Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Anti-Allergic Agents

Central Nervous System Depressants

Dermatologic Agents

Antisickling Agents

Paclitaxel

Carboplatin

Dexamethasone

Fluorouracil

Albumin-Bound Paclitaxel

Cisplatin

Nivolumab

Dexamethasone acetate

Mitogens

Diphenhydramine

Promethazine

Famotidine

Hydroxyurea

Tubulin Modulators

Antimitotic Agents

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Enzyme Inhibitors

Hypnotics and Sedatives

Anesthetics

Anesthetics, Local

Histamine H1 Antagonists

Histamine

Histamine phosphate

Histamine Antagonists

Neurotransmitter Agents

Antacids

Anti-Ulcer Agents

Histamine H2 Antagonists

All enrolled patients will receive three 21-day cycles of chemotherapy consisting of nab-paclitaxel (100 mg/m2 on days 1, 8, 15; 9 doses total), carboplatin (AUC 5 on day 1; 3 doses total), and nivolumab (360 mg on days 1; 3 doses total). Growth factor support will be provided using G-CSF administered on days 16-18.

Adjuvant nivolumab will be offered to all patients for 6-months post completion of locoregional therapy.

Following the induction treatments (carboplatin, nab-paclitaxel, and nivolumab), patients will be assessed based on response to chemotherapy and high or low risk status.

Patients with low risk and small volume tonsillar disease (T1-T2, non-bulky N2A-N2B with ≤2 non-lower neck lymph nodes measuring ≤5 cm in size) or base of tongue disease (T1-2 with lateralized primary ≤3 cm, non-bulky N2A-N2B with ≤2 non-lower neck lymph nodes measuring ≤5 cm in size) who have ≥50% reduction by RECIST following induction chemotherapy will undergo TORS and selective nodal dissection. De-intensified adjuvant RT will be given for adverse pathologic features. Patients may refuse TORS treatment.

Patients with low risk, who do not qualify for TORS (due to volume of disease or poor visualization/access) or refuse TORS, who have ≥50% reduction by RECIST following induction chemotherapy will be given de-intensified treatment with radiation alone to 50 G.

Following the induction treatments (carboplatin, nab-paclitaxel, and nivolumab), patients will be assessed based on response to chemotherapy and high or low risk status.

Patients who have low risk disease with \<50% but ≥30% reduction of tumor by RECIST with induction chemotherapy will receive CRT to 50 Gy with concurrent bolus cisplatin (x2 doses) or TFHX (paclitaxel, 5-FU, hydroxyurea, dexamethasone, famotidine, and diphenhydramine) to 45 Gy (3 cycles).

Patients who have high risk disease and ≥50% reduction of tumor by RECIST with induction chemotherapy will receive CRT to 50 Gy with concurrent bolus cisplatin (x2 doses) or TFHX to 45 Gy (3 cycles).

Following the induction treatments (carboplatin, nab-paclitaxel, and nivolumab), patients will be assessed based on response to chemotherapy and high or low risk status.

Patients who have low risk disease and \<30% reduction of tumor by RECIST with induction chemotherapy will receive CRT to 70 Gy with concurrent bolus cisplatin (x3 doses) or TFHX (paclitaxel, 5-FU, hydroxyurea, dexamethasone, famotidine, and diphenhydramine) to 75 Gy (5 cycles).

Patients who have high risk disease and \<50% reduction of tumor by RECIST with induction chemotherapy will receive CRT to 70 Gy with concurrent bolus cisplatin (x3 doses) or TFHX to 75 Gy (5 cycles).

Any patient who has progressive disease will receive CRT to 70 Gy with concurrent bolus cisplatin (x3 doses) or TFHX to 75 Gy (5 cycles).

All enrolled patients will receive three 21-day cycles of nab-paclitaxel (100 mg/m2 on days 1, 8, 15; 9 doses total)

nab-paclitaxel

All enrolled patients will receive three 21-day cycles of carboplatin (AUC 6 on day 1; 3 doses total).

All enrolled patients will receive three 21-day cycles of nivolumab (360 mg on days 1; 3 doses total).

Adjuvant nivolumab will be offered to all patients for 6-months post completion of locoregional therapy for a total of 7 doses.

Cisplatin will be given on an every 3 weeks basis at a dose of 100 mg/m2 IV over 3-4 hrs day 1 (or 2) and 22 (or 23). Only for patients on the Intermediate Dose Arm and additionally on day 43 (or 44) for patients on the Regular Dose Arm.

Patients on the Intermediate or Regular Dose Arms will receive chemoradiation for 3-5 cycles (6-10 weeks). On day 0 patients will start hydroxyurea at 500 mg PO q 12 hours x 6 days (11 doses). The first daily dose of hydroxyurea on days 1 - 5 is given 2 hours prior to the first fraction of daily radiotherapy.

Patients on the Intermediate or Regular Dose Arms will receive chemoradiation for 3-5 cycles (6-10 weeks). On day 0 at 1800 patients will start continuous infusion of 5-FU at 600 mg/m2/day x 5 days (120 hours).

5-FU

Patients on the Intermediate or Regular Dose Arms will receive chemoradiation for 3-5 cycles (6-10 weeks). On days 1-5 patients will receive dexamethasone 20 mg PO (IV) in am Day 1, 1 hr prior to paclitaxel

Patients on the Intermediate or Regular Dose Arms will receive chemoradiation for 3-5 cycles (6-10 weeks). On days 1-5 patients will receive famotidine 20 mg PO (IV) in am Day 1, 1 hr prior to paclitaxel.

Patients on the Intermediate or Regular Dose Arms will receive chemoradiation for 3-5 cycles (6-10 weeks). On days 1-5 patients will receive diphenhydramine 50 mg PO (IV) in am Day 1, 30 mins prior to paclitaxel.

Patients on the Intermediate or Regular Dose Arms will receive chemoradiation for 3-5 cycles (6-10 weeks). On days 1-5 patients will start paclitaxel 100 mg/m2 after first RT fraction on day 1 of each cycle. Paclitaxel should be administered in 250 ml 0.9% NaCl over 60 minutes.

Patients with low risk and small volume tonsillar disease (T1-T2, non-bulky N2A-N2B with ≤2 non-lower neck lymph nodes measuring ≤5 cm in size) or base of tongue disease (T1-2 with lateralized primary ≤3 cm, non-bulky N2A-N2B with ≤2 non-lower neck lymph nodes measuring ≤5 cm in size) who have ≥50% reduction by RECIST following induction chemotherapy will undergo TORS and selective nodal dissection. Patients may refuse TORS treatment. Patients will receive RT or TORS.

Transoral robotic surgery (TORS)

Patients with low risk, who do not qualify for TORS (due to volume of disease or poor visualization/access) or refuse TORS, who have ≥50% reduction by RECIST following induction chemotherapy will be given de-intensified treatment with radiation alone to 50 Gy. Patients will receive RT or TORS.

Adjuvant RT

Patients who have low risk disease with \<50% but ≥30% reduction, or patients who have high risk disease and ≥50% reduction of tumor by RECIST with induction chemotherapy will receive CRT to 50 Gy with concurrent bolus cisplatin (x2 doses) or TFHX to 45 Gy (3 cycles).

Patients who have low risk disease and \<30% reduction of tumor, patients who have high risk disease and \<50% reduction of tumor by RECIST, or any patient who has progressive disease with induction chemotherapy will receive CRT to 70 Gy with concurrent bolus cisplatin (x3 doses) or TFHX to 75 Gy (5 cycles).

Chemoradiotherapy

Everett Vokes, MD

Carboplatin, nab-paclitaxel, and nivolumab combination will be administered for three cycles of three weeks duration each. TORS or RT/CRT will be performed after induction chemotherapy (i.e. day 64 of therapy). Patients with low risk and small volume tonsillar disease (T1-T2, non-bulky N2A-N2B with ≤2 non-lower neck lymph nodes measuring ≤5 cm in size) or base of tongue disease (T1-2 with lateralized primary ≤3 cm, non-bulky N2A-N2B with ≤2 non-lower neck lymph nodes measuring ≤5 cm in size) who have ≥50% reduction by RECIST following induction chemotherapy will undergo TORS and selective nodal dissection. De-intensified adjuvant RT will be given for adverse pathologic features. Patients may refuse TORS treatment.

Patients with low risk, who do not qualify for TORS (due to volume of disease or poor visualization/access) or refuse TORS, who have ≥50% reduction by RECIST following induction chemotherapy will be given de-intensified treatment with radiation alone to 50 Gy.

Before induction chemotherapy, patients will undergo examination under anesthesia and direct laryngoscopy to tattoo and photograph the primary tumor to plan the post-induction resection. Adjuvant nivolumab will be offered to all patients for 6-months post completion of definitive therapy (7 doses given as a flat dose of 480mg, every four weeks).

A phase II trial in human papillomavirus (HPV)-positive oropharyngeal squamous cell cancer (as determined by p16 immunohistochemistry with confirmatory ISH or PCR) to determine radiologic response to induction chemotherapy with nivolumab. Patients will undergo evaluation by a multidisciplinary team prior to risk assessment. The patients will be assigned to high or low risk groups based on tumor size, lymph node involvement, and smoking history. Patients will be assigned to treatment with induction chemotherapy with carboplatin, nab-paclitaxel, and nivolumab. Radiologic response to induction chemotherapy according to RECIST measurement of tumor shrinkage will then be used for therapeutic stratification of locoregional therapy, consisting of either transoral robotic surgery (TORS) or radiation with or without chemotherapy. Patients with low risk disease (see table above) and small volume tonsillar/BOT disease (T1-2 primary, non-bulky N2A-N2B nodal status) who have ≥50% reduction by RECIST following induction chemotherapy will undergo TORS for primary site resection and selective nodal dissection as a definitive treatment if technically feasible with adjuvant radiation for adverse pathologic features. Patients with other low risk tumors e.g. with higher volume disease, or who refuse surgery, who also have ≥50% reduction by RECIST following induction chemotherapy will be given de-intensified treatment with radiation alone to 50 Gy (no chemotherapy). Patients with low risk features and \<50% but ≥30% reduction OR high risk features (T4, bulky N2B or N2C-N3, \>10 pack-years tobacco use) with ≥50% reduction will receive de-intensified chemoradiation with concurrent cisplatin-RT to 50 Gy (5 weeks) or TFHX to 45 Gy (3 cycles/6 weeks). Patients with low risk features and \<30% reduction OR high risk disease with \<50% reduction or any patients with progressive disease during induction chemotherapy will undergo chemoradiotherapy with concurrent cisplatin-RT to 70 Gy (7 weeks) or TFHX to 75 Gy (5 cycles/10 weeks). Patients with both high and low risk features who have ≥50% reduction will receive locoregional therapy targeting the pre-chemotherapy extent of disease only. Adjuvant nivolumab will be offered to all patients for 6-months post completion of definitive therapy (7 doses given as a flat dose of 480mg, every four weeks).

Chemotherapy and Locoregional Therapy Trial (Surgery or Radiation) for Patients With Head and Neck Cancer

A Phase II Trial of Nivolumab/Nab-paclitaxel/Carboplatin Induction Chemotherapy Followed by Response-stratified Locoregional Therapy for Patients With Locoregionally Advanced HPV-related Oropharyngeal Cancer- the OPTIMA II Trial

DRR is defined as ≥50% tumor shrinkage by RECIST 1.1. We will evaluate the overall percentage of patients treated with dose-reduced radiotherapy or TORS to determine the tumor shrinkage based on treatment received.

All recorded adverse events will be listed and tabulated by system organ class, preferred term and treatment. Vital signs and clinical laboratory test results will be listed and summarized by treatment. Any significant physical examination findings, and clinical laboratory results will be listed. ECG readings will be evaluated by the investigator and abnormalities, if present, will be listed.

Time to locoregional and distant failure rates will be estimated by the Kaplan-Meier methodology and comparisons will be made using the log-rank test.

University of Chicago

Behaviors and Mental Disorders

Quality of Life

Patients operated by Trans-oral Robotic Surgery (TORS)

Patients operated by Trans-oral Laser Microsurgery (TLM)

Patients treated by Intensity Modulated Radiation Therapy (IMRT)

* Arm 1: Intensity-Modulated Radiation Therapy (IMRT)
* Arm 2: Trans-oral Laser Microsurgery (TLM)
* Arm 3: Trans-oral Robotic Surgery (TORS)

TORS

Hassid Samantha, Doctor

Hassid Dr Samantha, Doctor

In this project, the investigators will realize an observational, prospective, multicentric and international clinical trial, to objectively compare patients with SSCC according to 3 arms of treatment:

* Arm 1: Radiotherapy ± chemotherapy
* Arm 2: Trans-oral Laser Microsurgery (TLM)
* Arm 3: Trans-oral Robotic Surgery (TORS)

The main goal is to evaluate the efficacy of each treatment with four classes of outcomes:

* The quality of life (QoL) before and after each treatment option, using validated questionnaires
* Oncological outcomes
* Functional outcomes
* Economical Resources

The population will include cT1-T2 /cN0-N1/M0 supraglottic squamous cell carcinoma.

The primary outcome is a Clinical Dysphagia QoL evaluation assessed by the MD Anderson Dysphagia questionnaire. Secondary outcomes include others QoL evaluation, oncological and functional measures and cost parameters. The sample size needs to reach 36 patients per arm (total 108).

Treatment of Early Supraglottic Squamous Cell Carcinoma With Advance Technologies

Treatment of Supraglottic Squamous Cell Carcinoma With Advance Technologies: Observational Evaluation of Quality of Life, Oncological Outcomes, Functional Outcomes and Economical Resources

Clinical Dysphagia QoL evaluation after treatment will be assessed using MD Anderson Dysphagia Index (MDADI). MDADI consists of 20 items pooled in 4 subscales: the global scale (1 item); the functional scale (5 items); the physical scale (8 items); and the emotional scale (6 items). All items are scored on a 5-point scale (1-5), where "1" corresponds to "total agreement" and "5" to "total disagreement." All except 2 items were scored such that higher scores indicated higher functioning. Responses on all domains were summed to calculate the total score (MDADI-T). The maximum score is 100, indicating high functioning, and the minimum score is 20, indicating poor functioning.

QoL will be evaluated with the validated European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire It is composed on five functional scales (physical, performance, cognitive, emotional and social), three symptoms scale (fatigue, pain, nausea and vomiting), a global health status/QoL scale and 6 simple items for assessment of symptoms or additional problems (dyspnea, loss of appetite, insomnia, financial difficulties, constipation and diarrhea). All of the scale and single item measures range in score from 0 to 100. Regarding functional and overall health status scales, higher scores relate to better quality of life; however, for the scales of symptoms, higher scores correspond to the higher presence of this symptom and, consequently, the worse quality of life.

QoL will be evaluated with the validated European Organization for Research and Treatment of Cancer (EORTC) H\&N43 questionnaire It comprises 43 questions about symptoms and side effects of treatment, social function, body image and sexuality. It incorporates 12 symptom scales (pain, swallowing, problems with teeth, dry month and sticky saliva, problems with senses, speech, body image, social eating, sexuality, problems with shoulder, skin problems and fear of progression) and 7 simple items (problems opening mouth, coughing, social contact, swelling in the neck, weight loss, problem with wound healing and neurological problems). All of the scales and the single item measures range in score from 0 to 100. A high score represents a high level of symptomatology or problems.

Swallowing function by FEES evaluation (Fiberoptic Endoscopic Evaluation of Swallowing) objectively evaluated by the Penetration-aspiration Scale (PAS) The PAS is an 8-point scale that rates the degree of airway invasion. Score of 1 is normal, score between 2-5 represent laryngeal penetration and scores up to 6 indicate airway aspiration.

CTC-AE Score for early and late complication The Common Terminology Criteria for Adverse Events (CTC-AE) is a descriptive terminology which was published by the National Cancer Institute (NCI) as part of an ongoing effort to standardize adverse events (AE) reporting within oncology. AE are graded according to an ordinal scale where 1 represents asymptomatic or mild symptoms and 5 represents death from the AE. In between, 2 is moderate, 3 is severe, and 4 is life-threatening. E.g., with regard to dysphagia, the CTCAE uses the descriptive terminology listed in Table 1, columns 1 and 2. CTCAE dysphagia grades are based on symptoms, diet, and tube dependency. This scale will be filled in by the physician.

Naso-gastric Feeding tube and/or gastrostomy use (duration in days)

Need of hospitalization (yes or no; if yes, duration in days)

Centre Hospitalier Universitaire UCLouvain Namur

Professor

All patients underwent primary tumour resection with transoral robotic surgery (TORS) using the daVinci robot (Intuitive Surgical, Sunnyvale CA)

Transoral robotic surgery is an option to treat supraglottic squamous cell carcinomas. Oncological outcomes 2 years after transoral robotic surgery for supraglottic laryngectomy were studied.

Local Control After Robot-assisted Supraglottic Laryngectomy

Evaluation of Local Control 2 Years After Robot-assisted Supraglottic Laryngectomy: a Multicenter Retrospective Study

Proportion of patients without cancer recurrence 2 years after surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Chemotherapy and Locoregional Therapy Trial (Surgery or Radiation) for Patients With Head and Neck Cancer	NCT03107182	HPV-Related Squ... HNSCC	nab-paclitaxel Carboplatin Nivolumab Cisplatin Hydroxyurea 5-FU Dexamethasone Famotidine Diphenhydramine Paclitaxel Transoral robot... Adjuvant RT Chemoradiothera...	18 Years -	University of Chicago
Treatment of Early Supraglottic Squamous Cell Carcinoma With Advance Technologies	NCT05611515	Supraglottic Sq... Early Stage (T1...	TORS	18 Years -	Centre Hospitalier Universitaire UCLouvain Namur
Local Control After Robot-assisted Supraglottic Laryngectomy	NCT03357107	Supraglottic Sq...	Transoral robot...	18 Years -	Hospices Civils de Lyon

Spots Global Cancer Trial Database for transoral robotic surgery (tors)