CTRI/2024/01/061661
Not yet recruiting
Phase 3
A Phase III ,Randomized controlled study comparing triple oral metronomic chemotherapy with low dose immunotherapy to intravenous chemotherapy in patients with advanced platinum sensitive head and neck squamous cell carcinoma in first line palliative setting. - NSCLC TMCI chemo
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
- Sponsor
- Tata Memorial Centre
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1 Subjects must have head and neck squamous cell carcinoma and must be planned
- •for palliative systemic therapy in the first line.
- •2 Patients who have received prior platinum chemotherapy in the definitive setting will be eligible as long as the disease has relapsed 6 months or beyond the time that they had received platinum therapy.
- •Age more than 18 years.
- •Eastern Cooperative Oncology Group ECOG performance status PS 0 2
- •3 Subjects must have normal organ and marrow function
- •4 Patients with HIV are potentially eligible as long as they have a CD4 count more than and equal to 200 are on concurrent HAART highly active antiretroviral therapy, and absence of active AIDS defining conditions.
- •5 Pregnancy test Negative serum or urine pregnancy test at screening for women of
- •childbearing potential.
- •6 Contraception Highly effective contraception for both male and female subjects throughout
Exclusion Criteria
- •1\. Subjects who are receiving any other current investigational agents.
- •2\. IMMUNOSUPPRESSANTS Current use of immunosuppressive medication EXCEPT for the
- •a. intranasal, inhaled, topical steroids, or local steroid injection
- •b. Systemic corticosteroids at physiologic doses more than and equal to 10 mg per day of prednisone or equivalent
- •c. Steroids as premedication for hypersensitivity reactions
- •d. Steroids for raised intracranial pressure due to the disease itself e, Steroid use
- •for avoidance or treatment of emesis.
- •3\. AUTOIMMUNE DISEASE Active autoimmune disease that might deteriorate when receiving
- •a chemotherapeutic agent. Patients with diabetes type I vitiligo psoriasis or hypo or
- •hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
Outcomes
Primary Outcomes
Not specified
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