Comparing efficacy and toxicity of Hypofractionated Radiotherapy and conventional radiotherapy

Hypofractionated Versus Conventional Fractionated Radiotherapy with concomitant Chemotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma- a single institutional Randomised Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/066503

Enrollment

110

Registered

2024-04-29

Start date

Unknown

Completion date

Unknown

Last updated

2024-05-27

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

Conditions

Health Condition 1: C139- Malignant neoplasm of hypopharynx,unspecified Health Condition 2: C109- Malignant neoplasm of oropharynx,unspecified Health Condition 3: C140- Malignant neoplasm of pharynx, unspecified

Interventions

Intervention1: CONVENTIONAL RADIOTHERAPY: Conventional radiotherapy (70 Gy, 35F, 5F/wk over 7 weeks) with concomitant weekly cisplatin(35mg/m2) Control Intervention1: HYPOFRACTIONATED RADIOTHERAPY WIT

Eligibility

Inclusion criteria

Inclusion criteria: Histological and cytological proven cases of stage II- IVb Squamous cell carcinoma of the head and neck Primary tumor sites Oropharynx, hypopharynx, larynx

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
To assess the treatment response in both the arms as per RECIST 1.1, or Response Evaluation Criteria in Solid Tumours version 1.1Timepoint: During treatment patients will be examined weekly. After treatment all the patients will be followed up every month for the next 6 months and then every three months till the end of the follow-up period Locoregional Control will be assessed 12weeks after completion of EBRT using same imaging modality used at baseline	—

Measure

Time frame

To assess the treatment response in both the arms as per RECIST 1.1, or Response Evaluation Criteria in Solid Tumours version 1.1Timepoint: During treatment patients will be examined weekly. After treatment all the patients will be followed up every month for the next 6 months and then every three months till the end of the follow-up period Locoregional Control will be assessed 12weeks after completion of EBRT using same imaging modality used at baseline

—

Secondary

Measure	Time frame
To assess the toxicity (Acute and late) in both arms using Common Terminology Criteria for Adverse Events (CTCAE v 6.0) To assess quality of life in both the arms as per EORTC QLQ-C30 and QLQ-HN43 To assess disease free survival in both the arms Timepoint: During treatment patients will be examined weekly. After treatment all the patients will be followed up every month for the next 6 months and then every three months till the end of the follow-up period Locoregional Control will be assessed 12weeks after completion of EBRT using same imaging modality used at baseline	—

Measure

Time frame

To assess the toxicity (Acute and late) in both arms using Common Terminology Criteria for Adverse Events (CTCAE v 6.0) To assess quality of life in both the arms as per EORTC QLQ-C30 and QLQ-HN43 To assess disease free survival in both the arms Timepoint: During treatment patients will be examined weekly. After treatment all the patients will be followed up every month for the next 6 months and then every three months till the end of the follow-up period Locoregional Control will be assessed 12weeks after completion of EBRT using same imaging modality used at baseline

—

Countries

India

Contacts

Public ContactAbhishek Basu

Department of Radiation Oncology at Burdwan Medical College and Hospital

Drabhishekbasu@yahoo.com9830303459

Outcome results

None listed

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