89 FR 167 pgs. 68904-68906 - Supplemental Evidence and Data Request on Medical Therapies for Locally Advanced Gastric Adenocarcinoma
Type: NOTICEVolume: 89Number: 167Pages: 68904 - 68906
Pages: 68904, 68905, 68906FR document: [FR Doc. 2024-19344 Filed 8-27-24; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Agency for Healthcare Research and Quality
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Medical Therapies for Locally Advanced Gastric Adenocarcinoma
AGENCY:
Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Request for Supplemental Evidence and Data Submission SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Medical Therapies for Locally Advanced Gastric Adenocarcinoma, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
DATES:
Submission Deadline on or before September 27, 2024.
ADDRESSES:
Email submissions: epc@ahrq.hhs.gov .
Print submissions:
Mailing Address: Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857
Shipping Address (FedEx, UPS, etc.): Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, MD 20857
FOR FURTHER INFORMATION CONTACT:
Kelly Carper, Telephone: 301-427-1656 or Email: epc@ahrq.hhs.gov .
SUPPLEMENTARY INFORMATION:
The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence for Medical Therapies for Locally Advanced Gastric Adenocarcinoma . AHRQ is conducting this review pursuant to Section 902 of the Public Health Service Act, 42 U.S.C. 299a.
The EPC 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 Medical Therapies for Locally Advanced Gastric Adenocarcinoma . The entire research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/gastric-cancers/protocol .
This is to notify the public that the EPC Program would find the following information on Medical Therapies for Locally Advanced Gastric Adenocarcinoma helpful:
A list of completed studies that your organization has sponsored for this topic. In the list, please 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, if relevant: 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 that your organization has sponsored for this topic . In the list, please provide the ClinicalTrials.gov trial number or, if the trial is not registered, the protocol for the study including, if relevant, 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 organization for this topic and an index outlining the relevant information in each submitted file.
Your contribution is very beneficial to the Program. Materials submitted must be publicly available or able to be made public. Materials that are considered confidential; marketing materials; study types not included in the review; or information on topics not included in the review cannot be used by the EPC 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 EPC Program website 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: https://effectivehealthcare.ahrq.gov/email-updates .
The review will answer the following questions. This information is provided as background. AHRQ is not requesting that the public provide answers to these questions.
Key Questions (KQ)
KQ1: What is the comparative effectiveness and comparative harms of medical therapies for management of non-metastatic, locally advanced gastric adenocarcinoma?
[top] KQ2: Do treatment effectiveness and harms vary by cancer stage, histology ( e.g. intestinal, diffuse, signet ring cell), biomarkers ( e.g. microsatellite instability-high [MSI-H] or mismatch repair-deficient [MMR-deficient], claudin, human epidermal growth factor receptor 2 [HER-2], programmed death-ligand 1 [PDL1], Epstein-Barr virus [EBV]), or genetic predisposition ( e.g. cadherin-1 [CDH1])?
KQ3: Do treatment effectiveness and harms vary by age, functional status ( e.g. Karnofsky score, Eastern Cooperative Oncology Group [ECOG] Performance Status score), medical comorbidities or conditions that increase risk of toxicity with specific therapy ( e.g. existing neuropathy, prior radiation therapy, history of autoimmune disease)?
| PICOTS | Inclusion | Exclusion |
|---|---|---|
| Population | All KQs: Adults (18 years or older) with primary, non-recurrent, non-metastatic locally advanced gastric adenocarcinoma stage T2N0 or higher KQ1: Subgroups of interest may include patients who previously received endoscopic therapy or surgery, patients who are non-surgical candidates, and patients with initially unresectable disease KQ2: Subgroups of interest may include patients with gastroesophageal junction (GEJ) cancer | Recurrent cancer, metastatic cancer, early stage (T1aN0 and T1bN0), stage 4 cancer, GEJ cancer patients treated in a predominantly esophageal cancer cohort with an esophageal treatment paradigm, gastrointestinal stromal tumors (GIST), neuroendocrine tumors, gastric lymphoma, MALToma, other rare gastric cancers. |
| Interventions | All KQs | |
| Cancer-directed medical therapies administered either alone or in any combination, and may be neoadjuvant, adjuvant, or perioperative (neoadjuvant and adjuvant) and in any sequence: • Chemotherapy including but not limited to: Fluoropyrimidine-based therapy: FOLFOX, XELOX, FLOT, SOX, ECF • Radiation including but not limited to external beam radiation, intra-operative electron radiation • Chemoradiation • HIPEC • Immunotherapy (e.g., ipilimumab, nivolimumab) • Targeted therapy (e.g., anti-HER2 monoclonal antibodies) | • Surgical management exclusively. • Intervention is not well specified (e.g., study reports intervention as "adjuvant chemotherapy" without describing the regimen). • Palliative interventions. | |
| Comparators | All KQs • Any comparator • No comparator (for biomarker-targeted interventions) | N/A. |
| Outcomes | All KQs • Overall survival • Progression-free survival • Nutritional assessment • Quality of life, using validated scales • Direct moderate-severe treatment adverse events (grade 3, 4, 5) • Direct mild treatment adverse events (grade 1, 2) • Indirect adverse events from treatment (e.g., long-term opioid use for pain management) | N/A. |
| Timing | All KQs: Any follow-up duration for grade 3-5 or indirect adverse events and quality of life; minimum of 1 year for grade 1-2 adverse events; minimum of 3 months for remaining outcomes | N/A. |
| Setting | All KQs: • Countries rated as very high on the 2024 Human Development Index (if study is multinational, at least one study center is in a country rated very high) | N/A. |
| Study Design and Other Criteria | All KQs: • Randomized controlled trials • Non-randomized studies of interventions (experimental or observational) with a concurrent comparator and well-controlled for confounding (at minimum account for age, stage, functional status, and comorbidities) • Single-arm studies (for biomarker-targeted interventions) • Published in English-language • Published in 2006 or later | Case reports, case series, commentaries, cross-sectional studies, reviews, qualitative studies. |
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Abbreviations: ECF = epirubicin, cisplatin, fluorouracil; FLOT = fluorouracil, leucovorin, oxaliplatin and docetaxel; FOLFOX = leucovorin, fluorouracil, and oxaliplatin; HER2 = human epidermal growth factor receptor 2; HIPEC = hyperthermic intraperitoneal chemotherapy; KQ = key question; SOX = tegafur, gimeracil, oteracil, and oxaliplatin; XELOX = capecitabine and oxaliplatin.
Marquita Cullom,
Associate Director.
[FR Doc. 2024-19344 Filed 8-27-24; 8:45 am]
BILLING CODE 4160-90-P