NCT05438836

Brief Summary

A single-arm, prospective, Phase II, single-center clinical trial that will investigate if daily online adaptive radiotherapy for anal cancer will significantly reduce early treatment-related GI toxicity compared with the historically reported rate for non-adaptive intensity modulated radiation therapy (IMRT).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Jan 2022Jan 2031

Study Start

First participant enrolled

January 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 30, 2022

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2031

Expected
Last Updated

September 25, 2023

Status Verified

September 1, 2023

Enrollment Period

4 years

First QC Date

June 27, 2022

Last Update Submit

September 21, 2023

Conditions

Anal CancerAnal CarcinomaAnal Squamous Cell Carcinoma

Keywords

adaptive radiotherapyAnal cancerOnline Adaptive radiotherapy (oART)

Outcome Measures

Primary Outcomes (1)

  • Early Rate of Common Terminology Criteria for Adverse Events (CTCAE) Gastrointestinal Toxicity grade 2 or more (scale from 0-5, 5 being the highest)

    percentage of patients with grade 2 or more early treatment-related Gastrointestinal-toxicity

    from mid-treatment to 3 months after end of treatment

Secondary Outcomes (8)

  • All Early Common Terminology Criteria for Adverse Events (CTCAE) Treatment Related Toxicities. Grade 1-5 (5 being the highest)

    from mid-treatment to 3 months after end of treatment

  • All Late Common Terminology Criteria for Adverse Events (CTCAE) Treatment Related Toxicities

    From 3 months after end of treatment to 5 years follow-up

  • Patient Reported Outcomes (PRO)

    from baseline to 5 years follow-up

  • European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Assessment

    from baseline to 5 years follow-up

  • Progression Free Survival

    From time of inclusion to disease progression, assessed up to 5 years follow-up

  • +3 more secondary outcomes

Study Arms (1)

Online adaptive radiotherapy

Daily online adaptive radiotherapy

Radiation: online adaptive radiotherapy

Interventions

online adaptive radiotherapyRADIATION

Online adaptive radiotherapy compared to standard non-adaptive Image-Guided Radiotherapy

Also known as: Varian Ethos Adaptive Radiation Therapy
Online adaptive radiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with non-metastatic squamous cell carcinoma of the anus, referred for chemo-radiotherapy with curative intent.

You may qualify if:

  • Biopsy-verified anal cancer
  • Eligible for curative intended radiotherapy
  • Written and oral consent

You may not qualify if:

  • Other malignant disease within the past 5 years (excluding basal cell carcinoma)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oncology dept, Herlev and Gentofte Hospital

Herlev, 2730, Denmark

RECRUITING

Related Publications (1)

  • Storm KS, Astrom LM, Sibolt P, Behrens CP, Persson GF, Serup-Hansen E. ROAR-A: re-optimization based Online Adaptive Radiotherapy of anal cancer, a prospective phase II trial protocol. BMC Cancer. 2024 Mar 25;24(1):374. doi: 10.1186/s12885-024-12111-1.

    PMID: 38528456DERIVED

MeSH Terms

Conditions

Anus Neoplasms

Condition Hierarchy (Ancestors)

Rectal NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal Diseases

Study Officials

  • Eva S Serup-Hansen, MD, PhD

    Herlev og Gentofte Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Serup-Hansen, MD, PhD

CONTACT

+4538689084eva.serup-hansen@regionh.dk

katrine S storm, MD

CONTACT

+4538686269katrine.smedegaard.storm@regionh.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical oncologist, MD, PhD

Study Record Dates

First Submitted

June 27, 2022

First Posted

June 30, 2022

Study Start

January 1, 2022

Primary Completion

January 1, 2026

Study Completion (Estimated)

January 1, 2031

Last Updated

September 25, 2023

Record last verified: 2023-09

Locations

DK(1)