Neoplasms

All Conditions

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Carcinoma

Carcinoma, Squamous Cell

Recurrence

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Laryngeal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Antimetabolites

3,000 mg/m2 IV over 30 minutes on days 1 and 15 (q28 days).

gemcitabine

150 mg/m2 IV over 1 hour on days 1 and 15 (q 28 day cycle), administered after gemcitabine

paclitaxel

Omer Kucuk, MD

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine together with paclitaxel may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with paclitaxel works in treating patients with persistent, recurrent, or metastatic head and neck cancer.

OBJECTIVES:

* Determine overall and progression-free survival probability in patients with persistent, recurrent, or metastatic squamous cell carcinoma of the head and neck treated with gemcitabine and paclitaxel.
* Determine the confirmed and unconfirmed response (partial and complete) probability in patients with measurable disease treated with this regimen.
* Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.

Patients are followed every 8 weeks until disease progression, every 6 month for 2 years, and then annually for 1 year.

PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 10-13 months.

S0329, Gemcitabine and Paclitaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer

A Phase II Study of Biweekly Gemcitabine and Paclitaxel (GEMTAX) Combination in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Measured from time of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

Measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.

Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other normal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.

Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.

National Cancer Institute (NCI)

SWOG Cancer Research Network

Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.

Gemcitabine and Paclitaxel

Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR. Eligible patients who received any treatment were included in baseline measures.

Age Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Lip/Oral Cavity

Nasopharynx

Oropharynx

Salivary glands

Hypopharynx

Larynx

Paranasal Sinuses

Other/Unknown

Primary Site

Newly Diagnosed

Persistent

Recurrent

Not Reported

Disease Status

Performance status is graded according to the Zubrod Performance Status Scale. Patients with a performance status of 0 are fully active, able to carry on all pre-disease performance without restriction. Patients with a performance status of 1 are restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work.

Performance Status

Study Statistician

All eligible patients who started treatment were included in this measure.

Progression-free Survival

Overall Survival

Complete Response

Partial Response

Unconfirmed Complete Response

Unconfirmed Partial Response

Stable/No Response

Increasing Disease

Assessment Inadequate

All eligible patients with measurable disease who started treatment were included in response measures.

Response

Allergic reaction/hypersensitivity

Anorexia

Dehydration

Diarrhea

Dyspnea (shortness of breath)

Fatigue (asthenia, lethargy, malaise)

Febrile neutropenia

Glucose, serum-high (hyperglycemia)

Hemoglobin

Hemorrhage, pulmonary/upper respiratory - Nose

Hypotension

Inf (clin/microbio) w/Gr 3-4 neuts - Lung

Inf w/normal ANC or Gr 1-2 neutrophils - Catheter

Inf w/normal ANC or Gr 1-2 neutrophils - Lung

Leukocytes (total WBC)

Lymphopenia

Memory impairment

Mucositis/stomatitis (functional/symp) - Oral cav

Muscle weakness, not d/t neuropathy - body/general

Neuropathy: motor

Neuropathy: sensory

Neutrophils/granulocytes (ANC/AGC)

Pain - Bone

Pain-Other (Specify)

Platelets

Pneumonitis/pulmonary infiltrates

Rash/desquamation

Rash: acne/acneiform

Sodium, serum-low (hyponatremia)

Thrombosis/thrombus/embolism

Vomiting

Eligible patients who received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.

Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug

Overall Study

Musculoskeletal Diseases

Paranasal Sinus Neoplasms

Nose Neoplasms

Otorhinolaryngologic Neoplasms

Nose Diseases

Respiratory Tract Diseases

Paranasal Sinus Diseases

Respiratory Tract Neoplasms

Otorhinolaryngologic Diseases

All of the tests, procedures and treatments may be considered standard of care for someone with this type of cancer, except for the Xerostomia Questionnaire.

Xerostomia questionnaire

Roi Dagan, MD, MS

The purpose of this study is to collect information from a questionnaire and medical records to see what effects proton radiation has on cancer and collect and analyze morbidity outcomes: incidence of Xerostomia (dry mouth) and tumor control.

The study is non interventional outcomes protocol designed to collect information from a questionnaire and medical records to see what effects proton radiation has on cancer and collect and analyze morbidity outcomes: incidence of Xerostomia (dry mouth) and tumor control.

Photon/Proton Radiation Therapy for Cancers of the Nasal Cavity and/or Paranasal Sinuses

A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Cancers of the Nasal Cavity and/or Paranasal Sinuses

University of Florida

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Cisplatin

Alkylating Agents

Stereotactic Body Radiation Therapy (SBRT) and Cisplatin. Starting Dose: 6 Gy/ Fraction 5/ Total 30 Gy/ Cisplatin 15 mg/m\^2

Cisplatin 15 mg/m\^2 prior to each fraction

All participants will be treated every other day (excluding Saturday/Sunday). Starting Dose: 6 Gy/ Fraction 5/ Total 30 Gy.

Stereotactic Body Radiation Therapy (SBRT)

Jimmy Caudell, M.D., Ph.D.

This study involves another course of radiation (called re-irradiation) to the participant's tumor. The type of radiation is called stereotactic body radiation therapy (SBRT). The purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT given along with the chemotherapy drug, cisplatin. The researchers want to see which dose of radiation will work best in controlling the growth of head/neck cancer. The usual treatment for head/neck cancer that has grown is surgery and/or more radiation with various chemotherapy drugs.

Stereotactic Body Radiation Therapy (SBRT) is a relatively new radiation technique in which a few very high doses of radiation are delivered to small, well-defined tumors. It has been used effectively in other cancers like lung and liver. The goal is to deliver a radiation dose that is high enough to kill the cancer while limiting radiation to surrounding healthy organs. The daily dose of radiation is 2-3 times greater than conventional radiotherapy, but it is given for only 5 days over a 2 week period. Conventional radiotherapy is given over 6-7 weeks. The chemotherapy drug, cisplatin is used as a radiation sensitizer and will be given before each of the 5 radiation treatments.

Stereotactic Body Radiotherapy and Concurrent Cisplatin for Re-Irradiation of Unresectable, Recurrent Squamous Cell Carcinomas of Head and Neck

A Phase I Dose Escalation Trial of Stereotactic Body Radiotherapy and Concurrent Cisplatin for Re-Irradiation of Unresectable, Recurrent Squamous Cell Carcinomas of the Head and Neck

The traditional 3+3 dose escalation method will be utilized for this phase I study, with up to 3 sequential cohorts. The maximal tolerated dose (MTD) of Stereotactic Body Radiation Therapy (SBRT) radiation dose associated with a ≤ 33% probability of dose-limiting toxicity (DLT). DLT is defined as any grade 4 or greater toxicity, per The Common Terminology Criteria for Adverse Events v4 (CTCAE v4) that occurs within 3 months from the start of SBRT.

Local control is defined as lack of progression as defined radiographically or pathologically proven within the SBRT treated area. This will be calculated via Kaplan-Meier method. Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) \[Eur J Ca 45:228-247, 2009\]. Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.

Overall survival will be calculated from the end of SBRT treatment to time of death or last contact via Kaplan-Meier method.

H. Lee Moffitt Cancer Center and Research Institute

Skin and Connective Tissue Diseases

Mouth and Tooth Diseases

Nervous System Diseases

Rare Diseases

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

Sinonasal Undifferentiated 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)

Massachusetts General Hospital

Assistant Professor

(8 x 3 GyE) carbon ion therapy followed by 50 Gy IMRT (2 Gy/ Fx)corresponding to a total dose of approximately 74 GyE.

8 fractions carbon ion (8 x 3 GyE C12) therapy followed by 25 fractions of IMRT corresponding to a total dose of approximately 74 GyE. Treatment duration is approximately 61/2-7 weeks

carbon ion boost

Juergen Debus, MD PhD

The IMRT-HIT-SNT trial is a prospective, mono-centric, phase II trial evaluating toxicity and efficacy in the combined treatment with intensity-modulated radiation therapy (IMRT) and carbon ion (C12) boost. Primary endpoint is mucositis ≥ CTC°3, secondary endpoints are local control, disease-free survival, overall survival, and toxicity. Planned accrual of the trial includes 36 patients with histologically proven (≥R1-resected or inoperable) sinonasal malignancies.

Local control in sinonasal malignancies is dose dependent. However, dose escalation at acceptable toxicity is technically demanding even with modern radiotherapy techniques. Raster-scanned carbon ion therapy with highly conformal dose distributions may allow higher doses at comparable or reduced side-effects.

Methods/ design:

The IMRT-HIT-SNT trial is a prospective, mono-centric, phase II trial evaluating toxicity in the combined treatment with intensity-modulated radiation therapy (IMRT) and carbon ion (C12) boost in 36 patients with histologically proven (≥R1-resected or inoperable) adeno-/ or squamous cell carcinoma of the nasal cavity or paransal sinuses. Patients receive 24 GyE carbon ions (8 fractions) and IMRT (2.0 Gy/ fraction).

Study objectives:

Incidence of mucositis ≥ CTC°3 will be assessed as the primary endpoint of the trial, local control, disease-free survival, overall survival, and toxicity (incl. mucositis CTC °I-II and late toxicity at 2 years post RT)are secondary endpoints.

Treatment of Malignant Sinonasal Tumours With Intensity-modulated Radiotherapy (IMRT) and Carbon Ion Boost (C12)

Incidence of mucositis ≥ CTC°III will be assessed as the primary endpoint of the trial at completion of radiation therapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
S0329, Gemcitabine and Paclitaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer	NCT00100789	Head and Neck C...	gemcitabine paclitaxel	18 Years -	SWOG Cancer Research Network
Photon/Proton Radiation Therapy for Cancers of the Nasal Cavity and/or Paranasal Sinuses	NCT00797498	Cancers of Nasa... Cancers of Para...	Xerostomia ques...	18 Years -	University of Florida
Stereotactic Body Radiotherapy and Concurrent Cisplatin for Re-Irradiation of Unresectable, Recurrent Squamous Cell Carcinomas of Head and Neck	NCT02158234	Squamous Cell C...	Cisplatin Stereotactic Bo...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Stereotactic Body Radiotherapy and Concurrent Cisplatin for Re-Irradiation of Unresectable, Recurrent Squamous Cell Carcinomas of Head and Neck	NCT02158234	Squamous Cell C...	Cisplatin Stereotactic Bo...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
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
Treatment of Malignant Sinonasal Tumours With Intensity-modulated Radiotherapy (IMRT) and Carbon Ion Boost (C12)	NCT01220752	Sinonasal Malig... Adenocarcinoma ...	carbon ion boos...	18 Years - 80 Years	Heidelberg University
A Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib) in Patients With Advanced Solid Tumors Harboring PTCH1 Loss of Function Mutations	NCT05199584	Solid Tumors Wi...	ENV-101 (talade...	18 Years -	Endeavor Biomedicines, Inc.
S0329, Gemcitabine and Paclitaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer	NCT00100789	Head and Neck C...	gemcitabine paclitaxel	18 Years -	SWOG Cancer Research Network

Spots Global Cancer Trial Database for nasal cavity

Every month we try and update this database with for nasal cavity cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.