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Clinical Trials/CTRI/2014/07/004791
CTRI/2014/07/004791
Completed
Phase 2

A prospective randomized phase II Study comparing metronomic chemotherapy with chemotherapy (single agent cisplatin),in patients with metastatic, relapsed or inoperable squamous cell carcinoma of Head and Neck

Tata Memorial Hospital0 sites110 target enrollmentTBD
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Tata Memorial Hospital
Enrollment
110
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Metasatatic ,recurrent or locally advanced head and neck cancers deemed unsuitable for loco\-regional treatment.
  • •Histologically proven squamous cell cancer
  • •Age group 18\-70years
  • •Karnofsky performance status more than or equal to 70
  • •Normal pretreatment haemaotological and biochemical parameters as defined below
  • •Haemoglobin:8\-18mg/dl
  • •Absolute Neutrophil count more than 1000/mm3
  • •Total leucocyte count 3000\-10,000/mm3
  • •Platelet count \-1\-4lakhs/mm3
  • •S urea and S creatnine below 45 and 1\.2 respectively.

Exclusion Criteria

  • •Primary in thyroid,salivary gland or nasopharynx
  • •patients with significant and uncontrolled comorbid conditions like DM,Hypertension,COPD,active tuberculosis and HIV positive patients
  • •Patients who have received cisplatin within last 3 months
  • •serological positive for HIV,HCV and HBV

Outcomes

Primary Outcomes

Not specified

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