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Clinical Trials/EUCTR2018-003005-25-DE
EUCTR2018-003005-25-DE
Active, not recruiting
Phase 1

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

niversity Hospital Frankfurt, Goethe University0 sites178 target enrollmentSeptember 3, 2019
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Conditionsanal cancer (UICC-Stage IIB-IIIC, incl. T2>4cm Nany )MedDRA version: 21.1Level: PTClassification code 10002136Term: Anal cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10002137Term: Anal cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsIMFINZI

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
anal cancer (UICC-Stage IIB-IIIC, incl. T2>4cm Nany )
Sponsor
niversity Hospital Frankfurt, Goethe University
Enrollment
178
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 3, 2019
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversity Hospital Frankfurt, Goethe University

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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