Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Musculoskeletal Diseases

Rare Diseases

Carcinoma

Maxillary Sinus Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Paranasal Sinus Neoplasms

Nose Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nose Diseases

Respiratory Tract Diseases

Paranasal Sinus Diseases

Respiratory Tract Neoplasms

Otorhinolaryngologic Diseases

Sinonasal Undifferentiated Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Cisplatin

Immunomodulating Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

patients will receive pembrolizumab 200 mg + cisplatin 75mg/mq and docetetaxel 75 mg/mq every three weeks (Q3W) for 3 courses, followed by standard of care

Pembrolizumab administration in combination with chemotherapy for 3 cycles, followed by standard of care

Viola Ghio, M.Sc.

Laura D Locati, MD, PhD

This study will test the Safety and activity of pembrolizumab plus chemotherapy as neoadjuvant treatment in locally advanced sinonasal undifferentiated carcinoma (SNUC).

Activity of neoadjuvant chemotherapy in locally advanced SNUC has been already demonstrated; the primary hypothesis is that the addition of pembrolizumab as neoadjuvant and adjuvant agent might confirm the results obtained with a combined treatment strategy including chemotherapy, decreasing the burden of treatment-related side effects.

Pembrolizumab in Locally Advanced Sinonasal Carcinoma

Neoadjuvant Pembrolizumab Plus Chemotherapy in Locally Advanced Sinonasal Carcinoma

ORR defined as the sum of complete remission (CRs) and partial responses (PRs) by RECIST v. 1.1

Merck Sharp & Dohme LLC

Istituti Clinici Scientifici Maugeri SpA

Skin and Connective Tissue Diseases

Mouth and Tooth Diseases

Nervous System Diseases

Carcinoma, Squamous Cell

Melanoma

Salivary Gland Neoplasms

Carcinoma, Adenoid Cystic

Esthesioneuroblastoma, Olfactory

Carcinoma, Mucoepidermoid

Mucoepidermoid Tumor

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Adenocarcinoma

Neoplasms, Cystic, Mucinous, and Serous

Neuroblastoma

Neuroectodermal Tumors, Primitive, Peripheral

Neoplasms, Neuroepithelial

Olfactory Nerve Diseases

Cranial Nerve Diseases

Adenoid Cystic Carcinoma

Olfactory Neuroblastoma

Myoepithelial Carcinoma

Mucoepidermoid Carcinoma

Neuroepithelioma

Subjects treated at Massachusetts General Hospital with proton beam therapy

Intensity-modulated radiation therapy at institutions other than Massachusetts General Hospital

Proton radiation therapy

Intensity-modulated radiotherapy

Annie W Chan, MD

The purpose of this study is to test the hypothesis that 1)intensity-modulated radiotherapy (IMRT) or proton radiation therapy would result in improved local control rate and lowered toxicity compared to conventional radiotherapy, and 2) proton radiation therapy would result in equivalent or improved local control rate with similar or lower toxicity compared to IMRT, in the treatment of locally advanced sinonasal malignancy.

Data from retrospective studies suggest that IMRT or proton radiation therapy resulted in promising outcome in patients with sinonasal malignancy. To this date, no prospective study has been conducted to evaluate the outcome of sinonasal cancer treated with IMRT or proton radiation therapy. This Phase II trial is the first prospective study conducted to determine the treatment outcome and toxicity of IMRT or proton in the treatment of sinonasal cancer.

IMRT and proton radiation therapy are the two most established and most commonly employed advanced radiotherapy techniques for the treatment of sinonasal cancer. It is highly controversial whether one is superior to the other in terms of local control and toxicity outcome. It is also not clear if a subset of patients would benefit more from one treatment technology versus the other.

Due to the rarity and heterogeneity of sinonasal malignancies and the fact that proton beam is only available at a few centers in the United States, it is not feasible at present to do a Phase III study randomizing patients between IMRT and proton radiation therapy. In this study, a planned secondary analysis will be performed, comparing the treatment and toxicity outcome between IMRT and proton. The data on the IMRT and proton comparison from this trial will be used to design future multi-center prospective trials and to determine if randomized trial is necessary.

In this study, the treatment technique employed for an individual case will not be determined by the treating physician(s), but rather by the most advanced technology available at the treating institution for the treatment of the sinonasal cancer. At the Massachusetts General Hospital (MGH), proton beam therapy will be used for patients who meet the eligibility criteria. For institutions where protons are not available or institutions where the proton planning systems have not been optimized, IMRT exclusively will be used for the treatment of sinonasal cancer. Patient and tumor characteristics are expected to be comparable between IMRT- and proton- institutions

Subjects will receive daily proton radiation treatment as outpatients at the Francis H. Burr Proton Center at Massachusetts General Hospital. The subjects may also receive concurrent standard chemotherapy every week during their radiation therapy. This chemotherapy is considered standard treatment for their cancer and is not being done for research purposes.

In addition to daily radiation treatments, subjects will have the following tests every week: review of side effects; physical exam, including weight, height, neurological exam and vital signs; and blood tests, only for those subjects also receiving chemotherapy.

Subjects will be followed for 5 years after the completion of study treatment. The first follow-up visit will be 6-8 weeks after completion of study treatment. Additional follow-up visits will be performed every 3 months during the first 2 years following completion of radiation then every 6 month during years 3-5. At each follow-up visit, subjects will receive a physical exam, chest CT scan (at 1st follow-up visit then at least every 6 months), a CT or MRI tumor assessment (at 1st follow-up visit then at least every 6 months), quality-of-life questionnaire, hearing test, neuro-ophthalmology test, and neurocognitive test.

Intensity-Modulated or Proton Radiation Therapy for Sinonasal Malignancy

A Phase II Study of Intensity-Modulated or Proton Radiation Therapy for Locally Advanced Sinonasal Malignancy

To determine the local control rates with IMRT or proton radiation therapy at 2 years.

To determine the late visual-orbital late effects of IMRT or proton beam

To determine the regional control at 2 years after IMRT or proton

To determine the long-term survival at 5 years after IMRT or proton

To assess quality-of-life (QOL) outcomes after IMRT or proton

To determine the patterns of tumor relapse after IMRT or proton

To determine long-term local control after IMRT or proton

To determine long-term neurocognitive function after IMRT or proton

National Institutes of Health (NIH)

National Cancer Institute (NCI)

Massachusetts General Hospital

Assistant Professor

Neoplasms, Squamous Cell

Sinus Cancer

Carboplatin

Docetaxel

Fluorouracil

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

INDUCTION CHEMOTHERAPY: Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 30-180 minutes or carboplatin IV on day 1, and fluorouracil IV continuously on days 1-4. Cycles repeat every 3 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity.

Patients who achieve CR or PR receive 1 additional course of treatment and undergo chemoradiotherapy over 6-7 weeks. Patients who have SD or PD to induction therapy, or less than a complete response to chemoradiotherapy undergo surgery and radiation therapy.

Chemoradiotherapy

Definitive Surgical Resection

Quality-of-Life Assessment

Radiation Therapy

Ehab Y Hanna

This phase II trial studies how well docetaxel, cisplatin and fluorouracil work in treating patients with previously untreated stage II-IV nasal cavity and/or paranasal sinus cancer. Drugs used in chemotherapy, such as docetaxel, cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

PRIMARY OBJECTIVES:

I. To determine the clinical/radiographic complete and partial response rate after induction chemotherapy with docetaxel, cisplatin and fluorouracil (TPF).

II. To improve local tumor control to 80% at 2 years.

SECONDARY OBJECTIVES I. Disease specific-survival and overall survival rates. II. Organ preservation (orbital, maxillary, cranial) rate. III. Patterns of treatment failure (local, regional, and distant). IV. Acute and late treatment-related toxicity. V. The effect of treatment on Quality of Life with and without surgery (i.e., M. D. Anderson Symptom Inventory \[MDASI\], M. D. Anderson Dysphagia Inventory \[MDADI\], Xerostomia Questionnaire, Performance Status Scale for Head \& Neck Cancer Patients \[PSS-HN\], etc.).

VI. To evaluate the effects of induction chemotherapy on biological markers that could serve as surrogates for response and predictors of long-term outcome.

OUTLINE:

INDUCTION CHEMOTHERAPY: Patients receive docetaxel intravenously (IV) over 1 hour on day 1, cisplatin IV over 30-180 minutes or carboplatin IV on day 1, and fluorouracil IV continuously on days 1-4. Cycles repeat every 3 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity.

Patients who achieve complete response (CR) or partial response (PR) receive 1 additional course of treatment and undergo chemoradiotherapy over 6-7 weeks. Patients who have stable disease (SD) or progressive disease (PD) to induction therapy, or less than a complete response to chemoradiotherapy undergo surgery and radiation therapy.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 4 months for 1 year and every 6 months for 2 years.

Docetaxel, Cisplatin and Fluorouracil in Treating Patients With Previously Untreated Stage II-IV Nasal Cavity and Paranasal Sinus Cancer

Phase II Trial of Induction Therapy With Docetaxel, Cisplatin and Fluorouracil in Previously Untreated Patients With Locally Advanced Squamous Cell Carcinoma and/or Poorly Differentiated Carcinoma of the Nasal Cavity and/or Paranasal Sinuses

M.D. Anderson Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pembrolizumab in Locally Advanced Sinonasal Carcinoma	NCT05925491	Sinonasal Undif...	Pembrolizumab	18 Years -	Istituti Clinici Scientifici Maugeri SpA
Intensity-Modulated or Proton Radiation Therapy for Sinonasal Malignancy	NCT01586767	Adenoid Cystic ... Squamous Cell C... Sinonasal Carci... Sinonasal Undif... Mucoepidermoid ... Schneiderian Ca... Myoepithelial C... Esthesioneurobl... Melanoma	Proton radiatio... Intensity-modul...	18 Years -	Massachusetts General Hospital
Docetaxel, Cisplatin and Fluorouracil in Treating Patients With Previously Untreated Stage II-IV Nasal Cavity and Paranasal Sinus Cancer	NCT00707473	Locally Advance... Nasal Cavity an... Sinonasal Undif... Stage II Nasal ... Stage III Nasal... Stage IVA Nasal... Stage IVB Nasal...	Carboplatin Chemoradiothera... Cisplatin Definitive Surg... Docetaxel Fluorouracil Quality-of-Life... Radiation Thera...	17 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for sinonasal undifferentiated carcinoma