Higher cumulative dose, 6days/week vs standard, 5days/week moderately hypofractionated palliative radiotherapy with concurrent chemotherapy in locally advanced head and neck carcinoma.

Accelerated Hypofractionated Palliative Radiotherapy Vs Standard Hypofractionated Palliative Radiotherapy With Concurrent Chemotherapy In Locally Advanced Head And Neck Carcinoma: A Randomised Controlled Study - nil

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/058621

Enrollment

Registered

2023-10-13

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

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

Conditions

Health Condition 1: C01- Malignant neoplasm of base of tongue Health Condition 2: C04- Malignant neoplasm of floor of mouth Health Condition 3: C03- Malignant neoplasm of gum Health Condition 4: C13- Malignant neoplasm of hypopharynx Health Condition 5: C00- Malignant neoplasm of lip Health Condition 6: C10- Malignant neoplasm of oropharynx Health Condition 7: C14- Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx Health Condition 8: C02- Malignant neoplasm of

Interventions

Intervention1: Accelerated hypofractionated palliative radiotherapy with concurrent weekly cisplatin. This would be followed by radical conversion in case of partial to complete response.: 42Gy in 12

Eligibility

Inclusion criteria

Inclusion criteria: -Treatment naive, Histo-pathologically proven Squamous Cell Carcinoma of head and neck region excluding nasopharyngeal, para-nasal sinus and salivary gland primary -Defined as incurable or palliative intent by Head and Neck multidisciplinary team (MDT) -Adequate organ functions and bone marrow reserve -Eastern Co-operative Oncology Group Performance Score (ECOG PS)- (0-3) -Age: 18- 70 years -Negative viral serology markers (HIV, HBsAg, HCV) -Giving written Informed consent

Exclusion criteria

Exclusion criteria: -Nasopharyngeal, para-nasal sinus or salivary gland primary -Recurrent disease -Metastatic disease -Patients who have previously received oncologic treatment with surgery, radiotherapy or chemotherapy -Pregnant patients -Synchronous malignancy or any other malignancy with in last 5 years -Known uncontrolled medical comorbidities which could impact QOL

Design outcomes

Primary

Measure	Time frame
Tumour Response Rate Quality of LifeTimepoint: Tumor Response- 3 weeks, 3 months, 6 months after palliative radiotherapy completion. Quality of Life- baseline, 3 months, 6 months after palliative radiotherapy completion.	—

Secondary

Measure	Time frame
Assessment of Acute ToxicitiesTimepoint: 3 months;Overall SurvivalTimepoint: 6 months;Progression Free SurvivalTimepoint: 6 months	—

Countries

India

Contacts

Public ContactDr Suman Bhasker

Department of Radiation Oncology, AIIMS, New Delhi

drsumanbhasker@gmail.com9811093418

Outcome results

None listed

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