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In this trial we are assessing the safety and efficacy and any difference in treatment outcome ââ?¬Å?Combination of Chemotherapy and External Radiation Therapy with 3 weeky and weekly Cisplatin.

Concurrent Chemotherapy and External Radiation Therapy:An Open Label Non-Inferiority Phase III Randomized Controlled Trial of Weekly versus ThreeWeeklyCisplatinandRadical Radiotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma - head and neck cancer,chemotherapy,radiotherapy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/03/012422
Enrollment
286
Registered
2018-03-08
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: null- Locally advance Head and Neck Squamous Cell Carcinoma Cancer Patients

Interventions

Intervention1: Radiotherapy with weekly Cisplatin: Cisplatin 40mg/m2 with Radiotherapy Control Intervention1: Radiotherapy with Cisplatin: Cisplatin 100mg/m2 3 weekly with Radiotherapy

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed, chemo/radiotherapy na�¯ve, biopsy or cytology proven, locally advanced head and neck squamous cell carcinoma excluding nasopharyngeal carcinoma (stage III and IV without distant metastases) 2. Patients who are considered suitable for either definitive chemo-radiation after discussion in combined clinic(HN clinic) 3. No evidence of distant metastases on clinical examination or on chest x-ray 4. Age 18-70 years 5. ECOG PS 0-2 6. No contraindication to Cisplatin or radiotherapy 7. Adequate organ function at time of participation, defined as A. Hematological: Hemoglobin > 9gm/dl, ANC â�¥ 1500/cmm3, Platelet â�¥100000/cmm3 B. Liver Function test: Bilirubin â�¤2 x upper limit normal (ULN), AST/ALT/ ALP â�¤ 2.5 x ULN C. Renal Function test: Creatinine â�¤ 1.5 ULN, Creatinine Clearance â�¥60 ml/mins

Exclusion criteria

Exclusion criteria: 1. Uncontrolled concomitant other systemic disease 2. History of moderate to severe hearing loss 3. History of previous malignancy excluding non-melanoma skin cancers or cervical carcinoma in situ 4. Documented Weight loss of more than 15% in last 6 months 5. Patients with known HIV, hepatitis B or C infection 6. Patients with known distant metastases

Design outcomes

Primary

MeasureTime frame
Loco Regional Control Rate at 2 yearsTimepoint: Loco Regional Control Rate at 2 years—

Secondary

MeasureTime frame
1. Overall Survival 2. Progression Free survival 3. Grade 3-4chemotherapy toxicityas per CTCAE 4 criteria 4. Early or Late Radiation toxicityas per RTOG criteria 5. Compliance to the treatment 6. Baseline cardiac functions as estimated by 2D Echocardiography and serum lipid profile 7. Prognostic significance of pre-treatment LDH on survival and LRC Timepoint: 2 years—

Countries

India

Contacts

Public ContactDr Atul Sharma

All India Institute of Medical Sciences

atul1@hotmail.com9818548149

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 12, 2026