PLAN-A Data- Bio- and Plan- Bank Collection for SCCA in Denmark

Aarhus University Hospital314 enrolled

Overview

The study is a prospective registration of treatment related-, toxicity-, Quality of life- and outcome data from patients treated in Denmark with radiotherapy for squamous cell carcinoma of the anus (SCCA), as a cooperation within the Danish Anal Cancer Group (DACG). Substudy one: A prospective biobank is collected with the purpose to identify predictive and prognostic markers for outcome. Substudy two: MRI scans are performed to investigate the rate of pelvic insufficience fractures at one year post chemoradiotherapy.

Study Type

OBSERVATIONAL

Enrollment

314

Conditions

Anal Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 * Squamous cell carcinoma of the anus, and indication for curatively intended radiotherapy * Written and oral consent Exclusion Criteria: * Contraindication to blood sampling or MRI scans (substudy 1 and 2) * Other malignant disease within 5 years except from basal cell carcinomas

Locations (3)

Aarhus University Hospital

Aarhus, Denmark

Herlev Hospital

Herlev, Denmark

Vejle Hospital

Vejle, Denmark

Outcomes

Primary Outcomes

Complete clinical response

Rate of complete response to primary treatment as defined by clinical and radiological evaluation

Time frame: 3 years

Secondary Outcomes

Early toxicity evaluation by CTCAE

The rate of treatment related adverse events (assessed by CTCAE v.4.0) related to bowel, skin, bladder and bone.

Time frame: 2 weeks after the last day of therapy

Late toxicity evaluation by CTCAE

The rate of treatment related adverse events (assessed by CTCAE v.4.0) related to bowel, skin, bladder and bone.

Time frame: 1 and 3 years post treatment

Quality of life assessed by the EORTC QoL questionaires

European Organisation for Research and Treatment of Cancer (EORTC) quality of life (QoL) questionnaire (QLQ) C30 (core). The EORTC QLQ-CR29 is a tumor-specific health related QoL questionnaire module for CRC (colorectal cancer) patients, which is designed to complement the EORTC QLQ-C30 questionnaire. Patients are asked to indicate their symptoms during the past week(s). Scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms on the symptom scales.

Time frame: 2 weeks, 1 and 3 years post therapy

Prognostic value of ctDNA

Measurement of circulating tumor DNA (in copies per ML)

Time frame: At time of treatment completion, an average of 30 days, 1 and 3 years post therapy

Incidence of pelvis fractures

Frequency of pelvic insufficience fractures at MRI scans

Time frame: 1 and 3 years post therapy

Data from ClinicalTrials.gov

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