Pathological response of chemotherapy in oral cancers
- Conditions
- Health Condition 1: null- Statge IV Oral Cavity Cancers(BorderlineResectable)
- Registration Number
- CTRI/2016/02/006609
- Lead Sponsor
- A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 60
1.Previously untreated borderline resectable oral cavity SCC i.e T4a lesions with skin induration.
2.Histological proven diagnosis of squamous cell cancer
3.Signed informed consent
4.Adequate organ function
•Hematological- Hb > 9 g/dL, ANC >= 1.5 x 109/L, platelets >= 100 x 109/L.
•Liver functions- bilirubin <= 2 x upper limit normal (ULN), S. albumin >= 30 g/L.
•Renal function- Creatinine <= 2 ULN, Creatinine clearance > 30 mL/min.
•Performance score (KPS) > 80 or ECOG <= 2
1. Distant metastasis present
2.Serious co-morbidities such as severe cardiac failure or severe pulmonary compromise or severe and active infections.
3.Locally advanced unresectable disease (T4b) or inoperable nodal disease
4.Patients not suitable for any chemotherapy.
5.Patient is currently enrolled in a clinical trial for another investigational therapy.
6.Pregnancy
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate patterns of tumor response and <br/ ><br>impact on surgical margins following <br/ ><br>neoadjuvant chemotherapy (NACT) in locally <br/ ><br>advanced oral cavity tumors.Timepoint: At surgery
- Secondary Outcome Measures
Name Time Method ATimepoint: NA