Comparison of effectiveness and tolerance of Single drug Methotrexate or Combination of drugs i.e. Methotrexate and Gefitinib drug in patients with very advanced head and neck cancer

Phase 3

Conditions: Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Registration Number: CTRI/2021/04/032577

Lead Sponsor: JIPMER

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall SurvivalTimepoint: Median overall survival

Secondary Outcome Measures

Name	Time	Method
Acute ToxicitiesTimepoint: Acute toxicity comparison between two arms will be done at study completion;Overall Response rate <br/ ><br>Disease control rate <br/ ><br>Timepoint: ORR and DCR will be compared between two arms at study completion;Progression free survivalTimepoint: Median Progression free survival