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Human Papilloma VirusNCT02072148

The Sinai Robotic Surgery Trial in HPV Positive Oropharyngeal Squamous Cell Carcinoma (SCCA) (SIRS TRIAL)

A study testing PET/CT, Radiotherapy and Concurrent Chemoradiation in people with Human Papilloma Virus and Oropharyngeal Squamous Cell Carcinoma, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

In general, patients with Human Papilloma Virus Positive Oropharyngeal Squamous Cell Carcinoma (HPVOPC) are curable, young and will live for prolonged periods. They are at high risk for long-term toxicity and mortality from therapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PET/CT, Radiotherapy and Concurrent Chemoradiation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
2 sitesUnited States
Study dates
Mar 2014to 12 May 2022
Phase
Interventional

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients may be screened and consented if they display clinical features that are consistent with p16 positivity, they are p16+ but and not yet tested for p16 by IHC and for HPV by PCR and if they meet the other eligibility criteria. They will enter the experimental post-surgical portion of the study if they have surgery performed at MSSM and surgical specimens or biopsies proven to be both p16+ on IHC testing and HPV+ on PCR testing
  • Participants must have histologically or cytologically confirmed and identified resectable primary squamous cell carcinoma of the oropharynx that is HPV 16 positive or positive for any high risk HPV subtype (i.e., 18, 33, 35, etc.) as determined by PCR at the central laboratory. Patients must have p16+ status as determined by IHC performed or reviewed at the central laboratory prior to consent. Both p16 and HPV status must be determined prior to post-surgical adjuvant treatment assignment. Tissue from the primary site must be available for biomarker studies after surgery.
  • Stage 1, 2, 3 or early and intermediate stage IVa (T1N0-2B, T2N0-2B) (Level 2, non-matted) disease without evidence distant metastases or extracapsular extension. Primary site must be lateralized for a functional dissection.
  • Age > 18 years.
  • No previous surgery, radiation therapy or chemotherapy for SCCHN (other than biopsy or tonsillectomy) is allowed at time of study entry.
  • ECOG performance status of 0 or 1.
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  • No active alcohol addiction (as assessed by medical caregiver).
  • No active tobacco use (>10 years tobacco free interval, <20pk/yr. history)
  • Ability to understand and the willingness to sign a written informed consent document.
  • Participants must have adequate bone marrow, hepatic and renal functions as defined below:
  • Hematology:
  • Neutrophil count > 1.5 x 109/l.
  • Platelet count > 100 x 109/l.
  • Hemoglobin > 10 g/dl (may achieve by transfusion).
  • Renal function: > 60 ml/min (actual or calculated by the Cockcroft-Gault method) as follows:
  • CrCl (mL/min) = (140-age) (weight kg)
  • 72 x serum creatinine (mg/dL)
  • N.B. For females, use 85% of calculated CrCl value.
  • Or a Creatinine < the upper limits of normal

Who cannot join

  • Patients < age 18.
  • Pregnant or breast feeding women.
  • Previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix, basal or squamous cell carcinoma of the skin, thyroid cancer, or other cancer curatively treated by surgery and with no current evidence of disease for at least 5 years.
  • Other serious illnesses or medical conditions including but not limited to:
  • Unstable cardiac disease despite treatment, myocardial infarction with months prior to study entry.
  • History of significant neurologic or psychiatric disorders including dementia or seizures
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  • Active clinically significant uncontrolled infection
  • Active peptic ulcer disease defined as unhealed or clinically active
  • Active drug addiction including alcohol, cocaine or intravenous drug use defined as occurring within the 6 months preceding diagnosis
  • Chronic Obstructive Pulmonary Disease, defined as being associated with a hospitalization for pneumonia or respiratory decompensation within 12 months of diagnosis. This does not include obstruction from tumor
  • Autoimmune disease requiring therapy, prior organ transplant, or known HIV infection
  • Interstitial lung disease
  • Hepatitis C by history
  • Concurrent treatment with any other anticancer therapy.
  • Participation in an investigational therapeutic drug trial within 30 days of study entry.
  • Advanced Stage III,IV (N2C, N3) or surgically unresectable disease or disease that cannot be fully resected, obvious radiologic ECS, supraclavicular or matted metastatic disease, >3 cervical nodes. (These patients will be placed on the Quarterback trial due to advanced state of disease and poor prognostic features)
  • HPV negative OPSCC as determined by determined by PCR.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Mount Sinai Beth Israel

    New York, New York, 10003

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

Other trials in United States

About this study

Official title: The Sinai Robotic Surgery Trial in HPV Positive Oropharyngeal Squamous Cell Carcinoma (SCCA)

In general, patients with Human Papilloma Virus Positive Oropharyngeal Squamous Cell Carcinoma (HPVOPC) are curable, young and will live for prolonged periods. They are at high risk for long-term toxicity and mortality from therapy. While the long-term consequences of chemotherapy and surgery for head and neck cancer are relatively constrained, high-dose radiotherapy (RT) and chemoradiotherapy (CRT) substantially impact on local tissues and organ function and result in a significant rate of late mortality and morbidity in patients. Studies are now being designed to reduce the impact of RT and CRT for patients.

Patients with intermediate stage HPV positive oropharyngeal cancer will be screened for poor prognostic features and undergo robotic surgery. Patients in whom pathology demonstrates good prognosis features will then be followed without postoperative radiotherapy. Patients with subsequent recurrence will be treated with either surgery and postoperative radiotherapy or postoperative chemoradiotherapy alone. Patients with poor prognostic features (ECS, LVI, PNI) will receive reduced dose radiotherapy or chemoradiotherapy based on pathology. It is expected that over 50% of patients treated with surgery will have had a curative treatment and will avoid radiation therapy entirely and long-term survival will not be changed by withholding radiation therapy to good prognosis patients after surgery. There are exploratory biomarkers of risk of recurrence that will be collected and studied.

There are currently few trials examining the role of de-escalation using surgery alone in intermediate and early T-stage HPV related disease. New surgical techniques have broadened the range of patients capable of achieving a complete resection and the functional outcomes in such patients are outstanding. Furthermore, the sensitivity of HPVOPC to chemotherapy and radiotherapy raise the possibility that delayed or salvage treatment in early stage patients would be highly effective, would result in similar survival outcomes and radiotherapy could be applied to a much smaller population then current standards call for. Looked at from a different perspective, the need for post-operative radiotherapy in this younger, HPV+ and more functional population has not been validated in clinical trials to date.

Being tested
PET/CT, Radiotherapy, Concurrent Chemoradiation
Keywords
Human Papilloma Virus, Oropharyngeal Squamous Cell Carcinoma, Transoral Robotic Surgery
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PET/CTProcedure or surgery

    PET scan or CT scan q 4 months for 5 years

  • RadiotherapyRadiation

    Also called RT, XRT

    Postoperative XRT 5000 cGy

  • Concurrent ChemoradiationRadiation

    Also called CCRT, Cisplatin

    CCRT with cisplatin 40mg/m2/week IV over approximately 30 minutes, mixed in 250ml normal saline Weekly on Monday or Tuesday any time, or Wednesday prior to radiation

    Postoperative XRT 5000 cGy

  • Concurrent ChemoradiationRadiation

    Also called CCRT, Cisplatin

    CCRT with cisplatin 40mg/m2/week IV over approximately 30 minutes, mixed in 250ml normal saline Weekly on Monday or Tuesday any time, or Wednesday prior to radiation

    Postoperative XRT 5600 cGy

Study groups in NCT02072148
Study groupRoleWhat they receive
Low Risk Group IExperimentalGroup I: * Complete resection (margins: tonsil >1mm, tongue >3mm, pT1-2, pN0-2B), * No LVI, no PNI, <3 positive nodes. * No ECS, No matted or Level >III,
Receives: Procedure: PET/CT
Intermediate Risk Group IIExperimentalGroup II * Complete resection (margins: tonsil <1mm, tongue <1mm, pT1-2, pN0-2B), * +LVI, +PNI, <3 positive nodes. ≤1mm ECS.
Receives: Procedure: PET/CT; Radiation: Radiotherapy
High Risk Group IIIAExperimental* 3+ nodes, no ECS > 1mm * Contralateral or supraclavicular nodes
Receives: Procedure: PET/CT; Radiation: Concurrent Chemoradiation
High Risk Group IIIBExperimental* Incomplete surgical resection with + surgical margins * ≥ 1 mm ECS * Matted nodes
Receives: Procedure: PET/CT; Radiation: Concurrent Chemoradiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease Specific Survival (DSS)

    Number of participants with HPV related oropharynx cancer treated with a de-intensified adjuvant protocol with status of disease specific survival. DSS was calculated by measuring the time from trial entry to cancer-related death.

    Measured: 5 years

  2. Number of Participants With Progression-Free Survival (PFS)

    Number of participants with HPV related oropharynx cancer treated with a de-intensified adjuvant protocol with status of progression-free survival. PFS calculated the time to biopsy confirmed recurrence or death from any cause.

    Measured: 5 years

  3. Number of Participants With Locoregional Failures (LRFs)

    the rate of local regional control (LRC) in patients with early and intermediate stage HPV related oropharynx cancer treated with surgery alone as assessed by number of participants with locoregional failures.

    Measured: 5 years

Secondary outcomes (3)

  1. Overall Survival

    Overall survival (OS) in patients with early and intermediate stage HPV related oropharynx cancer treated with surgery alone. OS from the time of entry to death with any cause.

    Measured: 5 years

  2. Number of Serious Adverse Events

    Number of serious adverse events

    Measured: 5 years

  3. Global Quality of Life Scores

    Global Quality of Life Scores total score from 0-100, with higher score indicating better health outcomes.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2014 (estimated)
  2. Study startMar 2014
  3. Primary completion12 May 2022
  4. Study completion12 May 2022

Resources

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 N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02072148
Sponsor's protocol ID
GCO 13-1662
Status last verified
May 2024
First submitted
24 Feb 2014
Last updated
6 May 2024
Data monitoring committee
Yes

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