[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced-head-and-neck-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced-head-and-neck-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,51,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100644619","integrated-early-care-for-head--neck-cancer-100644619",false,"NCT07671573","Integrated Early-CARE for Head & Neck Cancer.","Randomized Multicenter Clinical Trial of Early Integration of Palliative Care With Chemoradiotherapy Versus Chemoradiotherapy Alone in Patients With Locally Advanced Unresectable Head and Neck Cancer.","i-CARE-HN","Inclusion Criteria:\n\nEach patient must fulfil all of the following criteria:\n\n1. Diagnosis of locally advanced (unresectable) head and neck squamous cell carcinoma (HNSCC) of the oral cavity, oropharynx, larynx, and hypopharynx, staged according to the TNM AJCC 8th edition, proposed at a multidisciplinary team (MDT) meeting for definitive chemoradiotherapy (CRT) on an outpatient basis;\n2. Age ≥18 years;\n3. ECOG performance status 0-2;\n4. Adequate organ function: haemoglobin ≥9 g\u002FdL; neutrophils ≥1.5×10⁹\u002FL; platelets ≥100×10⁹\u002FL; creatinine ≤1.5×ULN; bilirubin, AST, ALT, LDH ≤1.5×ULN;\n5. Signed informed consent by the participant.\n\nExclusion Criteria:\n\nEach patient will be excluded if they meet any of the following criteria:\n\n1. ECOG performance status 3-4;\n2. Previous follow-up by specialised palliative care;\n3. Primary tumours of the nasopharynx, oesophagus, lip, or salivary glands;\n4. Metastatic head and neck cancer (oral cavity, oropharynx, larynx, and hypopharynx);\n5. Severe comorbidities: decompensated cardiovascular disease (NYHA class III\u002FIV heart failure, recent myocardial infarction), severe COPD (FEV₁ \\\u003C50% predicted), renal insufficiency (eGFR \\\u003C30 mL\u002Fmin), hepatic insufficiency (Child-Pugh B\u002FC);\n6. Laboratory values: neutrophils \\\u003C1.5×10⁹\u002FL, platelets \\\u003C100×10⁹\u002FL, haemoglobin \\\u003C9 g\u002FdL, creatinine \\>1.5×ULN;\n7. Diagnosis of dementia;\n8. Participation in another clinical trial.","ALL","18 Years",{"count":20,"type":21},64,"ESTIMATED","INTERVENTIONAL",[24],"NA","In Portugal, approximately 2,424 new cases of head and neck cancer are diagnosed each year, of which 60% are already at an advanced stage, presenting with intense pain and dysphagia (difficulty swallowing). There is also marked social isolation due to communication difficulties, economic hardship, and facial disfigurement (altered facial appearance). As a result, patients frequently face challenges in accessing specialised palliative care services, encountering delays, fragmentation, or a complete absence of such care.\n\nThe i-CARE-HN study is the solution: investigators aim to integrate outpatient palliative care with oncological treatment -namely chemoradiotherapy -at an earlier stage of the disease-when it is still limited to the throat and neck region, without metastasis (spread to other organs). This means multidisciplinary support from the outset of oncological treatment - symptom control, psychological support, and quality of life - without delaying the cure. It is like giving the patient a 'shield' against suffering, enabling them to complete treatment more efficiently.\n\nIn the i-CARE-HN study, early palliative care aims to better manage patients' symptoms (such as pain, difficulty speaking, swallowing, breathing, dry mouth, loss of appetite, and anxiety), to clarify doubts, to support therapeutic decisions, and to strengthen communication between the patient and the team, without replacing the primary oncological treatment. Rather than waiting for symptoms to worsen before seeking help, this support will be provided throughout treatment with chemotherapy and radiotherapy. Through this simultaneous integration of outpatient palliative care into oncological treatment, investigators hope to improve patients' symptoms and quality of life, as well as clinical outcomes: fewer treatment interruptions, improved treatment tolerability, fewer emergency hospitalisations, and greater overall survival. Investigators will want to know how patients are feeling throughout the process, and to that end, will invite them to complete a survey at several points during the study. Responses to the questionnaires are critical to enabling the medical team to rapidly identify which participating patients present with the most significant symptoms and the greatest risk of complications.\n\nThis study plans to recruit 64 patients aged 18 years or older, with a recent diagnosis of locally advanced, inoperable cancer, being followed on an outpatient basis at the IPO de Coimbra, IPO do Porto, and ULS de Coimbra, who will be invited to participate in the study. Should the patient agree to participate, some baseline data will be collected, and patients will subsequently be randomly assigned to one of two groups: one group will receive isolated chemoradiotherapy (standard treatment: cisplatin 100 mg\u002Fm² every 3 weeks- days 1, 22, and 49- and daily radiotherapy 70 Gy in 35 fractions over 7 weeks) and the other group will receive chemoradiotherapy alongside palliative care, on an outpatient basis (access to palliative care consultations). Patients randomised to the standard treatment group (chemoradiotherapy without a structured early palliative care intervention) will not have palliative care appointments systematically scheduled. However, should a referral to palliative care be requested, the patient may be directed to that clinical department.",[27,28,29],"Head & Neck Cancer","Locally Advanced Head and Neck Cancer","Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)",[31,32,33,34,35,36,37],"chemoradiotherapy","Cancer","Palliative care","Locally advanced Head and neck cancer","Squamous Cell Carcinoma of the Head and Neck","Edmonton Symptom Assessment System (ESAS)","Head and neck Squamous Cell Carcinoma","NOT_YET_RECRUITING","2026-06-25",{"date":41,"type":42},"2026-06-26","ACTUAL",{"date":44,"type":21},"2026-10-01",{"date":46,"type":21},"2028-03-31",{"name":48,"class":49},"Portuguese Oncology Institute, Coimbra","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100376780","carbon-ion-re-radiotherapy-in-patients-with-recurrent-or-progressive-locally-advanced-head-and-neck-cancer-100376780","NCT04185974","Carbon Ion Re-Radiotherapy in Patients With Recurrent or Progressive Locally Advanced Head-and-Neck Cancer","Carbon Ion Re-Radiotherapy in Patients With Recurrent or Progressive Locally Advanced Head-and-Neck Cancer: A Phase-II Study to Evaluate Toxicity and Efficacy","CARE","Inclusion Criteria:\n\n* Locally recurrent \u002F progressive head-and-neck cancer after initial radiation therapy\n* Microscopic or macroscopic tumor after salvage surgery\n* Indication for re-irradiation\n* Completed wound healing after surgical intervention\n* Karnofsky-Performance-Score ≥ 60\n* Age ≥ 18 years\n* Written informed consent (must be available before enrolment in the trial)\n* Ability of subject to understand character and individual consequences of the trial\n* For women with childbearing potential, (and men) adequate contraception\n* Submission of previous radiotherapy records\n\nExclusion Criteria:\n\n* Re-irradiation of malignancy in the larynx\n* Diagnosed plasmocytoma, sarcoma or chordoma\n* Previous re-irradiation in-field\n* Time interval \\\u003C 6 months after initial radiotherapy\n* Distant metastases (except pulmonary metastases)\n* Patients who have not recovered from acute toxicities of prior therapies\n* Refusal of the patients to take part in the study\n* Pregnant or lactating women\n* Known carcinoma \\\u003C5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy\n* Participation in another clinical study or observation period of competing trials, respectively",{"count":60,"type":21},72,[24],"After multimodal therapy of head-and-neck tumors, patients often develop local recurrence, locally progressive disease or second primary tumors. In this highly pre-treated patient cohort, therapeutic options are limited. Patients that are not candidates for salvage surgery may benefit from re-irradiation. Despite recent technical advances, re-irradiation is associated with severe side effects. Carbon ion Re-Radiotherapy (reCIRT) has shown encouraging results in retrospective analyses with moderate toxicity.\n\nIn the current Phase-II CARE-trial, reCIRT and conventional photon re-irradiation in patients with recurrent or progressive locally advanced head-and-neck cancer will be assessed regarding toxicity\u002F safety, local progression-free survival, overall survival and quality-of-life.",[64],"Locally Advanced Head-and-Neck Cancer","RECRUITING","2026-03-21",{"date":68,"type":42},"2026-03-25",{"date":70,"type":42},"2020-08-25",{"date":72,"type":21},"2031-01-30",{"name":74,"class":49},"University Hospital Heidelberg",2,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":87,"conditions":88,"keywords":93,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":75},"100588344","phase-2-toripalimab-with-chemotherapy-for-sinus-cancer-100588344","NCT06940180","Toripalimab With Chemotherapy for Sinus Cancer","Perioperative Chemoimmunotherapy With Toripalimab for Sinonasal Cancer","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed locoregionally advanced nasal cavity or paranasal sinus cancer including the following histologic subtypes: squamous cell carcinoma (SCC) of any morphologic variation: verrucous, papillary, basaloid, spindle cell, and adenosquamous; or sinonasal undifferentiated carcinoma (SNUC).\n* Participants with SCC should have resectable disease at baseline per the discretion of the treating surgical oncologist(s). \\*Participants with SNUC can have operable or borderline resectable (definition: resection would been morbid requiring extensive surgery and would have chances of incomplete gross total resection) disease as judged by the treating surgical oncologist(s).\n* Participants must have clinical stage disease as defined below using the 8th (2017) edition of the tumor, node, metastasis (TNM) staging system by the American Joint Committee on Cancer (AJCC) and the Union for International Cancer Control (UICC):\n\n  * T2, N1-3 III\n  * T3, any N III, IVA, IVB\n  * T4, any N IVA, IVB\n* Participants must be willing to provide blood and tissue pre-treatment and at the time of surgery for pathologic and correlative analyses.\n* Age 18 years or older at the time of informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count ≥1000\u002FmcL\n  * Platelets ≥100\n  * Total bilirubin ≤institutional upper limit of normal (ULN)\n  * AST(SGOT) \u002F ALT (SGPT) ≤3x ULN\n  * Creatinine ≤institutional ULN or GFR of ≥50 mL\u002Fmin\u002F1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL\u002Fmin\u002F1.73 m2\n* Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Contraception use should be maintained until at least 6 months after the last dose of chemotherapy for females and 3 months for males. In addition, contraception use should continue until 4 months after last dose of toripalimab for both males and females.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants with nasal cavity or paranasal sinus malignancies demonstrating histologies other than SCC or SNUC in the opinion of the reviewing pathologist. Excluded subtypes include: angiosarcomas, rhabdomyosarcomas, lymphomas, olfactory neuroblastomas (esthesioneuroblastomas), melanomas, and meningiomas among others. SNEC or sinonasal neuroendocrine carcinoma is not permitted.\n* Participants with unresectable or inoperable disease as judged by the treating surgical oncologist(s).\n* Participants with known distant metastatic disease (M1 or IVC).\n* Has received prior therapy with an anti-PD-1\u002FL1 agent or any other agent directed to another stimulatory or co-inhibitory T-cell receptor.\n* Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Non-live vaccines are permitted.\n* Carries a diagnosis of immunodeficiency or is receiving chronic systemic corticosteroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n* Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. Exceptions may be permitted at the discretion of the overall Sponsor-Investigator.\n* Has an active autoimmune disease that has required systemic treatment in past 6 months (with use of a disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is permitted.\n* Has a history of (non-infectious) pneumonitis or interstitial lung disease that required steroids or has current pneumonitis or interstitial lung disease.\n* Has a known history of human immunodeficiency virus (HIV) infection that is uncontrolled. No HIV testing is required unless mandated by local health authority. Patients with well controlled HIV may be eligible if their CD4 T cell count is favorable and their HIV viral load is undetectable.\n* Has a known history of active Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n* Has a history of allogeneic tissue or solid organ transplant.\n* Women who are pregnant or breastfeeding.",{"count":84,"type":21},20,[86],"PHASE2","The aim of this research study is to evaluate the effectiveness and safety of a combination of immunotherapy, using a drug called toripalimab, with chemotherapy drugs, Carboplatin and Docetaxel, as a possible treatment before surgery for sinonasal cancers.\n\nThe names of the study drugs used in this research study are:\n\n* Toripalimab (a type of monoclonal antibody)\n* Carboplatin (a type of antineoplastic agent)\n* Docetaxel (a type of antineoplastic agent)\n* Cisplatin (a type of antineoplastic agent)",[89,90,91,92,28],"Sinonasal Cancer","Paranasal Sinus Neoplasms","Squamous Cell Carcinoma","Sinonasal Undifferentiated Carcinoma",[94,91,92,28,95,96,89],"Paranasal Sinus Neoplasm","Advanced Sinonasal Cancer","Advanced Paranasal Sinus Cancer","2025-06-25",{"date":99,"type":42},"2025-06-26",{"date":101,"type":42},"2025-06-17",{"date":103,"type":21},"2029-02-01",{"name":105,"class":49},"Glenn J. Hanna"]