Combined Modality Therapy for Patients With With HIV and Stage I, Stage II, or Stage III Anal Cancer
Trial · NCT00324415
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Locoregional Failure Rate at 3 Years | 3 years following completion of therapy | Patients will be classified into two groups for purposes of primary endpoint analysis: failure or no failure at 3 years (in the primary analysis, patients lost to follow-up prior to 3 years will be considered failures). For the secondary endpoint of objective response, patients will be classified as responders |
| Secondary | Progression-free Survival | 1 year | Progression-free survival at 1 year is the percentage of patients who are alive and have not experienced progressive disease, defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one or more new lesions. |
| Secondary | Relapse-free Survival | 1 year | Percentage of participants who are alive and have not experienced progressive disease and have not relapsed |
| Secondary | Colostomy-free Survival at 1 Year | 1 year | Percentage of participants who are alive and have not had a colostomy |
| Secondary | Overall Survival | 1 year | Percentage of participants who are alive at one year |
| Secondary | Quality of Life EORTC Global Score at 1 Year | 1 year | EORTC QLQ-C30 Global Score at 1 year. The EORTC QLQ-C30 is a validated questionnaire that evaluates quality of life. The global score is an overall score for quality of life that ranges from 0 to 100. Higher scores indicate between quality of life |
| Secondary | Number of Delayed Toxicities | 90 days following treatment discontinuation | Delayed toxicities are defined as toxicities that occur over 90 days following treatment completion |
| Secondary | Changes in CD4 Counts During and for 1 Year After Completion of Study Treatment | 1 year following treatment discontinuation | Change in absolute CD4 counts from start of treatment to 1 year after completion of study treatment |
| Secondary | Incidence of Opportunistic Illnesses | 1 year following treatment discontinuation | Incidence of opportunistic illnesses, including the development of AIDS during and for 1 year after completion of study treatment |
| Secondary | Objective Response Rate (Complete and Partial) | 3 years following treatment discontinuation | Number of participants with complete and partial responses based on the RECIST criteria |
| Other | Count of Participants by Type of HPV at Baseline | baseline | Descriptive statistics will be used to describe the types of HPV found in baseline anal swabs and tissue biopsies. Proportion of cases with each type will be summarized |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT00324415/registered