Anal Cancer Radiotherapy Study

NCT ID: NCT01937780

Last Updated: 2025-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-04

Study Completion Date

2025-12-31

Brief Summary

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This is a prospective study of patients receiving radiotherapy or chemoradiotherapy for anal cancer. Treatment effect in terms of survival and local recurrence will be analyzed. The utility of PET-CT and MRI for radiotherapy and for prediction of treatment effect will be investigated. Molecular and genetic markers in tumor and blood will be analyzed for prognostic and predictive effects. Patient-reported outcomes, such as faecal incontinence, sexual dysfunction and quality of life will be assessed. A structured intervention program for management of late effects will be evaluated. Symptom relief of palliative radiotherapy will be investigated. The main purpose of the study is to increase the knowledge of anal cancer treatment, improve treatment results, and improve anal cancer survivor care.

Detailed Description

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Conditions

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Anal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Histologically verified anal squamous cell carcinoma
* Radiotherapy or chemoradiotherapy planned
* ECOG performance status 0-2
* \>= 18 years of age
* Signed informed consent and expected cooperation of the patients for treatment and follow up

Exclusion Criteria

\- Cognitive or physical condition resulting in inability to sign informed consent or cooperation during treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Marianne Grønlie Guren

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marianne G Guren, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2012/2274

Identifier Type: -

Identifier Source: org_study_id

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