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Clinical Trials/DRKS00020739
DRKS00020739
Completed
Phase 2

Radiochemotherapy +/- Durvalumab for locally-advanced Anal Carcinoma. A multicenter, randomized, phase II trial of the German Anal Cancer Study Group - RADIANCE

Goethe Universität; Universitätsklinikum Frankfurt Goethe-Universität0 sites180 target enrollmentJanuary 31, 2020
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ConditionsC21Malignant neoplasm of anus and anal canal

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
C21
Sponsor
Goethe Universität; Universitätsklinikum Frankfurt Goethe-Universität
Enrollment
180
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 31, 2020
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Goethe Universität; Universitätsklinikum Frankfurt Goethe-Universität

Eligibility Criteria

Inclusion Criteria

  • •Histologically\-confirmed ASCC (both genders) of the anal canal or the anal margin
  • •UICC\-Stage IIB\-IIIC including T2\>\=4cm Nany (IIB: T3N0M0; IIIA: T1\-2N1M0; IIIB: T4N0M0; IIIC: T3\-4N1M0; T2\>\=4cm Nany) according to proctoscopy, pelvic MRI, CT scan of thorax and abdomen, all within 30 days prior to recruitment
  • •Age \= 18 years, no upper age limit
  • •ECOG\-Performance score 0\-1
  • •History/physical examination within 30 days prior to recruitment
  • •Written informed consent and any locally\-required authorization (e.g. EU Data Privacy Directive in the EU) obtained from the patient prior to performing any protocol\-related procedures, including screening evaluations
  • •Life expectancy of \> 12 months
  • •Body weight \>30kg
  • •Hemoglobin \=9\.0 g/dl
  • •Leukocytes \>3\.5 x 10^9/l

Exclusion Criteria

  • •UICC\-Stage I\-IIA ASCC defined as cT1N0M0 or cT2 \<4cm N0M0 disease
  • •Second malignancy other than basalioma or cervical/genital/ neoplasia in situ
  • •History of another primary malignancy except for
  • •\- Malignancy treated with curative intent and with no known active disease \=5 years before the first dose of durvalumab and of low potential risk for recurrence
  • •\- Adequately treated non\-melanoma skin cancer or lentigo maligna without evidence of disease
  • •\- Adequately treated carcinoma in situ without evidence of disease
  • •Known DPD\-deficiency
  • •Participation in another clinical study with an investigational product during the last 12 months
  • •Concurrent enrolment in another clinical study, unless it is an observational (non\-interventional) clinical study or during the follow\-up period of an interventional study
  • •Any previous treatment with other immunotherapy, a PD1 or PD\-L1 inhibitor

Outcomes

Primary Outcomes

Not specified

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