Trial · NCT00003641
High-Dose Interferon Alfa in Treating Patients With Stage II or Stage III Melanoma
NCT00003641, Phase 3, Completed, ECOG-ACRIN Cancer Research Group; results first posted 2016-05-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. High-Dose Interferon Alfa in Treating Patients With Stage II or Stage III Melanoma. Trials, record NCT00003641. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00003641
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- High-Dose Interferon Alfa in Treating Patients With Stage II or Stage III Melanoma
- NCT number
- NCT00003641
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,150 participants, actual
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Conditions
- Melanoma (Skin)
- Interventions
- interferon alfa-2b, observation
- First posted
- 2003-01-27
- Last updated
- 2026-09-29
- Results first posted
- 2016-05-04
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 5-year Relapse-free Survival Rate | assessed every 3 months for 2 years, every 6 months for 3 years | Relapse-free survival (RFS) was defined as time from randomization to disease relapse or death from any cause, whichever occurred first. Patients without disease relapse were censored at last disease assessment date known of free of relapse. Kaplan-Meier method was used to estimate 5-year RFS rate in the intent-to-treat (ITT) patients. |
| Secondary | 5-year Overall Survival Rate | assessed every 3 months for 2 years, every 6 months for 3 years | Overall survival (OS) was defined as time from randomization to death from any cause. Patients still alive were censored at last known alive date. Kaplan-Meier method was used to estimate 5-year OS rate in the ITT patients. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 5-year Relapse-free Survival Rate | assessed every 3 months for 2 years, every 6 months for 3 years | all randomized patients | proportion of participants | NUMBER |
| SECONDARY | 5-year Overall Survival Rate | assessed every 3 months for 2 years, every 6 months for 3 years | all randomized patients | proportion of participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 5-year Relapse-free Survival Rate | Observation | 0.70 | 95% Confidence Interval 0.66 to 0.74 | proportion of participants | |
| 5-year Relapse-free Survival Rate | Interferon Alfa-2b | 0.70 | 95% Confidence Interval 0.66 to 0.74 | proportion of participants | |
| 5-year Overall Survival Rate | Observation | 0.83 | 95% Confidence Interval 0.79 to 0.86 | proportion of participants | |
| 5-year Overall Survival Rate | Interferon Alfa-2b | 0.83 | 95% Confidence Interval 0.80 to 0.86 | proportion of participants |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Observation | 569 | |
| Overall Study | STARTED | Interferon Alfa-2b | 581 | |
| Overall Study | Treated | Observation | 2 | |
| Overall Study | Treated | Interferon Alfa-2b | 569 | |
| Overall Study | Toxicity Assessed | Observation | 439 | |
| Overall Study | Toxicity Assessed | Interferon Alfa-2b | 568 | |
| Overall Study | COMPLETED | Observation | 0 | |
| Overall Study | COMPLETED | Interferon Alfa-2b | 407 | |
| Overall Study | NOT COMPLETED | Observation | 569 | |
| Overall Study | NOT COMPLETED | Interferon Alfa-2b | 174 |
Source ClinicalTrials.gov
Adverse events202
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Observation | 12 | 439 | |
| other | Anemia | Blood and lymphatic system disorders | Interferon Alfa-2b | 123 | 568 | |
| other | Leukocytes decreased | Investigations | Observation | 6 | 439 | |
| other | Leukocytes decreased | Investigations | Interferon Alfa-2b | 321 | 568 | |
| other | Neutrophils decreased | Investigations | Observation | 4 | 439 | |
| other | Neutrophils decreased | Investigations | Interferon Alfa-2b | 283 | 568 | |
| other | Platelets decreased | Investigations | Observation | 2 | 439 | |
| other | Platelets decreased | Investigations | Interferon Alfa-2b | 200 | 568 | |
| other | Fatigue | General disorders | Observation | 11 | 439 | |
| other | Fatigue | General disorders | Interferon Alfa-2b | 454 | 568 |
1 to 10 of 202Source ClinicalTrials.gov
See all 202 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Observation | ||
| Total, all-cause mortality | Interferon Alfa-2b | ||
| Total, other adverse events | Observation | 74 | 439 |
| Total, other adverse events | Interferon Alfa-2b | 558 | 568 |
| Total, serious adverse events | Observation | 20 | 439 |
| Total, serious adverse events | Interferon Alfa-2b | 325 | 568 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA023318 | ECOG Statistical Office | GRAY, ROBERT J | DANA-FARBER CANCER INST | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Observation vs Interferon Alfa-2b: serious adverse events |
Source Trial comparisons
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/NCT00003641
GET https://conductscience.org/api/trials/v1/NCT00003641/events?page=2