Phase I study to assess the safety of hyperthermic intracavitary chemotherapy in advanced oral cavity cancer - HICOC

Tata Memorial Centre0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月29日

试验速览

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•1.Ability to understand the procedure and willingness to sign an informed consent
•2.ECOG Performance Status 2
•3.Age 18 years old, up to 65 years old
•4.Histopathology proven diagnosis of squamous cell carcinoma
•5.Surgically resectable Stage III/IV oral cancer, as per the multidisciplinary discussion
•6.Primary tumor should be lateralised so as to not require bilateral neck dissection
•7.Nodal disease with/without extranodal extension on clinical examination/imaging
•8.No distant metastases below the clavicles, based upon the following minimum diagnostic workup:
•a.History/physical examination by the physician
•b.Imaging of the head and neck (Contrast enhanced MRI for local workup and Chest CT/PET-CT for distant metastatic workup)
•9.Fit for major surgery, American Society of Anesthesiologists ASA 1/2
•10.Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 to 2
•11.Adequate organ function
•12.Patients with no contraindications to Cisplatin chemotherapy and radiotherapy
•13.Women of child bearing age should not be pregnant at the time of enrolment and should be willing to use adequate contraception during the treatment phase

•1.History of allergic reactions to compounds of similar chemical or biologic composition to cisplatin, carboplatin, and paclitaxel
•2.Prior invasive malignancy, unless disease free for a minimum of 3 years, with the exception of radically excised basal cell
•3.Prior chemotherapy for a different cancer administered within 3 years prior to registration
•4.Prior radiotherapy to the region of the head and neck that would result in overlap of radiation therapy fields
•5.Unresectable primary or nodal disease involving the carotid vessels, prevertebral fascia or skull base
•6.Calculated GFR less 50 cc/min
•7.Patients who have uncontrolled cardiac comorbidity
•8.Presence of previous episode of thrombosis or embolism or presence of a prothrombotic condition in last 1 year
•9.Presence of severe malnutrition
•10.Severe active co-morbidities
•11.Radiographic evidence of retropharyngeal and or level VI metastasis
•12.Patients on other investigational drugs within last 30 days

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