Oropharyngeal NeoplasmsPhase 3ADEPTNCT01687413
Post Operative Adjuvant Therapy De-intensification Trial for Human Papillomavirus-related, p16+ Oropharynx Cancer
A Phase 3 study testing Intensity-modulated radiation therapy (IMRT) and Cisplatin in people with Oropharyngeal Neoplasms, run by Washington University School of Medicine at 2 sites in United States.
Trial summary
This clinical trial studies the intensity of adjuvant ("helper") therapy required in p16 positive oropharynx cancer patients, who have had all known disease removed surgically by a minimally invasive approach, and who have extracapsular spread in their lymph nodes. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Oropharyngeal Neoplasms
- What is being tested?
- Intensity-modulated radiation therapy (IMRT) and Cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Jan 2013to 18 Oct 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have histologically confirmed p16 positive squamous cell carcinoma of the oropharynx (OPSCC).
- Patient must have undergone transoral resection of their T1-4a oropharynx primary to a negative margin, and a neck dissection(s).
- Patient's disease must be pathological N-stage positive.
- Patient's disease must show extracapsular spread (ECS) in their nodal metastasis verified by central pathologist's review.
- Patients with synchronous primaries are included.
- Patients with unknown primaries are included if the diagnosis and resection of a primary site in the oropharynx is made from an endoscopic or robotic surgical procedure(s).
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- Patients with recent excisional node biopsies/neck dissections are included if material is evaluable for extracapsular spread.
- Patient must be ≥ 21 years of age.
- ECOG performance status ≤ 2 (Karnofsky ≥60%).
- Patients must have normal organ and marrow function as defined below:
- leukocytes ≥3,000/mcL
- absolute neutrophil count ≥1,500/mcL
- platelets ≥100,000/mcL
- total bilirubin <1.5 X upper normal institutional limit
- AST(SGOT)/ALT(SGPT) ≤2.5 X institutional upper limit of normal
- creatinine within normal institutional limits OR creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- Patient (or legally authorized representative) must be able to understand and willing to sign a written informed consent document.
Who cannot join
- Patient must not have pathologically N stage negative disease.
- Patient must not have outside nodal tissue from previous neck biopsy/neck dissections in which ECS cannot be confirmed or denied.
- Patient must not have a true unknown primary in which permanent section results are negative for malignancy in completely excised ipsilateral oropharyngeal tissue (palatine and lingual tonsil).
- Patient must not have distant metastatic disease at presentation.
- Patient must not have gross residual and/or microscopic disease present after surgery including re-resection(s), per the operative and pathology report.
- Patient must not have transoral robotic surgery (TORS) for a T3 or T4 primary tumor.
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- Patient must not have a history of prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; noninvasive cancers (for example, carcinoma in situ of the oral cavity, larynx, breast or cervix are all permissible) are permitted even if diagnosed and treated < 3 years ago.
- Patient must not have had previous systemic chemotherapy for the study cancer. (Note: prior chemotherapy for a different cancer is allowable).
- Patient must not be receiving any other investigational agents.
- Patient must not have had any prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- Patient must not have any life-threatening comorbid illnesses e.g. stroke with major sequelae or myocardial infarction/ unstable angina within the preceding 3 months or psychiatric illness/social situations that would limit compliance with study requirements.
- Patient must not be pregnant or breastfeeding. If a woman of childbearing potential, patient must agree to use medically acceptable forms of contraception.
- Both men and women and members of all races and ethnic groups are eligible for this trial.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259-5499
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Adjuvant De-escalation, Extracapsular Spread, P16+, Transoral (ADEPT) Trial for Oropharynx Malignancy
This clinical trial studies the intensity of adjuvant ("helper") therapy required in p16 positive oropharynx cancer patients, who have had all known disease removed surgically by a minimally invasive approach, and who have extracapsular spread in their lymph nodes. Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways. After the surgery, receive either radiation alone, or radiation and weekly cis-platinum during therapy. Patients are then followed for cancer, functional and quality of life outcomes.
- Conditions
- Oropharyngeal Neoplasms
- Being tested
- Intensity-modulated radiation therapy (IMRT), Cisplatin
- Medical subject headings
- Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity-modulated radiation therapy (IMRT)Radiation
CisplatinDrug
Also called CACP, CDDP, CPDD, DDP, Neoplatin
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy | Experimental | * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
* Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways Receives: Radiation: Intensity-modulated radiation therapy (IMRT) |
| Radiotherapy, cisplatin | Active comparator | * Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
* Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
* Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways Receives: Radiation: Intensity-modulated radiation therapy (IMRT); Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Disease-free Survival (DFS)
Measured: 1 year
Locoregional Control
Rate of patients with no recurrence at original oropharyngeal site or in the neck nodal basins.
Measured: Up to 2 years
Secondary outcomes (11)
Rate of Distant Metastasis
Assessed by biopsy or imaging-detected recurrent disease at sites away from the original primary and cervical zone.
Measured: Up to 2 years
Disease Specific Survival
Measured: 1 year
Number of Complications/Acute Toxicity by Organ Class
-Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Measured: Approximately 18 weeks
Change in Quality of Life as Measured by the MD Anderson Dysphagia Inventory
- Each item is scored on a 5 point Likert scale (strongly disagree, disagree, no opinion, agree, strongly agree). Strongly agree = 1, Disagree = 2, No opinion = 3, Agree = 4, and Strongly Agree = 5
- The lower the score the lower the quality of life
Measured: Baseline, 1 month, 6 months, 12 months, and 24 months
Change in Cognitive Function as Measured by Cognitive Failures Questionnaire
- 25 questions to assess the frequency in which participants experience cognitive failures including forgetfulness, distractibility, and false triggering
- Answers range from 0 = never to 4 = very often
- The higher the score the worse the cognitive failures the participant has experienced
Measured: Baseline, 1 month, 12 months, and 24 months
Change in Quality of Life as Measured by Neck Dissection Impairment Index (NDII)
-The NDII consists of 10 questions; each with a 5 level ordinally scaled response option ranging from "not at all" to "a lot". The response for each item is then scored from 1 to 5, with 5 denoting higher quality of life (Not at all) and 1 being the least (A lot).
Measured: Baseline, 12 months, and 24 months
Change in Quality of Life as Measured by University of Michigan Xerostomia Questionnaire
- It contains 8 questions regarding dryness either during feeding or in the unstimulated state. Participants rate each item from 0 to 10, where 10 indicates the maximum dryness or discomfort due to dryness.
- The higher the score the worse the participant's xerostomia
Measured: Baseline, 1 month, 6 months, 12 months, and 24 months
Change in Hearing as Measured by Hearing Handicap Inventory - Adult
- 11 item questionnaire to identify issues with hearing
- Answers are yes = 4, sometimes = 2, and no = 0
- The higher the score the more issues the participant has with hearing
Measured: Baseline, 1 month, and 12 months
Change in Quality of Life as Measured by Scale of Subjective Total Taste Acuity
- 1 question that asks about taste acuity
- Answers are 0 = same taste acuity as before treatment; 1 = mild loss of taste acuity, but not inconvenient in daily life; moderate loss of taste acuity, and sometimes inconvenient in daily life; severe loss of taste acuity, and frequently inconvenient in daily life; and 4 = almost complete or complete loss of taste acuity
- The higher the score the worse the participant's taste acuity
Measured: Baseline, 1 month, 6 months, and 12 months
Change in Quality of Life as Measured by Speech Handicap Index
- 31 questions regarding participant's speech and the effects of speech on his/her life
- The answers for the first 30 questions range from 0 = never to 4 = always and the answers for the 31st question ranges from 0 = excellent to bad = 4
- The higher the score the worse the participant's speech is affecting his/her life
Measured: Baseline and 12 months
Change in Quality of Life as Measured by EORTC QLQ-C30
- 30 questions designed to assess the quality of life of cancer patients
- The first 28 questions have answers that range from 1=not at all to 4 = very much. The higher score indicates a worse quality of life
- The last 2 questions have answers that range from 1 = very poor to 7 = excellent. The higher score indicates a better quality of life
Measured: Baseline, 1 month, 6 months, 12 months, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study start10 Jan 2013
- Primary completion18 Oct 2019
- Study completion18 Oct 2019
Why it stopped: Slow accrual and funding issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oropharyngeal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Foundation for Barnes-Jewish Hospital
- Responsible party
- Sponsor
- Investigators
- Jason Rich, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01687413
- Sponsor's protocol ID
- 201207059
- Acronym
- ADEPT
- Status last verified
- Nov 2020
- First submitted
- 13 Sep 2012
- Last updated
- 25 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Psyrri A, Rampias T, Vermorken JB. The current and future impact of human papillomavirus on treatment of squamous cell carcinoma of the head and neck. Ann Oncol. 2014 Nov;25(11):2101-2115. doi: 10.1093/annonc/mdu265. Epub 2014 Jul 23.
PubMed 25057165
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant De-escalation, Extracapsular Spread, P16+, Transoral (ADEPT) Trial for Oropharynx Malignancy
- ClinicalTrials.gov ID
- NCT01687413
- Acronym / sponsor ID
- ADEPT / 201207059
- Conditions
- Oropharyngeal Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual and funding issues
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- The Foundation for Barnes-Jewish Hospital
- Study start
- 10 Jan 2013 (actual)
- Primary completion
- 18 Oct 2019 (actual)
- Study completion
- 18 Oct 2019 (actual)
- First posted
- 18 Sep 2012 (estimated)
- Results
- Posted 10 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial studies the intensity of adjuvant ("helper") therapy required in p16 positive oropharynx cancer patients, who have had all known disease removed surgically by a minimally invasive approach, and who have extracapsular spread in their lymph nodes. Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways. After the surgery, receive either radiation alone, or radiation and weekly cis-platinum during therapy. Patients are then followed for cancer, functional and quality of life outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy | Experimental | Radiation: Intensity-modulated radiation therapy (IMRT)* Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways |
| Radiotherapy, cisplatin | Active comparator | Radiation: Intensity-modulated radiation therapy (IMRT), Drug: Cisplatin* Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) * Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). * Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patient must have histologically confirmed p16 positive squamous cell carcinoma of the oropharynx (OPSCC).
- Patient must have undergone transoral resection of their T1-4a oropharynx primary to a negative margin, and a neck dissection(s).
- Patient's disease must be pathological N-stage positive.
- Patient's disease must show extracapsular spread (ECS) in their nodal metastasis verified by central pathologist's review.
- Patients with synchronous primaries are included.
Key exclusion criteria (13 listed)
- Patient must not have pathologically N stage negative disease.
- Patient must not have outside nodal tissue from previous neck biopsy/neck dissections in which ECS cannot be confirmed or denied.
- Patient must not have a true unknown primary in which permanent section results are negative for malignancy in completely excised ipsilateral oropharyngeal tissue (palatine and lingual tonsil).
- Patient must not have distant metastatic disease at presentation.
- Patient must not have gross residual and/or microscopic disease present after surgery including re-resection(s), per the operative and pathology report.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensity-modulated radiation therapy (IMRT) | Radiation | Radiotherapy, Radiotherapy, cisplatin |
| CisplatinAlso: CACP, CDDP, CPDD, DDP, Neoplatin | Drug | Radiotherapy, cisplatin |
Primary outcome
Number of Participants With Disease-free Survival (DFS)
Time frame: 1 year
Locoregional Control
Time frame: Up to 2 years
Rate of patients with no recurrence at original oropharyngeal site or in the neck nodal basins.
11 secondary outcomes
Rate of Distant Metastasis
Time frame: Up to 2 years
Disease Specific Survival
Time frame: 1 year
Number of Complications/Acute Toxicity by Organ Class
Time frame: Approximately 18 weeks
Change in Quality of Life as Measured by the MD Anderson Dysphagia Inventory
Time frame: Baseline, 1 month, 6 months, 12 months, and 24 months
Change in Cognitive Function as Measured by Cognitive Failures Questionnaire
Time frame: Baseline, 1 month, 12 months, and 24 months
Change in Quality of Life as Measured by Neck Dissection Impairment Index (NDII)
Time frame: Baseline, 12 months, and 24 months
Change in Quality of Life as Measured by University of Michigan Xerostomia Questionnaire
Time frame: Baseline, 1 month, 6 months, 12 months, and 24 months
Change in Hearing as Measured by Hearing Handicap Inventory - Adult
Time frame: Baseline, 1 month, and 12 months
Change in Quality of Life as Measured by Scale of Subjective Total Taste Acuity
Time frame: Baseline, 1 month, 6 months, and 12 months
Change in Quality of Life as Measured by Speech Handicap Index
Time frame: Baseline and 12 months
Change in Quality of Life as Measured by EORTC QLQ-C30
Time frame: Baseline, 1 month, 6 months, 12 months, and 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25057165Psyrri A, Rampias T, Vermorken JB. The current and future impact of human papillomavirus on treatment of squamous cell carcinoma of the head and neck. Ann Oncol. 2014 Nov;25(11):2101-2115. doi: 10.1093/annonc/mdu265. Epub 2014 Jul 23.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Rich, MD principal investigator
Washington University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intensity-modulated radiation therapy (IMRT) and Cisplatin in people with Oropharyngeal Neoplasms, run by Washington University School of Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Disease-free Survival (DFS) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01687413, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2020.