A study comparing efficacy and toxicity between 6 fractions per week radiotherapy vs 5 fractions per week radiotherapy along with weekly chemotherapy in both cases in locally advanced inoperable head and neck squamous cell cancer

Phase 2/3

Not yet recruiting

Conditions: Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, (2) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx,

Brief Summary: Approximately 50000 patients were diagnosed annually with squamous cell head and neck (HNC) in United States. Nearly 60% of this population presents with locally advanced but non-metastatic disease. Loco regional failure constitutes the predominant recurrence pattern due to accelerated repopulation of cancer cells.

In our study in standard arm, patients will receive 66 gy in 33# with weekly cisplatin @ 40 mg/meter2 in 6.5 weeks. 5 days per week schdule.

In our experimental arm we shall be giving 66 gy over 5 weeks 3 days in a 6 days per week schdule with concurrent inj cisplatin 40 mg/m^2 weekly.this study has following aims and objectives:

To study the difference between responses in the two arms, according to RECIST V1.1, in terms of Complete Response (CR), Partial Response (PR), Progressive Disease (PD) and Stable Disease (SD) at the end of the treatment.

To study the difference between acute toxicities in the arms, with the help of RTOG radiation morbidity criteria (CTC V1.1). To assess overall survival in both arm, disease free survival (for complete responders) and progression free survival (for partial responders and stable disease).

Recruitment & Eligibility

Inclusion Criteria

Age more than 18 yrs and below 70 years 2.
Performance status: Upto ECOG-2 3.
Histologically & cytologically proven SC HNC.
Stage: III, IV, Non-metastatic 5.
Measurable & evaluable disease without any severe systematic comorbidity or uncontrolled severe haematological abnormality.
Given informed written consent.

Exclusion Criteria

Age: above 70 years.
Performance status: poorer than ECOG>2.
Stage: early stage &metastatic disease 4.
Histologically any other than squamous cell carcinoma.
Previously treated with any type of radiation or chemotherapy: No other previous or co-existing malignancy.
Any severe systemic comorbidity or sever.

Primary Outcome Measures

Name	Time	Method
To assess responses	2 months

Secondary Outcome Measures

Name	Time	Method
To assess toxicity and survival	3 Months

Locations (1): Ipgmer Sskm hospital
🇮🇳
Kolkata, WEST BENGAL, India
Ipgmer Sskm hospital
🇮🇳Kolkata, WEST BENGAL, India
Pritam Kumar Sardar
Principal investigator
8420850866
pritam.ks1990@gmail.com