Neoplasms

All Conditions

Mouth and Tooth Diseases

Digestive System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Xerostomia

Mucositis

Laryngeal Diseases

Laryngeal Cancer

Hypopharyngeal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Fluorouracil

Cisplatin

Lenograstim

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Adjuvants, Immunologic

Patients receiving chemotherapy and Low Dose (60 Gy) Radiation per protocol.

subcutaneously on Days 5-14, repeating every 3 weeks for 2 courses.

filgrastim

If applicable on day 5, repeating every 3 weeks for 2 courses.

pegfilgrastim

Intravenous over 1 hour on day 1, every 3 weeks for 3 courses.

cisplatin

docetaxel

fluorouracil

conventional surgery

60 Gy 5 days/week x 6 weeks with cisplatin

radiation therapy

Frank G. Ondrey, MD, PhD

RATIONALE: 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 or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with locally advanced head and neck cancer. The doctor also wants to find out if patients who receive this treatment need a feeding tube 1 year after starting treatment.

OBJECTIVES:

Primary

* Determine feeding tube dependency at 12 months in patients with locally advanced head and neck cancer treated with induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil followed by cisplatin and reduced-dose radiotherapy.

Secondary

* Determine the progression-free, disease-free, and overall survival of patients treated with this regimen.
* Determine the pattern of failure in patients treated with this regimen.
* Evaluate the quality of life of patients treated with this regimen.
* Assess pre- and post-treatment swallowing ability of patients and the impact on their quality of life.

Tertiary

* Quantify salivary flow rates of patients receiving chemotherapy with radiotherapy for head and neck malignancy.
* Evaluate the quality of saliva by examining total protein concentrations.
* Quantify proangiogenic cytokines (interleukin \[IL\]-1, IL-6, IL-8, and vascular endothelial growth factor) in the saliva of these patients.
* Determine the degree of mucositis and xerostomia of patients receiving chemotherapy with radiotherapy for head and neck malignancy.
* Compare salivary flow rates with the grade of mucositis and xerostomia of patients receiving chemotherapy with radiotherapy for head and neck malignancy.

OUTLINE: This is a pilot study.

* Induction therapy: Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1 followed by fluorouracil IV continuously on days 1- 4. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 5-14 or pegfilgrastim SC on day 5. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a partial or clinical complete response proceed to chemoradiotherapy 3 weeks later.
* Chemoradiotherapy: Patients receive cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo concurrent reduced-dose radiotherapy 5 days a week for 6 weeks.
* Surgery: Approximately 6 to 8 weeks after completing chemoradiotherapy, patients with residual neck disease or disease initially staged at N2 or greater undergo neck dissection.

Saliva is collected periodically to measure flow rates and quality; quantify proangiogenic cytokines (interleukin \[IL\]-1, IL-6, IL-8 and vascular endothelial growth factor); and examine the grade of mucositis and xerostomia.

Quality of life is assessed at baseline, before chemoradiotherapy, 1 month after the last radiation treatment, every 3 months for 1 year, and then every 6 months for 1 year.

After completion of study treatment, patients are followed periodically for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Combination Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer

Phase II Pilot Study of TPF (Docetaxel, Cisplatin, and 5-FU) Induction Chemotherapy Followed by Concurrent Cisplatin and Reduced Dose Radiation in Locally Advanced Head and Neck Cancer

All patients were non-evaluable and study was terminated early. There is no measure of outcome.

All patients were non-evaluable and study was terminated early. There is no measure of outcome. Utilizing RECIST criteria.

All patients were non-evaluable and study was terminated early. There is no measure of outcome. RECIST criteria measurement.

All patients were non-evaluable and study was terminated early. There is no measure of outcome. Measure using RECIST criteria.

All patients were non-evaluable and study was terminated early. There is no measure of outcome. Utilizing Swallowing Portion of ASHA Functional Communication Measure for Swallowing (FCM) and Dysphagia Outcome and Severity Scale (DOSS).

National Cancer Institute (NCI)

Masonic Cancer Center, University of Minnesota

Patients receiving combination chemotherapy plus low dose radiation

Chemotherapy + Low Dose Radiation

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

All 4 patients received high dose radiation (66-70 Gy). The radiation oncologist on this study deemed low dose radiation treatment was not appropriate for these patients. Therefore, the study participants are not evaluable.

Frank Ondrey, M.D.

All patients were non-evaluable - did not receive radiation dose per protocol.

Number of Patients With Feeding Tube Dependency

Number of Days With Progression-free Survival

Number of Days - Overall Survival

Number of Days With Disease Free Survival

Time to Treatment Failure

Swallowing Ability - Quality of Life Scores

Quality of Life (QOL) by Functional Assessment of Cancer Therapy-H&N QOL Questionnaire

Overall Study

Symptoms and General Pathology

Nasopharyngeal Carcinoma

Recurrence

Carcinoma, Basal Cell

Stomatitis

Carcinoma, Adenoid Cystic

Carcinoma, Verrucous

Carcinoma, Mucoepidermoid

Mucoepidermoid Tumor

Laryngeal Neoplasms

Oropharyngeal Neoplasms

Squamous Cell Carcinoma of Head and Neck

Salivary Gland Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Neoplasms, Squamous Cell

Respiratory Tract Diseases

Otorhinolaryngologic Diseases

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Otorhinolaryngologic Neoplasms

Respiratory Tract Neoplasms

Neoplasms, Basal Cell

Pharyngeal Neoplasms

Pharyngeal Diseases

Mouth Neoplasms

Salivary Gland Diseases

Nasopharyngeal Neoplasms

Nasopharyngeal Diseases

Adenocarcinoma

Neoplasms, Cystic, Mucinous, and Serous

Adenoid Cystic Carcinoma

Mucoepidermoid Carcinoma

Oral Cancer

Amino Acids

Lysine

Patients receive L-Lysine PO QD until completion of radiotherapy and resolution of mucositis in the absence of disease progression or unacceptable toxicity.

quality-of-life assessment

Discontinue supplement; treat symptomatically

management of therapy complications

L-lysine

Upendra Parvathaneni

This pilot clinical trial studies L-lysine in treating oral mucositis in patients undergoing radiation therapy with or without chemotherapy for head and neck cancer. L-lysine may lessen the severity of oral mucositis, or mouth sores in patients receiving radiation therapy with or without chemotherapy for head and neck cancer

PRIMARY OBJECTIVES:

I. To determine the complete response rate, decrease in severity, and time to complete response of oral mucositis related to head and neck cancer irradiation and chemotherapy after using L-lysine supplementation daily.

SECONDARY OBJECTIVES:

I. To determine the functional impact of use of L-lysine for oral mucositis on daily life as measured by the Functional Life Index-Cancer (FLIC) Questionnaire total score.

OUTLINE:

Patients receive L-lysine orally (PO) once daily (QD) until completion of radiotherapy and resolution of mucositis in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up weekly until mucositis resolves.

L-lysine in Treating Oral Mucositis in Patients Undergoing Radiation Therapy With or Without Chemotherapy For Head and Neck Cancer

L-lysine in the Treatment of Oral Mucositis in Head and Neck Cancer Patients- A Pilot Study

Complete Response will be documented by complete resolution of oral mucositis, as defined by the Radiation Therapy Oncology Group (RTOG) grading scale. If the true percent of patients that respond is 20%, we will have a 90% chance of seeing at least 1 patient in 10 with a response. If none of the 10 patients show significant improvement in time to response, then we can be 90% confident that the true rate of significant improvement is less than 20%.

University of Washington

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Combination Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer	NCT00352118	Head and Neck C...	filgrastim pegfilgrastim cisplatin docetaxel fluorouracil conventional su... radiation thera...	18 Years -	Masonic Cancer Center, University of Minnesota
L-lysine in Treating Oral Mucositis in Patients Undergoing Radiation Therapy With or Without Chemotherapy For Head and Neck Cancer	NCT01155609	Mucositis Oral Complicati... Oral Complicati... Recurrent Adeno... Recurrent Basal... Recurrent Lymph... Recurrent Lymph... Recurrent Mucoe... Recurrent Saliv... Recurrent Squam... Recurrent Squam... Recurrent Squam... Recurrent Squam... Recurrent Squam... Recurrent Verru... Recurrent Verru... Stage I Adenoid... Stage I Basal C... Stage I Lymphoe... Stage I Lymphoe... Stage I Mucoepi... Stage I Salivar... Stage I Squamou... Stage I Squamou... Stage I Squamou... Stage I Squamou... Stage I Squamou... Stage I Verruco... Stage I Verruco... Stage II Adenoi... Stage II Basal ... Stage II Lympho... Stage II Lympho... Stage II Mucoep... Stage II Saliva... Stage II Squamo... Stage II Squamo... Stage II Squamo... Stage II Squamo... Stage II Squamo... Stage II Verruc... Stage II Verruc... Stage III Adeno... Stage III Basal... Stage III Lymph... Stage III Lymph... Stage III Mucoe... Stage III Saliv... Stage III Squam... Stage III Squam... Stage III Squam... Stage III Squam... Stage III Squam... Stage III Verru... Stage III Verru... Stage IV Adenoi... Stage IV Basal ... Stage IV Lympho... Stage IV Lympho... Stage IV Mucoep... Stage IV Saliva... Stage IV Squamo... Stage IV Squamo... Stage IV Squamo... Stage IV Squamo... Stage IV Squamo... Stage IV Verruc... Stage IV Verruc...	quality-of-life... management of t... L-lysine	18 Years -	University of Washington

Spots Global Cancer Trial Database for oral complications of chemotherapy