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Head and Neck Neoplasms clinical trials

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NCT ID: NCT06360978 Not yet recruiting - Clinical trials for Head and Neck Cancer

Efficacy and Toxicity of Docetaxel as a Radiosenstizer in Head and Neck Cancer

Start date: April 2024
Phase: Phase 2
Study type: Interventional

Head and neck cancer (HNC) is the seventh most common cancer globally, accounting for more than 660,000 new cases and 325,000 deaths annually. The overall incidence of HNC continues to rise, with a predicted 30% increase annually by 2030., this increase has been recorded across both developed and developing countries. Approximately 90% of HNCs are squamous cell carcinoma . The major risk factors of head and neck squamous cell carcinoma (HNSCC) are tobacco and heavy alcohol use and human papillomavirus infection . There has been a significant decline in smoking in high-income countries during the last few decades, which has led to a sharp decline in smoking related HNSCC . While increase in global incidence of human papillomavirus (HPV)-associated or positive (+) HNSCC Head and neck squamous cell carcinoma (HNSCC) is a highly challenging cancer, despite the advancements in treatment, the overall prognosis for HNSCC remains poor, with a five-year survival rate of around 50%. Chemoradiation is one of the treatment options for locally advanced head and neck cancers, the drug of choice for radiosensitization is cisplatin Although cisplatin-based chemoradiotherapy (CRT) is the standard of care for locally advanced head and neck squamous cell carcinoma (LAHNSCC), cisplatin is contraindicated in many patients because of age, diminished renal functions and hearing loss so docetaxel studied as an alternative radiosensitizer in this group. The addition of docetaxel to radiation improved DFS and OS in cisplatin-ineligible patients with LAHNSCC.

NCT ID: NCT06358053 Not yet recruiting - Cervical Cancer Clinical Trials

CRTE7A2-01 TCR-T Cells for HPV-16 Positive Advanced Cancers

Start date: April 15, 2024
Phase: Phase 1
Study type: Interventional

A single center, open, single arm dose escalation and dose expansion phase I study to evaluate the safety, tolerability, and efficacy of CRTE7A2-01 TCR-T cells in HLA-A*02:01+ Subjects HPV16 positive advanced cervical, anal, or head and neck cancers. The study will determine RP2D of CRTE7A2-01 TCR-T cell injection.

NCT ID: NCT06354712 Recruiting - Clinical trials for Oral Mucositis (Ulcerative) Due to Radiation

Efficacy of N-acetylcysteine in Preventing Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients.

Start date: April 4, 2024
Phase: Phase 2
Study type: Interventional

A prospective, randomized, controlled, parallel clinical trial will be conducted at Clinical Oncology and Nuclear Medicine Center at Mansoura University Hospital to assess the efficacy of N-acetylcysteine in the prevention of radiotherapy induced oral mucositis in Head and Neck cancer patients.

NCT ID: NCT06353685 Recruiting - Clinical trials for De-escalated Radiotherapy; Head and Neck Cancer

De-Escalation Postoperative Radiotherapy for Oral Squamous Cell Carcinoma With pCR/MPR.

Start date: May 1, 2024
Phase: Phase 2
Study type: Interventional

The prognosis of locally advanced oral squamous cell carcinoma(OSCC ) is poor, and there are still many problems to be solved in the current treatment paradigm. Neoadjuvant chemotherapy combined with immunotherapy can significantly improve the pCR and MPR rates in patients with locally advanced OSCC. For patients who achieve pCR and MPR after neoadjuvant therapy and surgery, it is still hotly debated regarding whether to implement postoperative de-escalation radiotherapy. Neoadjuvant therapy is an ideal predictor of radiosensitivity. In theory, neoadjuvant therapy can eliminate microscopic lesions, thereby reducing the dose and volume of irradiation. Continuous hyperfractionated accelerated radiotherapy (CHART, based on hyperfractionated radiotherapy, increasing daily or weekly treatments and shortening the total treatment duration, but reducing the total dose), is to give a higher dose of radiation to tumor tissue in a shorter period of time, so as to overcome the accelerated reproliferation and inhibit the repair of sublethal damage of tumor cells. It is beneficial to improve the local control rate of tumor, control the acute injury of normal tissue and the yield acceptable late treatment-related complications. The specific protocol was as follows: high-risk CTV area (CTV1), 45Gy in total, fraction dose of 1.5Gy, twice a day, bioequivalent dose (BED) of 51.75Gy; Low-risk CTV area(CTV2), 39Gy in total , fraction dose of 1.3Gy, twice a day, BED of 44.07Gy; A total of 30 radiotherapy fraction were performed 10 times a week for 3 weeks.

NCT ID: NCT06347185 Not yet recruiting - Clinical trials for Head and Neck Neoplasms

Simultaneous Care in Recurrent and/or Metastatic Head and Neck Cancer: the SupCare Study

SupCare
Start date: September 2024
Phase: N/A
Study type: Interventional

This is a late phase II, prospective, multicenter randomized study, to assess the value of early palliative care integrated with the standard oncologic care in patients with Recurrent Metastatic (RM) Head and Neck Cancer (HNC) proposed to first line palliative systemic treatment. The study randomizes patients in a 1:1 fashion to standard oncologic care, in which the palliative care is requested as needed (reactive approach) or to early palliative care integrated with the standard oncologic care (proactive approach). Standard of Care: the oncologist will be the main referral of the patient, deciding the therapeutic approach, the assessments requested, in terms of type of exams and timing and the need of possible further support from other expertise. The oncologist will base the choices also upon the results of the Liverpool Head and Neck Patient Concern Inventory (PCI-H&N) and the patient's preferences. At the end of the first oncological visit, the physician will be asked to predict the survival of the patient. Integrated approach: Besides the Oncology visit, patient will have the palliative care expert visit and follow up. The oncologist will define the therapeutic approach and the assessments requested, in terms of type of exams and timing. The palliative care clinician and the oncologist will judge the burden of symptoms and together they will propose the suggested interventions to relief the symptoms, with a particular attention to a validated instrument (the PCI-H&N) and patient priority questionnaire's results. Stratification Factors - Institution - Performance Status (PS) (0 vs 1-2) - Presence of any caregiver at home - Type of treatment (Immunotherapy alone vs any other combination) Study duration: the total study duration is estimated at 36 months, with a total accrual time estimated to be 24 months from first patient in (FPI) and with an additional follow-up period of 12 months. End of study occurs when all patients have completed their end of study visit and the study is mature for all analyses defined in the protocol and the database has been cleaned and frozen for these analyses.

NCT ID: NCT06345287 Recruiting - Clinical trials for Head and Neck Cancer

Response Adaptive Radiotherapy Following Immunotherapy-based Induction for Non-HPV Related HNSCC

Start date: January 1, 2024
Phase: Phase 2
Study type: Interventional

The aim of this study is to develop an adaptive radiation therapy plan for locally advanced head and neck squamous cell carcinoma receiving induction therapy containing immunotherapy and chemotherapy. The therapy plan is based on clinical remission, in order to reduce treatment-related toxic side effects without sacrificing clinical efficacy and improve the quality of life of patients.

NCT ID: NCT06344208 Recruiting - Clinical trials for Head and Neck Cancer

Predicting Toxicity in Elderly Patients With Head and Neck Cancer

PREtoxEL
Start date: March 15, 2022
Phase:
Study type: Observational

Predicting toxicity in elderly patients with head and neck cancer: validating a disease-oriented toxicity predictive tool and integrating it with avail-able screening tools for better outcomes.

NCT ID: NCT06341985 Recruiting - Clinical trials for Head and Neck Cancer

DOsimetry and Radiation Induced NAusea in Head and Neck Cancers

DORIAN
Start date: November 15, 2021
Phase:
Study type: Observational

This is a prospective cohort study for the analysis of correlation between dosimetric parameters and RANV (Radiation Associated Nausea and Vomiting) in patients with head and neck cancer undergoing exclusive radiotherapy (RT). The primary purpose of this study is to search for a potential correlation between dosimetry and physician- and patient-rated symptoms in patients treated with exclusive radiotherapy for head and neck cancer.

NCT ID: NCT06338657 Recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

FID-007 Followed by Standard of Care Surgery in Head and Neck Cancer

Start date: April 1, 2024
Phase: Phase 1
Study type: Interventional

This phase I trial studies on how the PEOX-based polymer encapsulated paclitaxel FID-007 (FID-007) affects the immune cells around the tumor patients with head and neck squamous cell carcinoma. The active drug in FID-007 is paclitaxel, an established chemotherapy drug that has been shown to kill cancer cells. FID-007 is a packaged form of paclitaxel using a polyethylozaxoline (PEOX) polymer which may allow the drug to reach deeper into tumors and less into normal cells by being smaller. This study is being done to help identify future treatment options and better understand how to improve outcomes of patients with head and neck cancers after surgery.

NCT ID: NCT06335342 Recruiting - Clinical trials for Head and Neck Neoplasms

Radiotherapy Treatments for Neoplasms in the Head and Neck Region

Start date: February 22, 2018
Phase:
Study type: Observational

The aim of this study is the evaluation of clinical and dosimetric aspects, tolerance, and effectiveness of radiotherapy treatments in the head and neck region. Eligible patients undergoing radiotherapy for primary or secondary neoplasms localized in the head and neck anatomical region.