Trial · NCT03503864
Phase II Study of Combined Chemotherapy With Arsenic Trioxide in Stage 4/M Neuroblastoma
NCT03503864, Phase 2, Active not recruiting, Yang Li; results first posted 2025-05-21
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Phase II Study of Combined Chemotherapy With Arsenic Trioxide in Stage 4/M Neuroblastoma. Trials, record NCT03503864. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03503864
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study of Combined Chemotherapy With Arsenic Trioxide in Stage 4/M Neuroblastoma
- NCT number
- NCT03503864
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 80 participants, actual
- Lead sponsor
- Yang Li
- Conditions
- Neuroblastoma
- Interventions
- Arsenic Trioxide
- First posted
- 2018-04-20
- Last updated
- 2025-05-21
- Results first posted
- 2025-05-21
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate | Four weeks after ATO-combined induction chemotherapy | The percentage of patients who had complete remission（CR）or partial remission（PR）after induction chemotherapy combined ATO. Per Response Evaluation Criteria In Solid Tumors Criteria (WHO criteria) for target lesions and assessed by MRI or CT: CR: All lesions completely disappear, maintained for at least 4 weeks. PR: Estimated tumor size reduction by more than 50%, maintained for at least 4 weeks. |
| Secondary | Overall Survival Rate | 3 years. | The proportion of patients who are alive from the date of randomization to 3 years, regardless of the cause of death. |
| Secondary | Progression Free Survival Rate | 3 years. | The proportion of patients who have not experienced progression or death from any cause, whichever occurs first, within a maximum of 3 years from the date of enrollment. Treatment response was evaluated according to the WHO criteria for the efficacy of solid tumours, which was classified as complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD). PD was characterized as more than 25% increase in one or more lesions or appearance of new lesions. |
| Secondary | Number of Participants With Adverse Events | From date of ATO-combined chemotherapy until the date of first documented adverse event, and follow up for 3 years. | Adverse events are monitored and graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate | Four weeks after ATO-combined induction chemotherapy | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Survival Rate | 3 years. | 1 patient lost to follow-up for OS. | percentage of participent | NUMBER |
| SECONDARY | Progression Free Survival Rate | 3 years. | 6 patients lost to follow-up for PFS. | percentage of participent | NUMBER |
| SECONDARY | Number of Participants With Adverse Events | From date of ATO-combined chemotherapy until the date of first documented adverse event, and follow up for 3 years. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate | ATO-combined Chemotherapy | 62 | Participants | ||
| Overall Survival Rate | ATO-combined Chemotherapy | 68.0 | 95% Confidence Interval 53.8 to 78.6 | percentage of participent | |
| Progression Free Survival Rate | ATO-combined Chemotherapy | 47.7 | 95% Confidence Interval 32.5 to 61.4 | percentage of participent | |
| Number of Participants With Adverse Events | Myelosuppression | 60 | Participants | ||
| Number of Participants With Adverse Events | Vomiting | 33 | Participants | ||
| Number of Participants With Adverse Events | Transaminitis | 4 | Participants | ||
| Number of Participants With Adverse Events | Cardiovascular Toxicity | 1 | Participants | ||
| Number of Participants With Adverse Events | Infection | 20 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ATO-combined Chemotherapy | 80 | |
| Overall Study | COMPLETED | ATO-combined Chemotherapy | 67 | |
| Overall Study | NOT COMPLETED | ATO-combined Chemotherapy | 13 |
Source ClinicalTrials.gov
Adverse events5
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 | Myelosuppression | Blood and lymphatic system disorders | ATO-combined Chemotherapy | 67 | 67 | |
| other | Vomiting | Gastrointestinal disorders | ATO-combined Chemotherapy | 54 | 67 | |
| other | Infection | Infections and infestations | ATO-combined Chemotherapy | 23 | 67 | |
| other | Transaminitis | Hepatobiliary disorders | ATO-combined Chemotherapy | 23 | 67 | |
| other | Cardiovascular toxicity | Cardiac disorders | ATO-combined Chemotherapy | 10 | 67 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ATO-combined Chemotherapy | 22 | 67 |
| Total, other adverse events | ATO-combined Chemotherapy | 67 | 67 |
| Total, serious adverse events | ATO-combined Chemotherapy | 0 | 67 |
Source ClinicalTrials.gov
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT03503864
GET https://conductscience.org/api/trials/v1/NCT03503864/registered