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Online Adaptive Radiation Therapy for Rectal Cancer

Primary Purpose

Rectal Cancer

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Online adaptive radiation therapy
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring rectal cancer, adaptive radiation therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ≥18 years old; Diagnose with rectal cancer; T3-T4 or N+, and no distant metastasis Neoadjuvant chemoradiotherapy intended; Surgery is expected after neoadjuvant therapy; ECOG score 0-2, expected to lie in the treatment bed for at least half an hour; Exclusion Criteria: With contraindications to rectal MRI; Received surgery, radiotherapy or chemotherapy for rectal cancer; History of pelvic radiotherapy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Online adaptive radiation therapy

    Arm Description

    Patients receive adaptive radiotherapy therapy and concurrent chemotherapy.

    Outcomes

    Primary Outcome Measures

    Acute toxicities(CTCA
    evaluated with Common Terminology Criteria for Adverse Events (CTCAE) 5.0
    Response rate after surgery
    Clinical and pathological complete response and partial response rate after chemoradiotherapy

    Secondary Outcome Measures

    Chronic toxicity
    evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme
    Dose coverage of target volume (assessed by planing target volume V100%)
    Planing target volume V100%, defined as the planing target volume receiving at least 100% of the prescribed dose (V100%), is used to evaluate the dose coverage of target volume.
    Margins for clinical target volume(CTV) and gross tumor volume (GTV)
    Margins needed in online ART for CTV to planning clinical target volume (PCTV) and GTV to planning gross tumor volume (PGTV) to cover inter/intra-fraction motion

    Full Information

    First Posted
    May 25, 2023
    Last Updated
    July 30, 2023
    Sponsor
    Peking Union Medical College Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05911789
    Brief Title
    Online Adaptive Radiation Therapy for Rectal Cancer
    Official Title
    A Prospective Study to Evaluate Online Adaptive Radiotherapy in Rectal Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 5, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2024 (Anticipated)
    Study Completion Date
    June 1, 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
    In the present study, the investigators will evaluate the efficacy, toxicities, and of online adaptive radiation therapy (ART) for patients with rectal cancer treated with neoadjuvant chemoradiotherapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rectal Cancer
    Keywords
    rectal cancer, adaptive radiation therapy

    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
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Online adaptive radiation therapy
    Arm Type
    Experimental
    Arm Description
    Patients receive adaptive radiotherapy therapy and concurrent chemotherapy.
    Intervention Type
    Radiation
    Intervention Name(s)
    Online adaptive radiation therapy
    Other Intervention Name(s)
    ART
    Intervention Description
    A dose of 45Gy will be delivered to planning target volume (PTV)
    Primary Outcome Measure Information:
    Title
    Acute toxicities(CTCA
    Description
    evaluated with Common Terminology Criteria for Adverse Events (CTCAE) 5.0
    Time Frame
    3 months for the start of treatment
    Title
    Response rate after surgery
    Description
    Clinical and pathological complete response and partial response rate after chemoradiotherapy
    Time Frame
    3 monsh after treatment
    Secondary Outcome Measure Information:
    Title
    Chronic toxicity
    Description
    evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme
    Time Frame
    2 years after treatment
    Title
    Dose coverage of target volume (assessed by planing target volume V100%)
    Description
    Planing target volume V100%, defined as the planing target 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
    Margins for clinical target volume(CTV) and gross tumor volume (GTV)
    Description
    Margins needed in online ART for CTV to planning clinical target volume (PCTV) and GTV to planning gross tumor volume (PGTV) to cover inter/intra-fraction motion
    Time Frame
    Through study completion, an average of five month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ≥18 years old; Diagnose with rectal cancer; T3-T4 or N+, and no distant metastasis Neoadjuvant chemoradiotherapy intended; Surgery is expected after neoadjuvant therapy; ECOG score 0-2, expected to lie in the treatment bed for at least half an hour; Exclusion Criteria: With contraindications to rectal MRI; Received surgery, radiotherapy or chemotherapy for rectal cancer; History of pelvic radiotherapy.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Online Adaptive Radiation Therapy for Rectal Cancer

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