A Randomized controlled study to evaluate accelerated fractionation(6days/week radiation) with standard best practice(5days/week radiation) in Head and Neck cancers with weekly Concurrent chemotherapy in both arm

A Randomized controlled study to evaluate accelerated fractionation with standard best practice in Head and Neck cancers (Concurrent chemoradiation)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/02/003410

Enrollment

Registered

2013-02-19

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: null- Histologically proven case of Head and Neck Cancer

Interventions

Intervention1: Accelerated fractionation Radiotherapy with concurrent chemotherapy: 2Gy/fr/day 6 days a week with concurrent cisplatin chemotherapy Intervention2: Accelerated fractionation Radiotherap

Eligibility

Inclusion criteria

Inclusion criteria: a. Informed consent b.Karnofsky performance scale between 70-100 c. Histologic proof of squamous cell carcinoma of larynx, oropharynx or hypopharynx, that is treatment naÃ¯ve. d.Stage IIâ??IVA. e.No evidence of distant metastases {Chest X ray, USG abdomen or PETCT(optional). f. a. No prior radiation treatment to the head and neck or any prior chemotherapy.

Exclusion criteria

Exclusion criteria: a.Synchronous malignancy b. Comobid condition like acute infections, chronic diseases such as renal, heart, liver (except Diabetes, Hypertension or Asthma). c.Any condition that in the Investigators opinion may impact the safety of the procedure.

Design outcomes

Primary

Measure	Time frame
To assess the therapeutic gain(efficacy) in terms Loco-regional control of accelerated treatment (6fraction/week) along with concurrent chemotherapy as compared to standard Radiotherapy of 5 fraction per week and concurrent chemotherapy in patients with head and neck cancersTimepoint: At 2 years	—

Secondary

Measure	Time frame
Impact of quality of life of this accelerated chemoradiation with EORTC H& N 35 Quality of life questionnaireTimepoint: At treatment completion and subsequent follow up;To assess the tolerability of 6 days of radiotherapy and chemotherapy (acute and late toxicity).Timepoint: At treatment completion and subsequent follow up;To evaluate the therapeutic gain in terms of disease free survival and overall survival.Timepoint: At 2 years	—

Measure

Time frame

Impact of quality of life of this accelerated chemoradiation with EORTC H& N 35 Quality of life questionnaireTimepoint: At treatment completion and subsequent follow up;To assess the tolerability of 6 days of radiotherapy and chemotherapy (acute and late toxicity).Timepoint: At treatment completion and subsequent follow up;To evaluate the therapeutic gain in terms of disease free survival and overall survival.Timepoint: At 2 years

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Countries

India

Contacts

Public ContactDr Deepak Gupta

Medanta-The Medicity

teji1960@gmail.com9810643131

Outcome results

None listed

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