```

[Federal Register Volume 79, Number 48 (Wednesday, March 12, 2014)]
[Notices]
[Pages 14046-14047]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05389]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality

Scientific Information Request on Radiotherapy Treatments for 
Head and Neck Cancer

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for scientific information submissions.

-----------------------------------------------------------------------

SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from the public on 3-
Dimensionsal Conformal Radiotherapy (3DRT), Intensity-Modulated 
Radiotherapy (IMRT), Stereotactic Body Radiotherapy (SBRT), and Proton 
Beam Radiotherapy (PBRT). Scientific information is being solicited to 
inform our update review of Radiotherapy Treatments for Head and Neck 
Cancer, which is currently being conducted by the Evidence-based 
Practice Centers for the AHRQ Effective Health Care Program. Access to 
published and unpublished pertinent scientific information on 3-
Dimensionsal Conformal Radiotherapy (3DRT), Intensity-Modulated 
Radiotherapy (IMRT), Stereotactic Body Radiotherapy (SBRT), and Proton 
Beam Radiotherapy (PBRT) will improve the quality of this review. AHRQ 
is conducting this comparative effectiveness review pursuant to Section 
1013 of the Medicare Prescription Drug, Improvement, and Modernization 
Act of 2003, Public Law 108-173, and Section 902(a) of the Public 
Health Service Act, 42 U.S.C. 299a(a).

DATES: Submission Deadline on or before April 11, 2014.

ADDRESSES: 
    Online submissions: http://effectivehealthcare.AHRQ.gov/index.cfm/submit-scientific-information-packets/. Please select the study for 
which you are submitting information from the list to upload your 
documents.
    Email submissions: /src.org">src.org">SIPS@epc-src.org.
    Print submissions:
    Mailing Address: Portland VA Research Foundation, Scientific 
Resource Center, ATTN: Scientific Information Packet Coordinator, P.O. 
Box 69539, Portland, OR 97239.
    Shipping Address (FedEx, UPS, etc.): Portland VA Research 
Foundation, Scientific Resource Center, ATTN: Scientific Information 
Packet Coordinator, 3710 SW U.S. Veterans Hospital Road, Mail Code: R&D 
71, Portland, OR 97239.

FOR FURTHER INFORMATION CONTACT: Robin Paynter, Research Librarian, 
Telephone: 503-220-8262 ext. 58652 or Email: /src.org">src.org">SIPS@epc-src.org.

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Effective Health Care (EHC) Program 
Evidence-based Practice Centers to complete an updated review of the 
evidence for Radiotherapy Treatments for Head and Neck Cancer.
    The EHC Program is dedicated to identifying as many studies as 
possible that are relevant to the questions for each of its reviews. In 
order to do so, we are supplementing the usual manual and electronic 
database searches of the literature by requesting information from the 
public (e.g., details of studies conducted). We are looking for studies 
that report on Radiotherapy Treatments for Head and Neck Cancer, 
including those that describe adverse events. The entire research 
protocol, including the key questions, is also available online at: 
http://effectivehealthcare.AHRQ.gov/ehc/products/569/1852/head-neck-cancer-update-140204.pdf.
    This notice is to notify the public that the EHC program would find 
the following information on 3-Dimensionsal Conformal Radiotherapy 
(3DRT), Intensity-Modulated Radiotherapy (IMRT), Stereotactic Body 
Radiotherapy (SBRT), and Proton Beam Radiotherapy (PBRT) helpful:
     A list of completed studies your company has sponsored for 
this indication. In the list, indicate whether results are available on 
ClinicalTrials.gov along with the ClinicalTrials.gov trial number.
     For completed studies that do not have results on 
ClinicalTrials.gov, a summary, including the following elements: study 
number, study period, design, methodology, indication and diagnosis, 
proper use instructions, inclusion and exclusion criteria, primary and 
secondary outcomes, baseline characteristics, number of patients 
screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, 
effectiveness/efficacy, and safety results.
     A list of ongoing studies your company has sponsored for 
this indication. In the list, please provide the ClinicalTrials.gov 
trial number or, if the trial is not registered, the protocol for the 
study including a study number, the study period, design, methodology, 
indication and diagnosis, proper use instructions, inclusion and 
exclusion criteria, and primary and secondary outcomes.
     Description of whether the above studies constitute ALL 
Phase II and above clinical trials sponsored by your company for this 
indication and an index outlining the relevant information in each 
submitted file.
    Your contribution is very beneficial to the Program. The contents 
of all submissions will be made available to the public upon request. 
Materials submitted must be publicly available or can be made public. 
Materials that are considered confidential; marketing materials; study 
types not included in the review; or information on indications not 
included in the review cannot be used by the Effective Health Care 
Program. This is a voluntary request for information, and all costs for 
complying with this request must be borne by the submitter.
    The draft of this review will be posted on AHRQ's EHC program Web 
site and available for public comment for a period of 4 weeks. If you 
would like to be notified when the draft is posted, please sign up for 
the email list at: http://effectivehealthcare.AHRQ.gov/index.cfm/join-the-email-list1/.
    The systematic review will answer the following questions. This 
information is provided as background. AHRQ is not requesting that the 
public provide answers to these questions. The entire research 
protocol, is also available online at: http://effectivehealthcare.AHRQ.gov/ehc/products/569/1852/head-neck-cancer-update-140204.pdf

Key Questions (KQs)

Key Question 1

    What is the comparative effectiveness of 3DRT, IMRT, SBRT, and PBRT 
regarding adverse events and quality of life (QoL)?

[[Page 14047]]

Key Question 2

    What is the comparative effectiveness of 3DRT, IMRT, SBRT, and PBRT 
regarding tumor control and patient survival?

Key Question 3

    Are there differences in comparative effectiveness of 3DRT, IMRT, 
SBRT, and PBRT for specific patient and tumor characteristics?

Key Question 4

    Is there variation in comparative effectiveness of 3DRT, IMRT, 
SBRT, and PBRT because of differences in user experience, treatment 
planning, treatment delivery, and target volume delineation?

PICOTS (Population, Intervention, Comparator(s), Outcomes, Timing, 
Setting)

    Identify for each key question:

Population(s)

    KQs 1-4: Populations of interest include patients with head and 
neck cancer. To define what constitutes head and neck cancer, we 
consulted clinical resources such as the National Cancer Institute's 
Physician Data Query (PDQ) Cancer Information Summary and the National 
Comprehensive Cancer Network. The consensus definition of head and neck 
cancer includes tumors of:

1. larynx
2. pharynx (hypopharynx, oropharyx and nasopharynx)
3. lip and oral cavity
4. paranasal sinus and nasal cavity
5. salivary gland
6. occult primary of the head and neck

    The following tumors are excluded:

1. brain tumors
2. skull base tumors
3. uveal/choroidal melanoma, other ocular and eyelid tumors
4. otologic tumors
5. cutaneous tumors of the head and neck (including melanoma)
6. thyroid cancer
7. parathyroid cancer
8. esophageal cancer
9. trachea tumors

    All therapeutic strategies will be included. Radiotherapy (RT) can 
be delivered as primary (curative) intent therapy or as an adjunct to 
surgery. Chemotherapy can also be given as an adjunct to radiation 
therapy, particularly in patients with more advanced cancer (i.e., 
stages III or IV). We will seek direct evidence for one intervention 
compared to another, with or without chemotherapy or surgery.

Interventions

    The primary interventions of interest in all therapeutic settings 
are:

1. 3 dimensional conformal radiotherapy (3DRT): Defined as any 
treatment plan where CT-based forward treatment planning is used to 
delineate radiation beams and target volumes in three dimensions
2. intensity modulated radiotherapy (IMRT): Defined as any treatment 
plan where intensity-modulated radiation beams and computerized inverse 
treatment planning is used
3. stereotactic body radiation therapy (SBRT): Defined as conformal RT 
(forward or reverse-planned) delivered in 3 to 5 relatively larger 
doses of ionizing radiation than typically delivered in a standard 
conformal schedule of 25-35 doses
4. proton beam radiotherapy (PBRT): Defined as any treatment plan where 
proton beam radiation is used

    Interventions may occur as part of a multimodal treatment strategy 
if the comparisons only differ with respect to the radiation therapy 
given.

Comparators

    All therapies will be compared to each other as part of a continuum 
of treatment for patients with head and neck cancer. Thus, we will 
include studies in which a RT method was compared to a different 
method, for example with or without chemotherapy or surgery. We will 
include all studies from which we can be reasonably certain additional 
treatments are contemporary and similar, leaving the major comparison 
that between RT modalities; those that we cannot ascertain from the 
publication will be excluded. To ensure chemotherapy or other 
treatments are similar and contemporary, we will consult accepted 
guidelines such as those from the National Comprehensive Cancer Network 
(NCCN) or National Cancer Institute (NCI). We will not extract details 
on chemotherapy dosages or schedules, but rather will ascertain their 
degree of general similarity and the proportions of patients who 
receive and complete such regimens. We will categorize and synthesize 
evidence according to overall treatment, for example concurrent 
chemoradiotherapy, or adjuvant radiotherapy, not mixing these in the 
strength of evidence synthesis.

Outcomes

    KQ 1, 3 & 4:
    1. Final outcomes: quality of life (QoL) and adverse events 
including; radiation induced toxicities, xerostomia, mucositis, taste 
changes, dental problems, and dysphagia.
    2. Intermediate outcomes: Salivary flow, probability of completing 
treatment according to protocol.
    We will search for evidence related to user experience, treatment 
planning, and target volume delineation within the context of KQ4. In 
the absence of an evidence-base on these measures, these issues will be 
addressed as appropriate in both the future research needs and 
discussion sections of the report.
    Based on input received from the TEP, any outcomes not adequately 
addressed in the literature will be stated as evidence gaps for primary 
research in the future research needs section of the report.
    KQ 2, 3 & 4:
    1. Final outcomes: Overall survival and cancer specific survival.
    2. Intermediate outcomes: Local control, and time to recurrence.

Timing

    All durations of follow-up will be considered.

Settings

    Inpatient and outpatient.

    Dated: March 6, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2014-05389 Filed 3-11-14; 8:45 am]
BILLING CODE 4160-90-P
```