A clinical trial to compare the effect of two neoadjuvant chemotherapy drug regimens in technically unresectable head and neck cancer.

A prospective comparative analysis of two neoadjuvant chemotherapy protocols in technically unresectable head and neck cancer. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/075166

Enrollment

Registered

2024-10-11

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-14

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

Conditions

Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx

Interventions

Intervention1: ARM A - NEOADJUVANT CHEMOTHERAPY REGIMEN 1. Inj. PACLITAXEL 2. Inj. CISPLATIN 3. inj. 5 FLURO-URACIL (5FU): ON WEEKLY BASIS FOR 9 CYCLES:- 1. Inj. PACLITAXEL DOSE- 100 mg IV infusion

Eligibility

Inclusion criteria

Inclusion criteria: a. Age between 18 - 75 yrs. b. ECOG performance status (ECOG PS): =3 c. Biopsy proven of Head and Neck region d. Carcinoma Head & Neck staged IVA – IVB of all sub-sites namely Oral Cavity / Oropharynx / Hypo-pharynx /Larynx / Nasopharyngeal / Para-nasal sinus and Salivary gland primary. e. Technically unresectable head and neck cancer in view of local invasion. f. No synchronous / metachronous malignancy. g. No prior cancer directed Treatment. h. Giving written informed consent.

Exclusion criteria

Exclusion criteria: a. ECOG performance status (ECOG PS) b. Any prior oncologic treatment with surgery, chemotherapy or radiotherapy. c. Any co-morbidity which compromises treatment schedules e.g. Severe cardio-respiratory disease, renal-disease etc. d. Patients refusing to give written informed consent

Design outcomes

Primary

Measure	Time frame
1. Compare proportion of patients eligible for radical treatment. 2. Assess loco-regional disease control at 3 and 6 months.Timepoint: 18 months	—

Secondary

Measure	Time frame
1. Assess and compare the degree of symptom relief and palliation 2. To compare toxicity between armsTimepoint: 18 months	—

Countries

India

Contacts

Public ContactRam Pukar Bharat

Jawaharlal Nehru Medical College(Sawangi,) Wardha , Maharashtra

amolpgi@yahoo.co.in9386950771

Outcome results

None listed

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