Anal Cancer, Anal Carcinoma, Anal Squamous Cell Carcinoma
Conditions
Keywords
adaptive radiotherapy, Anal cancer, Online Adaptive radiotherapy (oART)
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).
Interventions
RADIATIONonline adaptive radiotherapy
Online adaptive radiotherapy compared to standard non-adaptive Image-Guided Radiotherapy
Sponsors
Herlev Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Biopsy-verified anal cancer * Eligible for curative intended radiotherapy * Written and oral consent
Exclusion criteria
* Other malignant disease within the past 5 years (excluding basal cell carcinoma)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early Rate of Common Terminology Criteria for Adverse Events (CTCAE) Gastrointestinal Toxicity grade 2 or more (scale from 0-5, 5 being the highest) | from mid-treatment to 3 months after end of treatment | percentage of patients with grade 2 or more early treatment-related Gastrointestinal-toxicity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All Late Common Terminology Criteria for Adverse Events (CTCAE) Treatment Related Toxicities | From 3 months after end of treatment to 5 years follow-up | percentage of patients with grade 2 or more late treatment-related toxicity |
| Patient Reported Outcomes (PRO) | from baseline to 5 years follow-up | Collection of National Cancer Institute Patient Reported Outcome-Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE) questionnaire (scale from none to a lot) and comparison to Common Terminology Criteria for Adverse Events (CTCAE) and dosimetry data |
| European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Assessment | from baseline to 5 years follow-up | Collection ofEuropean Organisation for Research and Treatment of Cancer (EORTC) Quality of life questionnaire C30 |
| 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 | percentage of patients with grade 2 or more early treatment-related toxicity |
| Overall Survival | From time of inclusion to death from any cause, assessed up to 5 years follow-up | Overall survival |
| Disease Free Survival | From time of inclusion to death from bladder cancer, assessed up to 5 years follow-up | Disease Free Survival |
| Treatment Related Hospitalization | From of start of radiation therapy through 5 year follow-up | Hospitalization due to radiation therapy treatment related toxicity |
| Progression Free Survival | From time of inclusion to disease progression, assessed up to 5 years follow-up | Progression free survival (from time of inclusion to disease progression) |
Countries
Denmark
Contacts
Primary ContactEva Serup-Hansen, MD, PhD
Backup Contactkatrine S storm, MD
Outcome results
None listed