Trial · NCT01470248
Study of Arsenic Trioxide in Small Cell Lung Cancer
NCT01470248, Phase 2, Completed, Emory University; results first posted 2017-03-08
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Study of Arsenic Trioxide in Small Cell Lung Cancer. Trials, record NCT01470248. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01470248
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Arsenic Trioxide in Small Cell Lung Cancer
- NCT number
- NCT01470248
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Emory University
- Conditions
- Lung Cancer, Cancer of Lung, Pulmonary Cancer, Pulmonary Neoplasms, Carcinoma, Small Cell
- Interventions
- Arsenic Trioxide
- First posted
- 2011-11-11
- Last updated
- 2021-02-17
- Results first posted
- 2017-03-08
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate (RR) | Every 8 weeks | Response rate (complete response \[CR\]+ partial response \[PR\]) was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). * Complete response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. * Partial response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. * Progressive disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. * Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Primary | Clinical Benefit Rate (CBR) | After completing at least 1 cycle (8 weeks) of treatment | Sum of complete response (CR), partial response (PR) and stable disease (SD) in patients eligible for efficacy analysis. |
| Secondary | Progression-free Survival | Every 8 weeks | Defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Secondary | Overall Survival | From enrolment till death on average up to 2 years | Duration of time from enrollment on study until death |
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 | Response Rate (RR) | Every 8 weeks | Two patients were not analyzed because only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated were considered evaluable for response. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Clinical Benefit Rate (CBR) | After completing at least 1 cycle (8 weeks) of treatment | An alternative endpoint of clinical benefit rate was pre-specified in the event that the study failed to meet its overall response rate (ORR) endpoint either at the end of stage I accrual or at final analysis. However, this study met its endpoint. Please see primary outcome measure 1. | ||
| SECONDARY | Progression-free Survival | Every 8 weeks | Two patients were not analyzed because only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated were considered evaluable for response. | weeks | MEAN |
| SECONDARY | Overall Survival | From enrolment till death on average up to 2 years | Two patients were not analyzed because only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated were considered evaluable for response. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate (RR) | Arsenic Trioxide Treatment | Complete response | 0 | Participants | |
| Response Rate (RR) | Arsenic Trioxide Treatment | Partial response | 0 | Participants | |
| Response Rate (RR) | Arsenic Trioxide Treatment | Stable disease | 2 | Participants | |
| Response Rate (RR) | Arsenic Trioxide Treatment | Progressive disease | 15 | Participants | |
| Progression-free Survival | Arsenic Trioxide Treatment | 6.26 | Standard Deviation 3.9 | weeks | |
| Overall Survival | Arsenic Trioxide Treatment | 4.5 | Full Range 2 to 7 | months |
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 | Arsenic Trioxide Treatment | 20 | |
| Overall Study | COMPLETED | Arsenic Trioxide Treatment | 19 | |
| Overall Study | NOT COMPLETED | Arsenic Trioxide Treatment | 1 |
Source ClinicalTrials.gov
Adverse events18
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 | Dyspnea | Respiratory, thoracic and mediastinal disorders | Arsenic Trioxide Treatment | 1 | 19 | |
| other | Anemia | Blood and lymphatic system disorders | Arsenic Trioxide Treatment | 1 | 19 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Arsenic Trioxide Treatment | 1 | 19 | |
| other | Elevated creatinine | Renal and urinary disorders | Arsenic Trioxide Treatment | 1 | 19 | |
| other | Facial edema around eyes | Skin and subcutaneous tissue disorders | Arsenic Trioxide Treatment | 1 | 19 | |
| other | Generalized weakness | General disorders | Arsenic Trioxide Treatment | 1 | 19 | |
| other | Hyperbilirubinemia | Blood and lymphatic system disorders | Arsenic Trioxide Treatment | 2 | 19 | |
| other | Hyperglycemia | Metabolism and nutrition disorders | Arsenic Trioxide Treatment | 1 | 19 | |
| other | Hypoalbuminemia | Blood and lymphatic system disorders | Arsenic Trioxide Treatment | 3 | 19 | |
| other | Hypocalcemia | Blood and lymphatic system disorders | Arsenic Trioxide Treatment | 1 | 19 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arsenic Trioxide Treatment | ||
| Total, other adverse events | Arsenic Trioxide Treatment | 7 | 19 |
| Total, serious adverse events | Arsenic Trioxide Treatment | 1 | 19 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27142472 | RESULT |
Source PubMed
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 |
|---|---|---|---|---|---|
| K23CA164015 | Novel systemic therapy to improve clinical outcome in small cell lung cancer | OWONIKOKO, TAOFEEK K | EMORY UNIVERSITY | NATIONAL CANCER INSTITUTE | 2011 to 2015 |
Source NIH RePORTER
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/NCT01470248
GET https://conductscience.org/api/trials/v1/NCT01470248/registered