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A study to see how taking breaks during treatment with combined chemotherapy and radiotherapy affects recovery and disease progression in people with head and neck cancer patients.

A Prospective Observational study to assess the Impact of Treatment Interruption on disease outcome in Head and Neck Squamous Cell Carcinoma treated with Concomitant Chemo- Radiotherapy. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/12/099280
Enrollment
96
Registered
2025-12-17
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

Intervention1: Concurrent Chemo-Radiotherapy to treat Head and Neck Squamous Cell Carcinoma: EBRT with 2 Grey per fraction, one fraction per day, 5 days per week for 6.5 weeks (Monday to Friday) resu

Sponsors

Shreshth Vinaik
Lead Sponsor
Institute of Post Graduate Medical Education and Research Kolkata
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: A. Patients willing to participate in the study by giving written consent. B. Histopathologically proven Head and Neck Squamous cell carcinoma C. Follows AJCC TNM Staging: will include T3 and T4 stages and/or N1-3 and M0 D. Adult patient (20 years to 70 years) E. Performance status (ECOG 0-2) F. Normal haematological parameters at the time of start of the treatment: Haemoglobin more than 10 gm/dL, Absolute Neutrophil Count (ANC) more than 1500/cu.mm., Platelet count more than 1L/cu.mm. G. Normal biochemical blood parameters like Liver function test and Renal function test: Liver enzymes (ALT/AST) less than 3UNL, Est. Creatinine Clearance more than 50 H. Patient willing to come for follow up.

Exclusion criteria

Exclusion criteria: 1. Carcinoma of the Nasopharynx 2. Patients requiring Neoadjuvant Chemotherapy 3. Comorbidities, unrelated to the disease in study 4. Prior treatment with radiotherapy or surgery with curative intent for the disease under study/ Recurrent disease 5. Any second primary or other malignancies within the last 5 years 6. Pregnant patients

Design outcomes

Primary

MeasureTime frame
To determine the Impact of Treatment Interruption on overall disease response and Progression Free Survival of patients treated with Concomitant Chemo-Radiotherapy for Head and Neck Squamous Cell Carcinoma.Timepoint: 3 weeks, 3 months, and then 3 monthly follow ups—

Secondary

MeasureTime frame
To find out the factors causing treatment interruption in Head & Neck Squamous Cell Carcinoma patient on Concomitant Chemo-RadiotherapyTimepoint: End of Treatment ie after the 45 day long standard Radiation Regime—

Countries

India

Contacts

Public ContactDr Niladri B Patra

Institute of Post Graduate Medical Education and Research Kolkata

nbpatra@gmail.com9874038399

Outcome results

None listed

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