A study to see if chemotherapy if given before surgery is beneficial in oral cavity cancer
- Conditions
- Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
- Registration Number
- CTRI/2022/12/048386
- Lead Sponsor
- Cancer Research and Statistics Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Subjects must have T3N2-N3 or T4 HNSCC in the oral cavity.
2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
3. Subjects must have normal organ and marrow function as per institute protocols.
4. Patients with HIV are potentially eligible, as long as they have a CD4 count > 200, are on concurrent HAART (highly active antiretroviral therapy), and have an absence of active AIDS-defining conditions.
5. Both men and women of all races and ethnic groups are eligible for this study.
6. Willing and able to comply with all study requirements, including treatment, able to be followed up at regular intervals, and/or nature of required assessments.
7. Ability to understand and the willingness to sign a written informed consent document.
1. Subjects who are receiving any other investigational agents.
2. Within 2 weeks of administration of a chemotherapeutic agent.
3. Current use of immunosuppressive medication, EXCEPT for the following:
a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection);
b. Systemic corticosteroids at physiologic doses = 10 mg/day of prednisone or equivalent;
c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
d. Steroids for raised intracranial pressure due to the disease itself e, Steroids use for avoidance or treatment of emesis.
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 ( < 6 months prior to enrollment), myocardial infarction ( < 6 months prior to enrollment), unstable angina, congestive heart failure (= 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. Active infection requiring systemic therapy.
7. Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI-CTCAE v4.03 Grade = 3).
8. Pregnant and lactating women are excluded from this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease-free survival (DFS)Timepoint: DFS will be the duration in days from the date of randomization to the date of progression or death whichever was earlier. <br/ ><br>DFS cannot be calculated at a specific time point.
- Secondary Outcome Measures
Name Time Method Overall survival (OS) and adverse event rate (ADR)Timepoint: 1. OS will be the duration in years from date of randomization to date of death. In patients who were alive till the last follow up this duration will be calculated from the date of randomization to the date of the last follow-up. <br/ ><br> <br/ ><br>2. ADR will be calculated as a percentage of patients having adverse events. CTCAE version 5.0 will be used. <br/ ><br> <br/ ><br>The endpoints cannot be calculated at a specific time point. Kindly refer to the definitions.