Weekly Methotrexate with or without Gefitinib in Residual/Recurrent or metastatic head and neck cancer patients: An open label randomized control trial.

JIPMER0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Histologically/ Cytologically confirmed Squamous cell carcinoma (SCC) of head and neck
•2.age 18-65 years
•3.Platinum naÃ¯ve HNSCC, ECOG-2-3: Planned for Palliative intent therapy
•4.Platinum resistant HNSCC, ECOG-0-3: Patients who had progressive disease on first-line platinum chemotherapy in recurrent/ metastatic SCC or residual disease with prior treatment with chemoradiotherapy as part of potentially curative intent within 6 months.

•1. Patients who are fit for salvage surgery / reirradiation for recurrent or residual disease/ platinum based chemotherapy
•2. Pregnant or breast feeding or pregnant female patients
•3. Patients having brain metastases.
•ï?¬Patients with creatinineclearance less than 50 ml/min.
•4. Uncontrolled medical comorbidities.
•5. Patients with HIV positivity and hepatitis B virus or hepatitis C virus related hepatitis
•6. Patients not willing for close follow up
•7. Primary in Nasopharynx, Thyroid or Salivary glands
•8. Major tumor related hemorrhagic events in the previous 3 months
•9. On Therapeutic anticoagulation (warfarin)
•10. With tumors that invaded major vessels
•11. Any third space fluid accumulation (edema, ascites, effusion)
•12.Known to be at risk of developing QT interval prolongation (e.g. hypokalemia, hypomagnesemia, bundle branch block, sinus node dysfunction) or with a known baseline QT interval >460 msec
•13. Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates
•14. Prior treatment with an EGFR inhibitor or Methotrexate

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