Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Chemo-immunotherapy with Senolytics: Docetaxel @ 75 mg per square meter, administered as a 1-hour intravenous infusion in normal saline over 1 hour (day 1)
CDDP @ 75 mg per square metr
Sponsors
AIIMS, New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1 - Age 18 to 65 years 2 - Histologically confirmed squamous cell carcinoma of the oral cavity 3 - Patients with BROCC as per the below-mentioned criteria - meeting minimum one Buccal mucosa primary, with diffuse margins and peritumoral soft tissue going up to or above the level of the zygomatic arch and without any satellite nodules. Buccal mucosa primary, with type II involvement of the masticator space - medial pterygoid muscle, lateral pterygoid muscle, lower half of the pterygoid plates and temporalis muscle. Tongue primary- anterior two-thirds with the tumor extending up to or below the level of the hyoid bone. Extension of tumor of the anterior two-thirds of the tongue to the vallecula, as this would again necessitate a total glossectomy. Extension of primary into the high infratemporal fossa, as defined by the extension of the tumor above an axial plane passing at the level of the sigmoid notch. Extensive skin infiltration impacting the achievement of negative margins. 4 -ECOG PS 0-1 5 - Meeting the following standard values of general laboratory tests completed within 7 days prior to randomization and values are within the parameters required by the protocol WBC count more than 4,000/uL, hemoglobin more than 8 g/L, platelet count more than 100,000/uL ALT and AST less than 2.5 times the upper limit of normal Total Bilirubin less than 1.5 times the upper limit of normal Serum creatinine less than 1.5 times the upper limit of normal 6 - Written informed consent.
Exclusion criteria
Exclusion criteria: 1- Cervical node encasing carotids greater than 180 degrees 2- Class III masticator space involvement 3- Loco-regionally extensive carcinoma tongue, wherein, resection would entail sacrifice of bilateral lingual neurovascular pedicle or a total glossectomy 4- Carcinoma tongue with deep infiltration involving geniohyoid and tumour infiltration extending till the hyoid/ pre-epiglottic space/ larynx 5- Carcinoma buccal mucosa or gingiva-buccal sulcus causing skin infiltration in the form multiple subdermal metastasis 6- Cervical node with direct skin involvement 7- Distant metastasis 8- Have undergone surgery involving primary tumor or lymph nodes -except diagnostic biopsy 9- Have received any prior radiotherapy or chemotherapy 10- Have had other malignancies within 5 years 11- Have creatinine clearance less than 60 mL/min. 12- Cisplatin ineligible patients 13- Unstable angina within 3 weeks or with a history of myocardial infarction within last 6 months 14- Pregnant or breastfeeding females or those not willing for contraception. 15- Any N3b nodal involvement. 16- Node or tumour encasing vessel or nerve.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the surgical conversion rates after NAT between the study arms.Timepoint: End of Surgery End of Study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1- Proportion of patients undergoing ORR in each arm via RECIST 1.1 criteria. Timepoint: Within 4 weeks of last cycle of chemotherapy End of Study;2- Proportion of patients with PCR in each arm.Timepoint: End of Surgery End of Study;3- Proportion of patients with MPR in each arm.Timepoint: End of Surgery End of Study;4 - Response correlation with CPS in each arm.Timepoint: End of Surgery End of Study;5- Median DFS in each arm.Timepoint: End of Study;6- Median OS in each arm.Timepoint: End of Study;7- To evaluate QoL of patients in each arm.Timepoint: Within 7 days prior to day 1 of cycle 1 Within 3 days prior to day 1 of further cycles Within 4 weeks of last cycle of chemotherapy End of Study ;8- Adverse Events in each arm as per CTCAE 5.0Timepoint: Within 3 days prior to day 1 of further cycles Within 4 weeks of last cycle of chemotherapy;9- To evaluate the benefit of revised surgical margin in each arm.Timepoint: End of Surgery End of Study | — |
Countries
India
Contacts
Public ContactDR AKASH KUMAR
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed