To study response rate after chemotherapy in inoperable of head and neck cancers.

Open label, non controlled, non randomized, interventional pilot study to evaluate the response rate after induction therapy with Docetaxel (T) and cisplatin (P) in unresectable locally advanced squamous cell carcinoma of head and neck. - Direct Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/08/006080

Enrollment

Registered

2015-08-06

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients with histologically confirmed, unresectable locally advanced SCCHN of oral cavity, oropharynx, larynx or hypopharynx in stage IIIâ??IV without evidence of distant metastases

Interventions

Intervention1: single arm study: 3 weekly Docetaxel and Cisplatin for 3 cycles unresectable locally advanced squamous cell carcinoma of head and neck. Intervention2: NIl: NIL Intervention3: Docetaxel

Eligibility

Inclusion criteria

Inclusion criteria: (i) histologically confirmed, unresectable locally advanced SCCHN of oral cavity, oropharynx, larynx or hypopharynx in stage IIIâ??IV without evidence of distant metastases (ii) no prior chemotherapy or radiation therapy; (iii) having at least one measurable lesion in one dimension; (iv) age >18 & (v) adequate haematological function with neutrophil count P1500/ml, platelets >100,000/ml and haemoglobin >10 g/ml; (vi) adequate hepatic function with bilirubin (vii) renal function within normality with serum creatinine 60 ml/ min calculated by the Cockcroftâ??Gault method.

Exclusion criteria

Exclusion criteria: (i) Peripheral neuropathy or other serious diseases (unstable ischaemic heart disease, acute myocardial infarction 6 months prior to inclusion, history of significant neurological or psychiatric disorder or active peptic ulcer) (ii) Being treated concomitantly with corticosteroids (except as pre-medication) (iii) Patients having another type of neoplasm. (iv) Previous chemotherapy or radiotherapy (v) Any previous definitive surgery for squamous cell carcinoma of head and neck (vi) Severe weight loss ( > 20 % of body weight) in the preceding 3 months

Design outcomes

Primary

Measure	Time frame
To evaluate the overall response (OR) rate (including CR and partial response (PR)) of subjects treated with induction regimen Docetaxel and cisplatin with locally advanced head and neck cancer. Timepoint: Response after Neoadjuvant Chemotherapy	—

Secondary

Measure	Time frame
To assess the safety and tolerability of induction regimen Docetaxel and cisplatin in patients with locally advanced head and neck cancer.Timepoint: safety profile at every cycle	—

Countries

India

Contacts

Public ContactDr Kumar Prabhash

Tata Memorial Hospital

kprabhash1@gmail.com022241777214

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026