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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Online adaptive radiotherapy | Daily online adaptive radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| online adaptive radiotherapy | Radiation | Online adaptive radiotherapy compared to standard non-adaptive Image-Guided Radiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| All Early Common Terminology Criteria for Adverse Events (CTCAE) Treatment Related Toxicities. Grade 1-5 (5 being the highest) | percentage of patients with grade 2 or more early treatment-related toxicity | from mid-treatment to 3 months after end of treatment |
| All Late Common Terminology Criteria for Adverse Events (CTCAE) Treatment Related Toxicities |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with non-metastatic squamous cell carcinoma of the anus, referred for chemo-radiotherapy with curative intent.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eva Serup-Hansen, MD, PhD | Contact | +4538689084 | eva.serup-hansen@regionh.dk | |
| katrine S storm, MD | Contact | +4538686269 | katrine.smedegaard.storm@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Eva S Serup-Hansen, MD, PhD | Herlev og Gentofte Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology dept, Herlev and Gentofte Hospital | Recruiting | Herlev | 2730 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38528456 | Derived | 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. |
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| ID | Term |
|---|---|
| D001005 | Anus Neoplasms |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
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percentage of patients with grade 2 or more late treatment-related toxicity |
| From 3 months after end of treatment to 5 years follow-up |
| Patient Reported Outcomes (PRO) | 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 | from baseline to 5 years follow-up |
| European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Assessment | Collection ofEuropean Organisation for Research and Treatment of Cancer (EORTC) Quality of life questionnaire C30 | from baseline to 5 years follow-up |
| Progression Free Survival | Progression free survival (from time of inclusion to disease progression) | From time of inclusion to disease progression, assessed up to 5 years follow-up |
| Overall Survival | Overall survival | From time of inclusion to death from any cause, assessed up to 5 years follow-up |
| Disease Free Survival | Disease Free Survival | From time of inclusion to death from bladder cancer, assessed up to 5 years follow-up |
| Treatment Related Hospitalization | Hospitalization due to radiation therapy treatment related toxicity | From of start of radiation therapy through 5 year follow-up |
| D004067 |
| Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |