Trial · NCT01525927
Study of Chemotherapy Prior to Radiotherapy and Chemotherapy in Patients With HPV Associated Cancer of the Oral Cavity
NCT01525927, Phase 2, Terminated, Northwell Health; results first posted 2015-09-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Chemotherapy Prior to Radiotherapy and Chemotherapy in Patients With HPV Associated Cancer of the Oral Cavity. Trials, record NCT01525927. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01525927
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Chemotherapy Prior to Radiotherapy and Chemotherapy in Patients With HPV Associated Cancer of the Oral Cavity
- NCT number
- NCT01525927
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 2 participants, actual
- Lead sponsor
- Northwell Health
- Conditions
- Oropharyngeal Neoplasms
- Interventions
- chemotherapy, radiotherapy, Reduced dose radiotherapy
- First posted
- 2012-02-03
- Last updated
- 2017-12-19
- Results first posted
- 2015-09-30
- Limitations and caveats
- Study terminated , PI left the institution, no data analyzed
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response (CR+PR) Status at 3 Months Post-therapy | 3 months following completion of radiation phase | The 3-month response rate will be estimated using standard methods for estimating proportions and their 95% one-sided confidence intervals (CIs). Comparison to the historical control data will be carried out using a chi-square test for comparing proportions (or a Fisher exact test if an expected cell frequency in the 2x2 table is less than 5). Zero (0) participants analyzed |
| Secondary | To Define Objective Tumor Response Rates to Induction Chemotherapy and to Subsequent Radiation-based Treatment. | Three months following completion of radiation therapy phase. | To define objective tumor response rates to induction chemotherapy and to subsequent radiation-based treatment, per RESIST version 1.1 criteria. |
| Secondary | Progression-free Survival at 2 Years | At two years following completion of radiation phase | assess Progression-free survival at 2 years. |
| Secondary | Assess Overall Survival at 2 Years. | At two years following completion of radiation phase | To assess overall survival at 2 years. |
| Secondary | Assess Locoregional Disease Control at 2 Years | At two years following completion of radiation phase | To assess locoregional disease control at 2 years |
| Secondary | Assess Distant Disease Control at 2 Years. | At two years following completion of radiation phase | 3.5 To assess distant disease control at 2 years. |
| Secondary | Assessment of Quality of Life Outcomes | Baseline, during therapy and up to two years following completion of radiation phase | Serial evaluation of functional quality-of-life, including M. D. Anderson Dysphagia Inventory (MDADI) and Oropharyngeal swallowing efficiency (OPSE) measures of swallowing function, as well as formal sialometric measurement of parotid function. |
| Secondary | Identify Additional Toxicity of Treatment | During therapy and up to 5 years following completion of treatment | To identify additional toxicity of treatment |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response (CR+PR) Status at 3 Months Post-therapy | 3 months following completion of radiation phase | No study intervention or data collected. | ||
| SECONDARY | To Define Objective Tumor Response Rates to Induction Chemotherapy and to Subsequent Radiation-based Treatment. | Three months following completion of radiation therapy phase. | |||
| SECONDARY | Progression-free Survival at 2 Years | At two years following completion of radiation phase | No study intervention or data collected- Zero (0) participants analyzed | ||
| SECONDARY | Assess Overall Survival at 2 Years. | At two years following completion of radiation phase | No study intervention or data collected- Zero (0) participants analyzed | ||
| SECONDARY | Assess Locoregional Disease Control at 2 Years | At two years following completion of radiation phase | No study intervention or data collected- Zero (0) participants analyzed | ||
| SECONDARY | Assess Distant Disease Control at 2 Years. | At two years following completion of radiation phase | No study intervention or data collected- Zero (0) participants analyzed | ||
| SECONDARY | Assessment of Quality of Life Outcomes | Baseline, during therapy and up to two years following completion of radiation phase | No study intervention or data collected- Zero (0) participants analyzed | ||
| SECONDARY | Identify Additional Toxicity of Treatment | During therapy and up to 5 years following completion of treatment | No study intervention or data collected- Zero (0) participants analyzed |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chemotherapy Responders | 0 | |
| Overall Study | COMPLETED | Chemotherapy Responders | 0 | |
| Overall Study | NOT COMPLETED | Chemotherapy Responders | 0 |
Source ClinicalTrials.gov
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 totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chemotherapy Non-responders | ||
| Total, all-cause mortality | Chemotherapy Responders | ||
| Total, other adverse events | Chemotherapy Non-responders | 0 | 0 |
| Total, other adverse events | Chemotherapy Responders | 0 | 0 |
| Total, serious adverse events | Chemotherapy Non-responders | 0 | 0 |
| Total, serious adverse events | Chemotherapy Responders | 0 | 0 |
Source ClinicalTrials.gov
Papers16
The papers the trial lists on ClinicalTrials.gov.
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/NCT01525927
GET https://conductscience.org/api/trials/v1/NCT01525927/registered