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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief Summary
The outcome We plan to reach with this research is to best find the impact of prolonged overall treatment time due to treatment interruptions in a planned RT schedule of HNSCC patients on the overall response and disease progression of the patients. We expect by this study to see that a delay in treatment will lead to poor outcomes in the patients. The poor outcomes that are caused by such RT delays in our setting will serve as a suggestion to find out the causes and remedy them, especially the easily avoidable factors.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 20.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients willing to participate in the study by giving written consent.
- •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.
- •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
- •Carcinoma of the Nasopharynx
- •Patients requiring Neoadjuvant Chemotherapy
- •Comorbidities, unrelated to the disease in study
- •Prior treatment with radiotherapy or surgery with curative intent for the disease under study/ Recurrent disease
- •Any second primary or other malignancies within the last 5 years
- •Pregnant patients.
Outcomes
Primary Outcomes
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.
Time Frame: 3 weeks, 3 months, and then 3 monthly follow ups
Secondary Outcomes
- To find out the factors causing treatment interruption in Head & Neck Squamous Cell Carcinoma patient on Concomitant Chemo-Radiotherapy(End of Treatment ie after the 45 day long standard Radiation Regime)
Investigators
Shreshth Vinaik
Institute of Post Graduate Medical Education and Research Kolkata