Trial · NCT02281955
De-intensification of Radiation and Chemotherapy for Low-Risk HPV-related Oropharyngeal SCC: Follow-up Study
NCT02281955, Phase 2, Completed, UNC Lineberger Comprehensive Cancer Center; results first posted 2020-12-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. De-intensification of Radiation and Chemotherapy for Low-Risk HPV-related Oropharyngeal SCC: Follow-up Study. Trials, record NCT02281955. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02281955
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- De-intensification of Radiation and Chemotherapy for Low-Risk HPV-related Oropharyngeal SCC: Follow-up Study
- NCT number
- NCT02281955
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 115 participants, actual
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Conditions
- Carcinoma, Squamous Cell, Head and Neck Neoplasms, Oropharyngeal Neoplasms
- Interventions
- Intensity Modulated Radiotherapy (IMRT), Cisplatin (or alternative), Assessment for surgical evaluation
- First posted
- 2014-11-04
- Last updated
- 2025-01-07
- Results first posted
- 2020-12-22
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 2 Year Progression Free Survival After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC) | Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks) | Progression Free Survival (PFS) was defined as the time from the beginning of treatment to cancer progression or death. The outcome measure will be reported as the proportion of patients with PFS at 2 years post-treatment. |
| Secondary | 2 Year Local Control (LC) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC) | Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks). | The outcome measure will be reported as the proportion of patients with LC at 2 years post-treatment. |
| Secondary | 2 Year Regional Control (RC) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC) | Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks). | The outcome measure will be reported as the proportion of patients with RC at 2 years post-treatment. |
| Secondary | 2 Year Local-regional Control (LRC) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC) | Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks). | The outcome measure will be reported as the proportion of patients with LRC at 2 years post-treatment. |
| Secondary | 2 Year Distant Metastasis Free Survival (DMFS) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC) | Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks). | The outcome measure will be reported as the proportion of patients with DMFS at 2 years post-treatment. |
| Secondary | 2 Year Overall Survival (OS) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC) | Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks). | The outcome measure will be reported as the proportion of patients who are still alive (overall survival) at 2 years post-treatment. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 2 Year Progression Free Survival After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC) | Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 2 Year Local Control (LC) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC) | Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks). | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 2 Year Regional Control (RC) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC) | Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks). | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 2 Year Local-regional Control (LRC) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC) | Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks). | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 2 Year Distant Metastasis Free Survival (DMFS) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC) | Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks). | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 2 Year Overall Survival (OS) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC) | Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks). | Note that the count provided here represents actuarial data and thus does not match the all-cause mortality count in the Adverse Events module. | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| 2 Year Progression Free Survival After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC) | De-escalated Radiation and Chemotherapy | 99 | Participants | ||
| 2 Year Local Control (LC) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC) | De-escalated Radiation and Chemotherapy | 107 | Participants | ||
| 2 Year Regional Control (RC) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC) | De-escalated Radiation and Chemotherapy | 110 | Participants | ||
| 2 Year Local-regional Control (LRC) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC) | De-escalated Radiation and Chemotherapy | 105 | Participants | ||
2 Year Distant Metastasis Free Survival (DMFS) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC) | De-escalated Radiation and Chemotherapy | 103 | Participants | ||
| 2 Year Overall Survival (OS) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC) | De-escalated Radiation and Chemotherapy | 106 | 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 | De-escalated Radiation and Chemotherapy | 114 | |
| Overall Study | COMPLETED | De-escalated Radiation and Chemotherapy | 113 | |
| Overall Study | NOT COMPLETED | De-escalated Radiation and Chemotherapy | 1 |
Source ClinicalTrials.gov
Adverse events34
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 | De-escalated Radiation and Chemotherapy | 1 | 114 | |
| other | Acute kidney injury | Renal and urinary disorders | De-escalated Radiation and Chemotherapy | 1 | 114 | |
| other | Anorexia | Metabolism and nutrition disorders | De-escalated Radiation and Chemotherapy | 26 | 114 | |
| other | Anxiety | Psychiatric disorders | De-escalated Radiation and Chemotherapy | 3 | 114 | |
| other | Aspiration | Respiratory, thoracic and mediastinal disorders | De-escalated Radiation and Chemotherapy | 1 | 114 | |
| other | Dehydration | Metabolism and nutrition disorders | De-escalated Radiation and Chemotherapy | 5 | 114 | |
| other | Depression | Psychiatric disorders | De-escalated Radiation and Chemotherapy | 1 | 114 | |
| other | Dermatitis radiation | Injury, poisoning and procedural complications | De-escalated Radiation and Chemotherapy | 3 | 114 | |
| other | Dry mouth | Gastrointestinal disorders | De-escalated Radiation and Chemotherapy | 3 | 114 | |
| other | Dysphagia | Gastrointestinal disorders | De-escalated Radiation and Chemotherapy | 25 | 114 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | De-escalated Radiation and Chemotherapy | 5 | 114 |
| Total, other adverse events | De-escalated Radiation and Chemotherapy | 59 | 114 |
| Total, serious adverse events | De-escalated Radiation and Chemotherapy | 0 | 114 |
Source ClinicalTrials.gov
Papers2
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/NCT02281955
GET https://conductscience.org/api/trials/v1/NCT02281955/events?page=2