Study on Adaptive Radiotherapy and Multimodal Information of Cervical Cancer Assisted by Artificial Intelligence (SOARAMIOCC)

March 25, 2020 updated by: The University of Hong Kong-Shenzhen Hospital

The standard treatment for non-operative cervical cancer is concurrent external radiation therapy and chemotherapy followed by brachytherapy. During the period of radiotherapy, organ movement and tumor shrinkage may lead to insufficient or excessive radiation dose for the tumor and organs at risk. Adaptive radiotherapy can use images information acquired during treatment as feedback to reduce errors.

Total 122 cases of cervical cancer with stage IB2-IVA will be randomly enrolled. Concurrent external volumetric rotational intensity modulated radiotherapy and chemotherapy followed by image-guided adaptive brachytherapy is the treatment strategies of control group patients.

Concurrent adaptive external volumetric rotational intensity modulated radiotherapy and chemotherapy followed by image-guided adaptive brachytherapy is the treatment strategies of experimental group patients. CT repositioning will be performed after 15fractions of external radiotherapy, then new target volume will be contoured and new radiotherapy plan will be formulated with the assistance of artificial intelligence program. New radiotherapy plan will be performed from the 17th fraction external radiotherapy. Information on side effects, survival, dosimetry, imaging, clinical features, and cost-effectiveness will be collected. The statistical analysis is as follows, First is the difference in grade 3 side effects between the two groups. Second is 2-year PFS and OS differences between the two groups. Third is relationship between dosimetric differences and prognosis. Fourth one is to analyze the prognostic and predictive factors of adaptive radiotherapy from the patient's clinical characteristics, Positron emission tomography-computed tomography(PET/CT), Magnetic Resonance Imaging(MRI) and other multimodal information. Fifth is cost-benefit analysis of Artificial Intelligence(AI).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  1. Introduction and background The standard treatment for non-operative cervical cancer is concurrent external radiation therapy and chemotherapy followed by brachytherapy. During the period of radiotherapy, organ movement and tumor shrinkage may lead to insufficient or excessive radiation dose for the tumor and organs at risk. Adaptive radiotherapy can use images information acquired during treatment as feedback to reduce errors.
  2. Hypothesis and purpose Main endpoint: adaptive radiotherapy can reduce level 3 side effects or not. Secondary endpoint: 1. The differences of 2-year progression-free survival and overall survival between two groups. 2. To analyze Physical dosimetry differences between two groups, and the correlation between physical dosimetry differences and prognosis also will be evaluated. 3. To analyze the prediction and prognostic factors of adaptive radiotherapy for cervical cancer, and to provide supporting data for the subsequent optimization of cervical cancer treatment. 4. To evaluate the effectiveness of AI and conduct cost-benefit analysis.

  3. Trial methodology and design Total 122 cases of IB2-IVA cervical cancer will be randomly enrolled. Concurrent external volumetric rotational intensity modulated radiotherapy and chemotherapy followed by image-guided adaptive brachytherapy is the treatment strategies of control group patients.

    Concurrent adaptive external volumetric rotational intensity modulated radiotherapy and chemotherapy followed by image-guided adaptive brachytherapy is the treatment strategies of experimental group patients. CT repositioning will be performed after 15fractions of external radiotherapy, then new target volume will be contoured and new radiotherapy plan will be formulated with the assistance of artificial intelligence program. New radiotherapy plan will be performed from the 17th fraction external radiotherapy.

    Meanwhile, concurrent chemotherapy regimen is cisplatin 40mg/m2/week (the maximum weekly dose should less than or equal to 70mg and no more than 6cycles). Information on side effects, survival, dosimetry, imaging, clinical features, and cost-effectiveness will be collected. The statistical analysis is as follows, First is the difference in grade 3 side effects between the two groups. Second is 2-year PFS and OS differences between the two groups. Third is relationship between dosimetric differences and prognosis. Fourth one is to analyze the prognostic and predictive factors of adaptive radiotherapy from the patient's clinical characteristics, PET/CT, MRI and other multimodal information. Fifth is cost-benefit analysis of AI.

  4. Anticipated result and potential impact Adaptive radiotherapy can reduce side effects and obtain prognosis and prognostic factors of adaptive radiotherapy.

Study Type

Interventional

Enrollment (Anticipated)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518053
        • Recruiting
        • HongKong University Shenzhen Hospital
        • Contact:

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. pathologically confirmed cervical squamous cell carcinoma or adenocarcinoma without treatment before;
  2. Age: ≥18 years old;
  3. The International Federation of Gynecology and Obstetrics(FIGO) stage: IB2 to IVA, or IVB with only para-aortic lymph node metastasis, refused or could not be treated by surgery;
  4. Eastern Cooperative Oncology Group(ECOG)score ≤2;
  5. good bone marrow, hematopoietic and liver and kidney function: absolute neutrophil count (ANC) ≥ 1.5 ☓ 109 / L, the platelet count ≥100 ☓ 109 / L, or hemoglobin > 90 g/L, serum bilirubin < 1.5 ☓ upper limit of normal reference value(ULN), aspartate aminotransferase(AST) and alanine aminotransferase(ALT)< 2.5 ☓ ULN, serum creatinine clearance ≥ 50 ml/min.
  6. provide informed consent.

Exclusion Criteria:

  1. women in pregnancy or nursing;
  2. contraindications to chemoradiotherapy;
  3. subjects participating in other clinical trials or participating in other clinical trials within 30 days;

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adaptive radiotherapy group
Concurrent adaptive external volumetric rotational intensity modulated radiotherapy and chemotherapy followed by image-guided adaptive brachytherapy is the treatment strategies of adaptive radiotherapy group patients. CT repositioning will be performed after 15fractions of external radiotherapy, then new target volume will be contoured and new radiotherapy plan will be formulated with the assistance of artificial intelligence program. New radiotherapy plan will be performed from the 17th fraction external radiotherapy.
Radiation: Adaptive radiotherapy
CT repositioning will be performed after 15fractions of external radiotherapy, then new target volume will be contoured and new radiotherapy plan will be formulated with the assistance of artificial intelligence program. New radiotherapy plan will be performed from the 17th fraction external radiotherapy.
Active Comparator: Control group
Concurrent external volumetric rotational intensity modulated radiotherapy and chemotherapy followed by image-guided adaptive brachytherapy is the treatment strategies of control group patients.
Radiation: no adaptive radiotherapy
Concurrent external volumetric rotational intensity modulated radiotherapy and chemotherapy followed by image-guided adaptive brachytherapy is the treatment strategies of control group patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the difference in grade 3 side effects between the two groups
Time Frame: The acute radiotherapy reaction occur from the first day to 90 days after the end of radiotherapy, and the late radiotherapy reaction occur 90 days after radiotherapy.
Hematologic toxicity, bladder and rectal radiotherapy toxicity were recorded according to the evaluation criteria of common adverse events (CTCAE version 4.03).
The acute radiotherapy reaction occur from the first day to 90 days after the end of radiotherapy, and the late radiotherapy reaction occur 90 days after radiotherapy.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year PFS differences between the two groups
Time Frame: 2-year PFS
Follow-up every 3 months within 2 years after the end of radiotherapy, and every 6 months after 2 years. 2-year progression-free survival (PFS) will be calculated.
2-year PFS
2-year OS differences between the two groups
Time Frame: 2-year OS
Follow-up every 3 months within 2 years after the end of radiotherapy, and every 6 months after 2 years. 2-year overall survival (OS) will be calculated.
2-year OS
the correlation between physical dosimetry differences and prognosis
Time Frame: correlation between physical dosimetry differences and 2year PFS
To analyze Physical dosimetry differences between two groups, and the correlation between physical dosimetry differences and prognosis also will be evaluated.
correlation between physical dosimetry differences and 2year PFS
the predictive factors for the response rate of concurrent chemoradiotherapy for cervical cancer
Time Frame: 3 months after radiotherapy
To investigate the predictive factors for the response rate of concurrent chemoradiotherapy for cervical cancer. The investigating multimodal factors include patients'demographic characteristics, ECOG score, disease staging, human papilloma virus(HPV) status, tumor standard uptake value (SUV) of PET/CT and tumor apparent diffusion coefficient (ADC) value of MRI, squamous cell carcinoma antigen, lymphocyte and hemoglobin. Response rate is assessed at 3 months after completion of radiotherapy by MRI according to RECIST 1.1 criteria.
3 months after radiotherapy
the prognostic factors for the 2-year overall survival rate of patients with cervical cancer after concurrent chemoradiotherapy
Time Frame: 2 years after radiotherapy
To investigate the prognostic factors for the 2-year overall survival rate of patients with cervical cancer after concurrent chemoradiotherapy. The investigating multimodal factors include patients'demographic characteristics, ECOG score, disease staging, human papilloma virus(HPV) status, tumor standard uptake value (SUV) of PET/CT and tumor apparent diffusion coefficient(ADC) value of MRI, squamous cell carcinoma antigen, lymphocyte and hemoglobin. Overall survival is calculated from the date of diagnosis of cervical cancer to the date of death from any cause.
2 years after radiotherapy
the time difference between labor and an artificial intelligence to design radiotherapy plans
Time Frame: 2years
Compare the efficiency AI and labor.
2years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong-Shenzhen Hospital

Investigators

  • Principal Investigator: Zhi-Yuan Xu, master, HongKong University Shenzhen 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

Helpful Links

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)

December 18, 2019

Primary Completion (Anticipated)

May 30, 2022

Study Completion (Anticipated)

May 30, 2022

Study Registration Dates

First Submitted

July 1, 2019

First Submitted That Met QC Criteria

July 15, 2019

First Posted (Actual)

July 16, 2019

Study Record Updates

Last Update Posted (Actual)

March 27, 2020

Last Update Submitted That Met QC Criteria

March 25, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hkuszh2019119

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The results will be published as papers, but the original data will not be Shared

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.

Clinical Trials on Cervical Cancer

Clinical Trials on Adaptive radiotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe