Status:
UNKNOWN
Role of Antisecretory Factor in Curative Radiochemotherapy for Anal Carcinoma
Lead Sponsor:
Uppsala University Hospital
Collaborating Sponsors:
Lantmännen AB
Sjöbergstiftelsen
Conditions:
Anal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Curative radiochemotherapy (RCT) for anal carcinoma (AC) is associated with considerable acute and long-term toxicity. The acute toxicity derives from the combined effects of radiation and chemotherap...
Detailed Description
Curative RCT for AC is associated with considerable acute and long-term toxicity. The acute toxicity derives from the combined effects of radiation and chemotherapy and is dominated by localized skin...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- Histologically confirmed diagnosis of AC irrespective of tumour p16-status.
- Planned for curative RCT according to national care programme schedule B
- WHO performance status of 0 or 1.
- For patients planned for schedule C, they must be unsuitable for or not consenting to participation in the SWANCA trial.
- Able to understand study information and questionnaires and provide signed informed consent.
Exclusion
- Patients with stoma.
- Contraindications to the investigational product, e g known or suspected hypersensitivity to the investigational products or expected inability to their use in accordance with the protocol.
- Contraindications to curative RCT in accordance with AC national care programme.
- Lack of suitability for participation in the study, e g expected difficulties to follow the protocol procedures, as judged by the investigator.
- Prior exposure to Salovum or SPC-flakes.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT05351931
Start Date
June 1 2022
End Date
March 1 2024
Last Update
April 28 2022
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