Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Uterine Cervical Neoplasms

Pain

Head and Neck Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Antitussive Agents

Central Nervous System Depressants

Respiratory System Agents

Antipyretics

Anti-Obesity Agents

Vasoconstrictor Agents

Ketoprofen

Codeine

Acetaminophen

Analgesics, Non-Narcotic

Anti-Inflammatory Agents, Non-Steroidal

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Analgesics, Opioid

Narcotics

Phenylpropanolamine

Guaifenesin

Chlorpheniramine, phenylpropanolamine drug combination

Paracetamol 1 g IV then 1 g 3 times a day IV or oral (PO)

Paracetamol

Ketoprofen\* 100 mg (IV then PO) : Ketoprofen 100 mg IV 2 times a day or Ketoprofen LP 100 mg PO 2 times a day.

Danièle LEFEBVRE-KUNTZ, MD

Nathalie LEROUX-BROMBERG, MD

Danièle Lefebvre-Kuntz, MD

Nathalie Leroux-Bromberg, MD

Abesse Ahmeidi, MD

Agnès Hamdani, MD

Eliane Boufflers, MD

Eric Lartigau, MD

Bernard Coche-Dequeant, MD

Abel Cordoba, MD

Sophie Maillard, MD

Didier Delbrouck, MD

Nathalie LEROUX, MD

The results of the study will permit to set up a standardized and validated procedure of pain management authorizing medical and paramedical staff of brachytherapy department to handle pain and in this way to improve the quality of life of the patients.

* Selection criteria validation
* Patient information and collection of a signed informed consent
* Randomization
* Completion of HADS questionnaire
* Day 1 = Begin of analgesic treatment / brachytherapy
* T-30= 30 minutes before the operative procedure, IV administration of the analgesic treatment (Arm A or B) by the anesthetist
* T0= end of the operative procedure under general anesthesia
* T4, T8, and T12 = 4, 8 and 12 hours after T0: evaluation of pain level. If pain level ≥ 4:

  1. paracetamol-codeine (Arms A and B) and continuation of ketoprofen (Arm B). Then, if persistence of pain :
  2. paracetamol and morphine (Arms A and B)
* Day 2 to Day 30: At home or during hospital stay:

Pain assessment twice a day by the patient until absence of pain during 2 consecutive days

* Day 3 and Day 15: Pain assessment or phone interview by the algologist of the investigation center ; completion of a HADS questionnaire on Day 3
* Day 30= End of study: Pain assessment by the algologist of the investigation center and HADS questionnaire

In any case, pain assessment must be done until absence of pain during 2 consecutive days

Paracetamol With or Without Ketoprofen in the Management of Pain for Patients Receiving Brachytherapy (KETOCOL-1304)

Paracetamol With or Without Ketoprofen in the Management of Pain During Hospitalisation and at Home for Patients Receiving Brachytherapy: Phase-2 Randomized Study

Immediate post-operative pain will be assessed on a scale from 0 to 10. Experimental treatment will be considered as a success if the level of pain is \< 4, 4 hours after the surgical operation.

Assessment of the pain level at 8, 12 hours after the operative procedure, then twice a day during hospital stay or at home until the absence of pain during 2 consecutive days. This level will also be measured at days 3, 15 and 30 at hospital or during a phone interview (Days 3 and 15) and by the algologist of the investigation center on Day 30.

Santelys Association

Centre Oscar Lambret

A first series of questionnaires will be given by the investigator at patients before treatment (inclusion visit) and then the questionnaires will be given at the follow-up visits planned at 6 months, 12 months and 18 months.

Medical data will be collected via the CRF.

Questionnaires

Sophie FANTONI, Pr

Jean-Louis LEFEBVRE, Pr

The aim of this study is to explore the main factors associated with the return to work of patients presenting an upper aero-digestive tract cancer.

Socio-professional, medical, psychological, demographic, economic, and educational data collection in patients within the care pathway of upper aero-digestive tract cancer.

A series of questionnaires will be presented at the initial consultation and then at 6 months, at 12 months and at 18 months during follow-up visits. Medical data will be collected via the CRF.

Cancer of the Upper Aero-digestive Tract and Socio-professional Future

University Lille 3

Région Nord-Pas de Calais, France

University Hospital, Lille

Respiratory Tract (Lung and Bronchial) Diseases

Nervous System Diseases

Behaviors and Mental Disorders

Syndrome

Apnea

Sleep Apnea Syndromes

Sleep Apnea, Obstructive

Respiration Disorders

Respiratory Tract Diseases

Signs and Symptoms, Respiratory

Parasomnias

Sleep Disorders, Intrinsic

Dyssomnias

Sleep Wake Disorders

Sandrine Baron, MD

Prospective open-label, non-randomized, monocentric, cohort study, to assess the prevalence and severity of sleep apnea syndrome in patients treated for cancer of the upper aerodigestive tract.

The patient follows a usual course of care including, at the end of the treatment of his cancer of the upper aerodigestive tract, screening for obstructive sleep apnea syndrome at 3 months and 6 months (Epworth score and ventilatory polygraphy)

Prospective open-label, non-randomized, monocentric, cohort study, to assess the prevalence and severity of sleep apnea syndrome in patients treated for cancer of the upper aerodigestive tract.

Patients are included in the study when they are hospitalized for panendoscopy. Thereafter, it takes about 1 month to start any treatment. The duration of treatment is estimated at about 5 months (the longest regimen would be induction chemotherapy followed by surgery and adjuvant complementary treatment). After which the patient follows a usual course of care including, at the end of the treatment of his cancer of the upper aerodigestive tract, screening for obstructive sleep apnea syndrome at 3 months and 6 months (Epworth score and ventilatory polygraphy).

Obstructive Sleep Apnea Syndrome In Patients Treated For Cancer Of The Upper Aerodigestive Tract

Obstructive Sleep Apnea Syndrome In Patients Treated For Cancer Of The Upper Aerodigestive Tract : The SAOS-K Study

Obstructive sleep apnea syndrome is defined by an apnea-hypopnea index greater than or equal to 15 per hour

Delay in onset of obstructive sleep apnea syndrome after completion of cancer treatment

The Epworth auto-questionnaire, rated from 0 (better) to 24 (worse), assess day-time sleapiness.

Centre Hospitalier Sud Francilien

Lung Neoplasms

Behavior, Addictive

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Compulsive Behavior

Impulsive Behavior

Anti-Infective Agents

Ethanol

At the inclusion, a 45 min interview for : the completion of questionnaires (Fagerström, AUDIT, CAST, Socrates, M.I.N.I), the collection of socio-professional information, obstacles and incentives to stop the consumption of alcohol and tobacco, the record of alcohol-tobacco consumptions, the measurement of exhaled carbone monoxide rate expressed in particles per million using the CO tester.

At 3, 6, and 12 months : a 20 min interview to assess the alcohol-tobacco consumption and the obstacles and incentives to stop the consumption.

The first addiction consultation will be carried out directly in the cancer treatment unit and integrated to the overall cancer treatment program.

integrated addiction treatment program

The following actions will be performed by a nurse or by the study coordinator on site who have been trained in tobaccology and addictology :

* At the inclusion, a 45 minutes interview for : the completion of questionnaires (Fagerström, AUDIT, CAST, Socrates, M.I.N.I) , the collection of socio-professional information, obstacles and incentives to stop the consumption of alcohol and tobacco, the record of alcohol-tobacco consumptions, the measurement of exhaled carbone monoxide rate expressed in particles per million (ppm) using the CO tester.
* At 3, 6, and 12 months: a 20 minutes interview to assess the alcohol-tobacco consumption and the obstacles and incentives to stop the consumption

standard of care

Corinne Vannimenus, MD

This is a multicenter, interventional, randomized study among patients with a first lung or head \& neck cancer who are still active smokers ± alcohol misusers.The study will aim to compare the systematic implementation of an addiction treatment program initiated at hospital and integrated to the initial cancer treatment program (Arm A), versus the as-usual procedure, which consists in recommendations to follow an addiction treatment program (Arm B)

* Study proposal at the first medical consultation for therapeutic management of a first upper aerodigestive tract cancer or lung cancer.
* Selection criteria validation
* Collection of an informed consent
* Randomization :

Arm A: Experimental arm : Addiction consultation to the overall cancer treatment

Arm B: standard of care

The completion of questionnaires , the measurement of exhaled carbone monoxide rate using a CO tester for all patients, and the integrated addiction treatment among patients randomized in Arm A will not interfere with the medical treatment of cancer.

Alcohol and Tobacco Consumption in Patients With Head and Neck or Lung Cancer : Interest of an Addiction Treatment

Alcohol and Tobacco Consumption in Patients With Head and Neck or Lung Cancer : Interest of Integrating the Addiction Treatment to the Initial Cancer Treatment Program

to be a "tobacco abstinent" patient has to :

* be a smoker at the inclusion (M0)
* declare to be weaned at M6
* not declare a consumption between M6 and M12
* a CO rate less than 10 ppm measured with a CO test at M6 and M12

We compare the two arms in term of tobacco abstinent patients rate.

We considere the tobacco and alcohol consumption levels at T0, M3, M6, M12 by the consumption statement and the behaviour change towards tobacco and alcohol, thanks to questionnaires study specific.

to be a "tobacco abstinent" patient has to :

* be a smoker at the inclusion (M0)
* declare to be weaned at M6
* not declare a consumption between M6 and M12
* a CO rate less than 10 ppm measured with a CO test at M6 and M12

We calculate the percentage of tobacco abstinent patients at 12 months considering every patient in the trial.

We use a specialized monitoring in addictology (tobacco/alcohol) at 12 months according to the arms. The information of a monitoring in addictology will be obtained by the study specific questionnaire at M3, M6, M12

Time until progression. The time between the date of inclusion and the date of death whatever the cause is.

delay between inclusion date and progression date (clinical or radiological)

We note for each patient in arm A if they have at least one addictology specialized consultation after the first consultation which is imposed, during the 12 months

Centre Régional de Référence en Cancérologie

National Cancer Institute, France

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Oropharyngeal Neoplasms

Hypopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Hypopharyngeal Cancer

Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System

Head and Neck Surgery using the da Vinci® Robotic System

da Vinci® Robotic System

William Carroll, MD

To evaluate the use of the daVinci Robotic System for better visibility and access of head and neck lesions and decreased amount of surgery time.

This trial is a single institution non-randomized study to evaluate the efficacy and safety of the da Vinci® Robotic Surgical System. This study will evaluate the use of the daVinci Robotic System for better visibility and access of head and neck lesions and decreased amount of surgery time. This is a robotic system used by surgeons to perform surgery in a less invasive manner.

Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery

Number of participants with adequate exposure and access for use of the da Vinci® Robotic System in oropharyngeal and hypopharyngeal head and neck lesions

Assessment of patient safety evaluating the number of participants who experienced known complications from the use of the da Vinci® Robotic System during surgery, who experienced a need for conversion to open surgery during the procedure, or who required additional surgery for re-excision of the lesion due to positive margins

University of Alabama at Birmingham

Professor of Surgery

TORS Candidates

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

Number of participants with adequate exposure

Number of participants without adequate exposure

Number of Participants With Adequate Exposure and Access to Oropharyngeal and Hypopharyngeal Head and Neck Lesions

Known complication: oral hemorrhage

Known complication: injury to perioral structures

Known complication: airway edema

Known complication: nerve injury

Need for conversion to open procedure during surge

Need for re-exicision due to positive margins

Participants who successfully underwent transoral robotic-assisted surgery using the da Vinci® Robotic System

Assessment of Patients Safety by Evaluating the Number of Participants Who Experienced Known Complications From the Use of the da Vinci® Robotic System During Surgery, Experienced a Need for Conversion to Open Surgery or Required Additional Surgery.

Overall Study

Antineoplastic Agents

Amino Acids

Bevacizumab

Cisplatin

Endothelial Growth Factors

Mitogens

Erlotinib Hydrochloride

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Tyrosine

Radiation Therapy concurrent with cisplatin chemotherapy, Avastin and Tarceva

Chemoradiotherapy

Bevacizumab (Avastin) day 1 of weeks 1, 3, and 5 of radiation

Erlotinib

David M Brizel, MD

Radiotherapy (RT) with concurrent chemotherapy represents the state of the art in curative intent treatment for locally advanced squamous carcinoma of the head and neck. Tumor hypoxia and high levels of angiogenesis (blood vessel formation) are associated with treatment failure. Preclinical models reveal that radiotherapy itself may induce tumor secretion of vascular endothelial growth factor (VEGF). Curability may consequently be reduced by multiple mechanisms. Over-expression of epidermal growth factor receptor (EGFR) also occurs commonly and increases the risk of treatment failure. The addition of EGFR blockade to RT alone increases the chance of a cure. Concurrent VEGF and EGFR blockade could be synergistic with one another and improve the effectiveness of concurrent chemoradiation for advanced head and neck cancer.

This study will add angiogenic and epidermal growth factor receptor (EGFR) blockade into an established program of curative intent concurrent chemoradiation for locally advanced head and neck cancer. The safety and effectiveness of delivering the drugs bevacizumab and Tarceva in conjunction with twice daily irradiation and concurrent cisplatin (CDDP) chemotherapy will be determined.

Pre Radiation Period:

* Bevacizumab (10 mg/kg) on days -14 and 0, or
* Tarceva (100 mg) daily from -14-0, or
* Bevacizumab (10 mg/kg) on days -14 and 0; Tarceva (100 mg) daily from -14-0

Chemoradiation Period:

* Radiotherapy may be delivered via conventional 2-D, conformal 3-D, or intensity modulated (IMRT) technique as is clinically indicated. Radiotherapy and CDDP doses will be delivered uniformly to all treatment cohorts:

  * RT: 1.25 Gy BID M-F with a 6 hour interfraction interval
  * Treatment break during week 4. Total dose 70 Gy/7 weeks
  * CDDP: 33 mg/m2 M-W on weeks 1 and 5 of RT with standard DUMC hydration and anti-emetic regimens
* Bevacizumab (10mg/kg): Monday of weeks 1, 3, 5, 7 of RT
* Tarceva (100 mg): Daily for weeks 1-7 of treatment, except for days receiving CDDP

Safety Assessments:

* Baseline and then weekly assessments of blood pressure and urine protein : creatinine ratios during lead in and chemoRT phases of treatment
* Baseline carotid Doppler ultrasound evaluation
* Carotid Doppler ultrasound evaluation 1 month post-chemoRT

Efficacy Assessments:

* MR Imaging/Spectroscopy to be done at baseline, end of lead-in phase, end of week 1 of chemoRT, and end of chemoRT
* Angiogenic and EGFR related cytokines. Specifically, blood samples will be obtained to assay levels of VEGF, b-FGF, IL-8, D-dimer, EGF, TGF. These samples will be obtained on the same dates as the MR studies with an additional set of samples obtained at the midpoint of the lead in phase of treatment (day -7).

Clinical Assessments:

* All patients will undergo a minimum of once weekly interval history and physical examination including fiberoptic pharyngoscopy/laryngoscopy when indicated in the Department of Radiation Oncology to monitor for side effects and response to treatment as per standard routine for the care of patients with head and neck cancer.
* Patient compliance with Tarceva administration monitored via diary MRI/MRS (Magnetic Resonance Spectroscopy) DE-MRI

Angiogenic and EGFR Blockade With Curative Chemoradiation for Advanced Head and Neck Cancer

Concurrent Angiogenic and EGFR Blockade in Conjunction With Curative Intent Chemoradiation for Locally Advanced Head and Neck Cancer

Complete response (resolution) of tumor on clinical exam.

Genentech, Inc.

OSI Pharmaceuticals

David M. Brizel, MD

Professor, Radiation Oncology

Toxicity assessment weekly during treatment, and post treatment at 1 month and every 3 months through year 2.

Entire Study Population

Age Continuous

United States

Region of Enrollment

Feeding Tube Present Baseline

No Feeding Tube at Baseline

Feeding tube present before start of treatment

Feeding Tube

David Brizel, MD

2 participants had occult primaries, thus were not included in clinical complete response

Tumor Resolution

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Paracetamol With or Without Ketoprofen in the Management of Pain for Patients Receiving Brachytherapy (KETOCOL-1304)	NCT02439034	Uterine Cervica... Upper Aerodiges...	Paracetamol Ketoprofen	18 Years - 75 Years	Centre Oscar Lambret
Cancer of the Upper Aero-digestive Tract and Socio-professional Future	NCT01788878	Upper Aerodiges...	Questionnaires	18 Years - 55 Years	Centre Oscar Lambret
Obstructive Sleep Apnea Syndrome In Patients Treated For Cancer Of The Upper Aerodigestive Tract	NCT04262453	Upper Aerodiges... Obstructive Sle...		18 Years -	Centre Hospitalier Sud Francilien
Alcohol and Tobacco Consumption in Patients With Head and Neck or Lung Cancer : Interest of an Addiction Treatment	NCT02540174	Upper Aerodiges... Lung Cancer	integrated addi... standard of car...	18 Years - 65 Years	Centre Oscar Lambret
Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery	NCT00473564	Head and Neck C... Oropharyngeal C... Hypopharyngeal ... Upper Aerodiges...	da Vinci® Robot...	20 Years -	University of Alabama at Birmingham
Angiogenic and EGFR Blockade With Curative Chemoradiation for Advanced Head and Neck Cancer	NCT00140556	Head and Neck C... Pharynx Cancer	Chemoradiothera... Cisplatin Bevacizumab Erlotinib	18 Years -	Duke University
Analgesic Efficacy of Transmucosal Fentanyl for Breakthrough Pain Caused by Interventional Gastrostomy	NCT02869321	Gastrostomy Breakthrough Pa... Upper Aerodiges...	Fentanyl Morphine Sulfat... Fentanyl placeb... Morphine Sulfat... Gastrostomy	18 Years -	Central Hospital, Nancy, France

Spots Global Cancer Trial Database for upper aerodigestive tract neoplasms