Metronomic study for Head & Neck cancer

Conditions

Health Condition 1: null- Cytologically or pathologically proven squamous cell carcinoma of head and neck. Treatment of the head and neck cancer with palliative intent

Patil V, Noronha V, Dhumal SB, Joshi A, Menon N, Bhattacharjee A, Kulkarni S, Ankathi SK, Mahajan A, Sable N, Nawale K, Bhelekar A, Mukadam S, Chandrasekharan A, Das S, Vallathol D, D'Souza H, Kumar A, Agrawal A, Khaddar S, Rathnasamy N, Shenoy R, Kashyap L, Rai RK, Abraham G, Saha S, Majumdar S, Karuvandan N, Simha V, Babu V, Elamarthi P, Rajpurohit A, Kumar KAP, Srikanth A, Ravind R, Banavali S, Prabhash K.

2020-09-0156 citations

10.1016/s2214-109x(20)30275-8

Low-cost oral metronomic versus intravenous chemotherapy in recurrent, inoperable and metastatic head and neck cancer: Phase III Metro-CIS study.

Nandini Sharrel Menon, Vanita Noronha, Vijay Patil, Sachin Dhumal, Amit Joshi et al. (11 authors)

Journal of Clinical Oncology2020-05-202 citations

10.1200/jco.2020.38.15_suppl.6506

Interventions

Intervention1: Not applicable: Not applicable Control Intervention1: Oral metronomic with Intravenous chemotherapy: Patients would be enrolled in the above mention study period and randomized between

Eligibility

Inclusion criteria

Inclusion criteria: 1. Site: Cytologically or pathologically proven squamous cell carcinoma of head and neck. Treatment of the head and neck cancer with palliative intent • Distant metastases from head-neck primary • Recurrent head-neck cancer presently not amenable to surgery or irradiation (are treated adequately at initial diagnosis) • Loco-regionally advanced stage disease deemed unsuitable for definitive surgery or radiotherapy (Patient could still be eligible for palliative radiotherapy for symptom relief) 2. Subjects between the ages of 18 - 70 yrs with Karnofsky performance scores >=70 3.Pretreatment normal hematological and biochemical parameters as defined below: 1. Hemoglobin : >= 8 mg/dL 2. Absolute neutrophil count >1500 3. Total Leucocyte counts > 3000 4. Platelet counts: 100,000 - 1000,000 /mm3 5. Creatinine Clearnce more than or equal to 45 ml/min. 4. Baseline liver function test within twice the normal limit for serum bilirubin.Patients should have signed the informed consent form and must be available for follow-up as outlined below.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: 1. Evidence of primary in Thyroid or salivary gland or nasopharynx 2. Patients with significant and uncontrolled co morbid conditions e.g. Diabetes Mellitus, Hypertension, COPD ,active Tuberculosis and HIV positive patients 3. Patients who have received cisplatin within last 3 months 4. Serological positive for HIV,HBV & HCV

Design outcomes

Primary

Measure	Time frame
Overall survivalTimepoint: Overall survival will be calculated from the date of randomization to the date of death due to any caus	—

Secondary

Measure	Time frame
Progression free survival(PFS)Timepoint: Progression free survival(PFS) will be calculated from the date of randomization to the date of disease progression	—

Countries

India

Contacts

Public ContactDr Amit Joshi

Tata Memorial Hospital

dramitjoshi74@gmail.com02224177000

Outcome results

None listed