MR-Adaptive Radiation Therapy for Anal Cancer With EScalated-Treatment in a Risk-Optimized Approach

PHASE2RECRUITING

The proposed study is a phase II, single arm, open-label trial of MR-guided radiation therapy (RT) with risk stratified RT dose selection in patients with anal cancer. Based on previous data, a risk adaptive treatment approached is proposed in 4 groups: Low risk, standard risk, intermediate risk, and high risk. Human papillomavirus (HPV) DNA will be analyzed to identify novel biomarkers that predict chemoradiotherapy (CRT) response and toxicity.

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Study details:

After being informed about the study and potential risks, all patients giving written informed consent will undergo a risk-stratified dose of treatment (radiation dose and chemotherapy number of cycles) based on predefined clinical and biological biomarkers for anal squamous cell carcinoma (SCC). Radiotherapy will be delivered on the MR-Linac for image-guided-radiation therapy (IGRT). Patients will be followed for up to 5 years after radiotherapy and be required to complete questionnaires and clinic visits.

Patients have the option to complete blood and tissue samples during the study.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • Patients with pathologically proven diagnosis of anal SCC. This may include tumors of non-keratinizing histology such as basoloid or cloacogenic histology. Individuals with squamous cell carcinoma of the anal margin are eligible.
  • Clinical stage T1-4 N0-1 M0 (the Union for International Cancer Control (UICC) / the American Joint Committee on Cancer (AJCC) 8th Ed)
  • Patients must be eligible for definitive RT or CRT
  • Must be ≥ 18 years of age
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Exclusion criteria

  • Previous chemotherapy, RT or curative-intent surgical treatment (i.e. APR) for anal cancer.
  • Any previous RT to the abdomino-pelvic region that would result in overlap of RT volume for the current study.
  • Individuals with a history of a different malignancy except if they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2023-09-29

    Primary completion: 2028-09-01

    Study completion finish: 2028-09-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE2

    trial

    Trial ID

    NCT06050707

    Intervention or treatment

    RADIATION: Radiotherapy - Low risk group

    RADIATION: Radiotherapy - Standard risk group

    RADIATION: Radiotherapy - Intermediate risk group

    RADIATION: Radiotherapy - High risk group

    Conditions

    • Anal Squamous Cell Carcinoma
    Image related to Anal Squamous Cell Carcinoma
    • Condition: Anal Squamous Cell Carcinoma

    • RADIATION: Radiotherapy - Low risk group and other drugs

    • Heidelberg, Victoria, Australia

    • Sponsor: University Health Network, Toronto

    Find a site

    Closest Location:

    Austin Health

    Research sites nearby

    Select from list below to view details:

    • Austin Health

      Heidelberg, Victoria, Australia

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    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?

    Participant Group/ArmIntervention/Treatment

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Change in locoregional failure (LRF) at Year 2Any local or regional failure from the date of registration to the date of any of the local or regional failure.2 years

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Presence of distant metastasis (DM)Clear clinical/radiographic evidence of distant metastases in the lung, bone, brain, liver or other distant sites.5 years
    Colostomy rateThe presence of a colostomy until colostomy removal.5 years
    Disease free survival (DFS)The time from the date of registration to the date of first record of any of the following events including local, regional, distant failure, or death due to any cause.5 years
    Overall survival (OS)The time from the date of registration to the date of death for any cause.5 years
    Physician-reported toxicitiesUsing the National Cancer Institute (NCI) Common Terminology Criteria of Adverse Events (CTCAE) V.5.5 years
    Patient Reported OutcomesUsing the Common Terminology Criteria of Adverse Events5 years
    Quality of life (QOL)Based on the completion of the European Organisation For Research And Treatment Of Cancer (EORTC-C30) questionnaire. The EORTC-C30 questionnaire is a 30 item instrument meant to assess some of the different aspects that define the quality of life of cancer patients.5 years
    Quality of life (QOL)Based on the completion of the European Organisation For Research And Treatment Of Cancer (EORTC-AN27) questionnaire. EORTC QLQ-ANL27 includes four quality of life domains: pain, bowel, sexual and stoma care problems and five single item (frequent urination, keeping clean, proximity to toilet, lower limb oedema, planning activities)5 years

    Frequently Asked Questions

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    References

    Clinical Trials Gov: MR-Adaptive Radiation Therapy for Anal Cancer With EScalated-Treatment in a Risk-Optimized Approach

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