study of combination of Radiation treatment and chemotherapy in advanced Cancer of Head & Neck.

Conditions

Health Condition 1: null- Patients of Advanced stage Head and Neck carcinoma. having Squamous cell carcinoma.

Vijay Patil, Vanita Noronha, Nandini Menon, Minit Shah, Sarbani Laskar Ghosh et al. (12 authors)

Journal of Clinical Oncology2024-06-05

10.1200/jco.2024.42.17_suppl.lba6092

Prognostic and predictive roles of cancer stem cell markers in head and neck squamous cell carcinoma patients receiving chemoradiotherapy with or without nimotuzumab.

Patel U, Kannan S, Rane SU, Mittal N, Gera P, Patil A, Manna S, Shejwal V, Noronha V, Joshi A, Patil VM, Prabhash K, Mahimkar MB.

2022-02-097 citations

10.1038/s41416-022-01730-9

Prognostic and predictive significance of nuclear HIF1α expression in locally advanced HNSCC patients treated with chemoradiation with or without nimotuzumab

Usha Patel, Manish Pandey, Sadhana Kannan, Tanuja A. Samant, Poonam Gera et al. (13 authors)

British Journal of Cancer2020-09-1720 citations

10.1038/s41416-020-01064-4

Optimal cumulative cisplatin dose for radio-sensitization in locally advanced head and neck cancer.

Atanu Bhattacharjee, Vanita Noronha, Vijay Patil, Anuja Abhayankar, Amit Joshi et al. (7 authors)

Journal of Clinical Oncology2020-05-204 citations

10.1200/jco.2020.38.15_suppl.e18553

Prognostic value of radiological extranodal extension detected by computed tomography for predicting outcomes in head and neck squamous cell cancer patients treated with radical chemoradiotherapy.

Abhishek Mahajan, Ankur Chand, Vijay Patil, Vanita Noronha, Amit Joshi et al. (19 authors)

Journal of Clinical Oncology2020-05-201 citations

10.1200/jco.2020.38.15_suppl.6560

Results of a randomized phase III study of nimotuzumab in combination with concurrent radiotherapy and cisplatin versus radiotherapy and cisplatin alone, in locally advanced squamous cell carcinoma of the head and neck.

Vijay Patil, Vanita Noronha, Amit Joshi, Jaiprakash Agarwal, Sarbani Ghosh Laskar et al. (20 authors)

Journal of Clinical Oncology2018-05-2011 citations

10.1200/jco.2018.36.15_suppl.6000

Interventions

Intervention1: Chemo Radiation and Nimotuzumab: It is standard of care and cisplatin + Radiotherapy regimen. BIOMAb-EGFRÂ® (Nimotuzumab) will be administered irrespective of any delay or modification

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed Squamous Cell Carcinoma of Head and Neck in advanced stage [stage III or IVA ,B)] considered to be suitable for concurrent chemoradiotherapy. 2. Written informed consent has been obtained 3. Karnofsky Performance Status (KPS) > 70 4. Adults of either sex, between 18 years and above with a life expectancy of at least 6 months. 5. Adequate hematologic function (Absolute Neutrophil Count (ANC) >= 1,500 cells/ÂµL; Hemoglobin > 9 g/dL, platelets > 100,000/ÂµL and 6. Adequate renal function (serum creatinine = 45 ml/min) 7. Adequate hepatic function [bilirubin 8. Female patients must have a negative urine pregnancy test at pre-study (not applicable to patients with bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal) 9. All patients of reproductive potential must agree to use an approved form of contraception

Exclusion criteria

Exclusion criteria: 1. Nasopharyngeal, salivary glands, nasal cavities, maxillary sinus, paranasal sinus squamous cell carcinoma 2. Patients with a history of prior malignancy other than non-melanoma skin cancer or cervical cancer in-situ 3. Patients who have had immunotherapy 4. Patients who have received radiotherapy to head & neck 5. Known or suspected hypersensitivity to compounds with similarity to BIOMAb EGFR for eg. trastuzumab. 6. Patients with distant metastases 7. Pregnant or lactating women 8. Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease) 9. Known infection with HIV or Active viral hepatitis 10. Prior therapy that specifically and directly targets the EGFR pathway

Design outcomes

Primary

Measure	Time frame
To determine the Progression Free Survival to a combination of intravenous BIOMAb-EGFRÂ® (Nimotuzumab), cisplatin and radiotherapy in subjects with advanced [Stage III or IVA, B], histologically documented SCCHN.Timepoint: At the end of the study	—

Secondary

Measure	Time frame
1. Locoregional Response at 24 weeks from visit of randomization (V2) 2. Locoregional Control 3. Overall Survival, 4. Assessment of quality of life by filling EORTC questionnaire Timepoint: 1. Locoregional response at 24 weeks from Randomization 2. Locoregional control at 2 years 3. Overall survival at points of Interim analysis 3.5 years and at 5 years 4. QOL Assessment at every visit.	—

Countries

India

Contacts

Public ContactDr Kumar prabhash

Tata memorial hospital

kprabhash1@gmail.com9167760576

Outcome results

None listed