Trial · NCT04230759
Radiochemotherapy +/- Durvalumab for Locally-advanced Anal Carcinoma. A Multicenter, Randomized, Phase II Trial of the German Anal Cancer Study Group
NCT04230759, Phase 2, Active not recruiting, Goethe University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Radiochemotherapy +/- Durvalumab for Locally-advanced Anal Carcinoma. A Multicenter, Randomized, Phase II Trial of the German Anal Cancer Study Group. Trials, record NCT04230759. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04230759
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Radiochemotherapy +/- Durvalumab for Locally-advanced Anal Carcinoma. A Multicenter, Randomized, Phase II Trial of the German Anal Cancer Study Group
- NCT number
- NCT04230759
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 180 participants, actual
- Lead sponsor
- Goethe University
- Conditions
- Anal Cancer, Anal Carcinoma, Anal Cancer Stage III, Anal Cancer Stage II
- Interventions
- Chemotherapy, Radiation, Durvalumab
- First posted
- 2020-01-18
- Last updated
- 2026-08-14
- Other registries' IDs
- eudract:2018-003005-25
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease-free survival (DFS) | 3 years | DFS is defined as the time between randomization and the first of the following events: (a) non-complete clinical response at restaging MRI and proctoscopy, including biopsies of suspicious findings, 26 weeks after initiation of radiochemotherapy, (b) locoregional recurrence after initial complete clinical response (cCR), (c) distant metastases, (d) second primary cancer, or (e) death from any cause, whichever occurs first. Patients without any of these events are censored at the time point of last observation. |
| Secondary | Major adverse events | 3 Years | Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 |
| Secondary | cCR | 26 weeks | Complete clinical response rate assessed 26 weeks after initiation of radiochemotherapy |
| Secondary | Overall survival | 3 Years | Overall survival defined as the time between randomization and death from any cause |
| Secondary | Colostomy-free survival | 3 Years | Colostomy-free survival defined as time between randomization and a definitive colostomy for progression, relapse, or complication |
| Secondary | Cumulative incidence of locoregional recurrence | 3 Years | Cumulative incidence of locoregional recurrence defined as the incidence of locoregional recurrence form the time of randomization |
| Secondary | Cumulative incidence of distant recurrence | 3 Years | Cumulative incidence of distant recurrence defined as the incidence of distant recurrence form the time of randomization |
| Secondary | Quality of life questionnaires | 3 Years | Quality of life questionnaire QLQ-C30 |
| Secondary | Quality of life questionnaires | 3 Years | Quality of life questionnaire QLQ-ANL27 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04230759
GET https://conductscience.org/api/trials/v1/NCT04230759/registered