included death or disease progression at local, regional, or distant sites or until the date of the last follow-up.
Overall survival
Overall survival was defined as the period from the diagnosis of cervical cancer to the date of death or last follow-up.
Quality of life (QoL)
QoL will be measured by the Expanded Prostate Cancer Index Composite (EPIC) questionnaire. The EPIC questionnaire contains 32 questions measuring patient function. Each question has a response option ranging from 0 or 1 (best) to 3, 4, or 5 (worst). The responses then correlate to a scoring scale of 0 to 100, where 0 is the best and 100 is the worst. The scores can then be added to come up with an overall quality of life score.
Quality of life (QoL)
QoL will evaluated by the EORTC QLQ-C-30 questionnaire.QLQ-C30 questionnaire is used for all cancers and has several symptom scales, five functional scales (physical, emotional, social, role, cognitive) and a global health status scale. Response options are a four-point Likert scale from "not at all" to "very much" or a seven-point Likert scale from "very poor" to "excellent."
Full Information
NCT ID
NCT05994300
First Posted
August 5, 2023
Last Updated
August 15, 2023
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05994300
Brief Title
Moderately Hypofractionated Adaptive Radiotherapy for Cervical Cancer
Official Title
Clinical Research of Moderately Hypofractionated Radiotherapy for Cervical Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2023 (Anticipated)
Primary Completion Date
September 15, 2025 (Anticipated)
Study Completion Date
December 31, 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
External radiation given in 25 fractions or so together with weekly chemotherapy and followed by 5 or 6 fractions of brachytherapy is the standard of care for patients with locally advanced cervical cancer. We hope to develop external moderately hypofractionated radiotherapy of cervical cancer based on adaptive radiotherapy.The objective of this study is to evaluate the efficacy and treatment-related toxicity of moderately hypofractionated adaptive radiotherapy in the treatment of cervical cancer.
Detailed Description
This is an investigator-initiated efficacious, single-center, open-label clinical trial study. This study hypothesizes that the use of external moderately hypofractionated radiotherapy of cervical cancer based on adaptive radiotherapy. A dose of 43.35Gy in 17 fractions is delivered to clinical target volume (CTV). 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
Cervical Neoplasm, Adaptive Radiotherapy, Radiotherapy; Adverse Effect
Keywords
moderately hypofractionated radiotherapy, adaptive radiotherapy, cervical cancer.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Moderately Hypofractionated Adaptive Radiotherapy
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Moderately hypofractionated adaptive radiotherapy (ART)+ High-dose rate (HDR) Brachytherapy
Intervention Description
Experimental: 43.35Gy/17F external beam radiotherapy (EBRT) with adaptive radiotherapy (ART) + HDR-Brachytherapy
Drug: Concurrent Chemotherapy
Weekly cisplatin 40 mg/m2
Primary Outcome Measure Information:
Title
Acute toxicity
Description
This outcome is assessed by physicians during each follow-up appointment, and scored according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 . Clinically relevant toxicities of gastrointestinal, genitourinary, vaginal and non-specific general symptoms (i.e. fatigue, malaise and pain) will be collected. Hematological disorders will also be collected through weekly blood work checks. Acute toxicities will be collected at baseline, and then weekly during radiotherapy/chemoradiotherapy and at 3 months after completion of radiation.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Late toxicity
Description
Late toxicities will be collected from 3 months after completion of radiation onwards until the end of follow-up.
Time Frame
3 years
Title
Response evaluation evaluated with RECIST 1.1
Description
Evaluated with RECIST 1.1
Time Frame
One month after treatment
Title
Disease-free survival
Description
Disease-free survival was defined as the period from the diagnosis of cervical cancer to events that included death or disease progression at local, regional, or distant sites or until the date of the last follow-up.
Time Frame
3 years
Title
Overall survival
Description
Overall survival was defined as the period from the diagnosis of cervical cancer to the date of death or last follow-up.
Time Frame
3 years
Title
Quality of life (QoL)
Description
QoL will be measured by the Expanded Prostate Cancer Index Composite (EPIC) questionnaire. The EPIC questionnaire contains 32 questions measuring patient function. Each question has a response option ranging from 0 or 1 (best) to 3, 4, or 5 (worst). The responses then correlate to a scoring scale of 0 to 100, where 0 is the best and 100 is the worst. The scores can then be added to come up with an overall quality of life score.
Time Frame
3 years
Title
Quality of life (QoL)
Description
QoL will evaluated by the EORTC QLQ-C-30 questionnaire.QLQ-C30 questionnaire is used for all cancers and has several symptom scales, five functional scales (physical, emotional, social, role, cognitive) and a global health status scale. Response options are a four-point Likert scale from "not at all" to "very much" or a seven-point Likert scale from "very poor" to "excellent."
Time Frame
3 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18 years to 70 years
FIGO Stage IB1, IB2, IB3, IIA or IIB cervical cancers
FIGO stage IIIC1 cervical cancers are candidates but must meet all the following criteria:largest node is less than 1.5 cm,less than 3 pathological nodes,No nodes located in the common iliac chain
Histology: squamous
Candidate for definitive chemoradiotherapy to be delivered with weekly cisplatin
Brachytherapy candidate
Functional State Eastern Cooperative Oncology Group (ECOG)0-2
Exclusion Criteria:
Patients who had chemotherapeutic, surgical and/or radiotherapy treatment
FIGO stage IIIA, IIIB, IIIC2, IVA or IVB
FIGO stage IIIC1 with node greater than 1.5 cm, common iliac node or greater than 2 pathological nodes
Previous pelvic or abdominal radiotherapy
Patient unable to undergo MR scan
ECOG performance status greater than 2
Not a cisplatin candidate
Other factors that contraindicate experimental therapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fuquan Zhang, MD
Phone
86-10-6915-5485
Email
Zhangfq@pumch.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zheng Zeng, MD
Phone
86-10-6915-5487
Email
zengzheng1206@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fuquan Zhang, MD
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
100010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fuquan Zhang, prof
Phone
86-10-69155485
Email
Zhangfq@pumch.cn
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
To protect the privacy of the patients
Learn more about this trial
Moderately Hypofractionated Adaptive Radiotherapy for Cervical Cancer
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