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

A randomized prospective study comparing efficacy and toxicity between concurrent accelerated chemoradiotherapy vs concurrent chemoradiotherapy in locally advanced inoperable head and neck squamous cell cancer

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/10/021487

Enrollment

Registered

2019-10-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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 Health Condition 2: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx

Interventions

Intervention1: Concurrent accelerated chemoradiotherapy: 6 fractions per week radiation along with weekly cisplatin chemotherapy Control Intervention1: Concurrent chemoradiotherapy: 5 fractions radiat

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age more than 18 yrs and below 70 years 2. Performance status: Upto ECOG-2 3. Histologically & cytologically proven SC HNC. 4. Stage: III, IV, Non-metastatic 5. Measurable & evaluable disease without any severe systematic comorbidity or uncontrolled severe haematological abnormality. 6. Given informed written consent.

Exclusion criteria

Exclusion criteria: 1. Age: above 70 years. 2. Performance status: poorer than ECOG >2. 3. Stage: early stage &metastatic disease 4. Histologically any other than squamous cell carcinoma. 5. Previously treated with any type of radiation or chemotherapy: No other previous or co-existing malignancy. 6. Any severe systemic comorbidity or sever

Design outcomes

Primary

Measure	Time frame
To assess responsesTimepoint: 2 months	—

Secondary

Measure	Time frame
To assess toxicity and survivalTimepoint: 3 Months	—

Countries

India

Contacts

Public ContactPritam Kumar Sardar

Ipgmer sskm hospital

lekshmishenoi450@gmail.com

Outcome results

None listed

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