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Study of different type of chemotherapy in Head and Neck Cancer Patients

Phase 3
Conditions
Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
Registration Number
CTRI/2024/06/068752
Lead Sponsor
Tata Memorial Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Participants for radical or adjuvant CTRT for a histologically confirmed squamous cell of locally advanced head and neck region.

2.Age : Any age above 18 years. No maximum age.

3.ECOG performance status =2

4.Participants must be unfit for Cisplatin

Exclusion Criteria

1.Participants who are receiving any other investigational agents.

2.Primary sites of malignancy major salivary gland or nasopharynx or skin

3.Patients with uncontrolled comorbidities precluding the use of docetaxel or Carboplatin

4.

Uncontrolled comorbidities including active autoimmune disease that might deteriorate when receiving a chemotherapeutic agent. Clinically significant (i.e., active)cardiovascular disease: cerebrovascular accident/stroke (less than 6 months prior to enrollment), myocardial infarction (less than 6 months prior to enrollment), unstable angina, congestive heart failure (greater than equal to New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication. Patients with severe renal and liver dysfunction Child pugh B or C

5.Prior organ transplantation including allogeneic stem-cell transplantation.

6.Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI-CTCAE v5.0 Grade = 3).

7.Pregnant and lactating women are excluded from this study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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