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Clinical Trials/CTRI/2016/04/006872
CTRI/2016/04/006872
Not yet recruiting
Phase 2

A randomized study for evaluation of metronomic adjuvant chemotherapy in recurrent head and neck cancers post R0 salvage surgical resection who are ineligible for re-irradiation.

Tata Memorial Hospital0 sites400 target enrollmentTBD
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ConditionsHealth Condition 1: null- recurrent head and neck cancers patients post R0 salvage surgical resection who are ineligible for re-irradiation.

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Health Condition 1: null- recurrent head and neck cancers patients post R0 salvage surgical resection who are ineligible for re-irradiation.
Sponsor
Tata Memorial Hospital
Enrollment
400
Status
Not yet recruiting
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

  • •1\.Patients with recurrenthead and neck cancers with primary in oral cavity, oropharynx, larynx or hypopharynx who have undergone complete salvage resection ( R0 resection)
  • •2\.Ineligibile for re\-irradiation in target region after assesement in joint clinic.
  • •3\.Age \>\=18 years
  • •4\.ECOG performance status PS 0\-2
  • •5\.Adequate bone marrow function (Haemoglobin \> 8 0g/L, platelets \> 100 x 109/L, ANC \> 1\.5 x 109/L)
  • •6\.Adequate liver function (ALT/AST \< 1\.5 x ULN, serum bilirubin \< 2mg/dl)
  • •7\.Adequate renal function (creatinine clearance \> 50 ml/min)
  • •8\.Adequate cardiac function (LVEF \>40%)
  • •9\.Study treatment both planned and able to start within 28 days of enrollment
  • •10\.Willing and able to comply with all study requirements, including treatment (able to swallow tablets), able to be followed up at regular intervals and/or nature of required assessments (e.g. able to have IV contrast if this is required for tumour assessments)

Exclusion Criteria

  • •1\.QTc prolongation (QTc B prolonged more than 450 millisecond)
  • •2\.Any significant active infection, including chronic active hepatitis B, hepatitis C, or HIV. for these is not mandatory unless clinically indicated. Participants with known Hepatitis B/C infection will be allowed to participate providing evidence of viral suppression has been documented and the patient remains on appropriate anti\-viral therapy.
  • •3\.Concurrent illness, including severe infection that may jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety; Serious medical (e.g. Diabetes Mellitus, Hypertension, COPD ,active Tuberculosis or psychiatric conditions that might limit the ability of the patient to comply with the protocol.
  • •4\.Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow\-up schedule, including alcohol dependence or drug abuse.
  • •5\.Pregnancy, lactation, or inadequate contraception. Women must be post menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or use a (double if required) barrier method of contraception.

Outcomes

Primary Outcomes

Not specified

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