We are comparing two arm of treatment ,compare short course palliative Radiotherapy with short course concurrent palliative Chemotherapy plus radiotherapy in advanced and unresectable head and neck cancer .

A Phase 2 randomized study to compare short course palliative Radiotherapy with short course concurrent palliative Chemotherapy plus radiotherapy in advanced and unresectable head and neck cancer .

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/06/002717

Enrollment

100

Registered

2012-06-06

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- Head and Neck Cancer

Interventions

Intervention1: short course of concurrent palliative chemotherapy plus radiotherapy: Inj Cisplatin @ 6mg/m2 IV push in 50 ml normal saline over 10 minutes D1-D5 along with radiotherapy 20gray 5 fracti

Eligibility

Inclusion criteria

Inclusion criteria: A Biopsy proven Squamous cell carcinoma of the Head and Neck region. B ECOG Performance Status of 1/2/3. C T4b and /or N3 TUMOUR that had been unanimously defined as inoperable and incurable by multidisciplinary team members. D Sites â??oral cavity, oropharynx, hypopharynx.

Exclusion criteria

Exclusion criteria: A Patients with ECOG PS 4 B Non-squamous histology. C H/o previous malignancy at same or other site. D Patients who has received Radiotherapy or Chemotherapy in the past either from IRCH or from other centre.

Design outcomes

Primary

Measure	Time frame
1.To assess locoregional disease control at 6 months between patients with short course palliative Radiotherapy PRT versus patients with short course concurrent palliative Chemotherapy plus radiotherapy CTRT in advanced and unresectable head and neck cancer. 2.Proportion of patients eligible for radical RT versus radical CT and RT in each treatment arm. Timepoint: 6 months from the date of randomization.	—

Measure

Time frame

1.To assess locoregional disease control at 6 months between patients with short course palliative Radiotherapy PRT versus patients with short course concurrent palliative Chemotherapy plus radiotherapy CTRT in advanced and unresectable head and neck cancer. 2.Proportion of patients eligible for radical RT versus radical CT and RT in each treatment arm. Timepoint: 6 months from the date of randomization.

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Secondary

Measure	Time frame
1. To assess for degree of symptom relief & palliation between two groups. 2. To compare progression free survival and overall survival between two groups 3. To compare toxicity between two groups. Timepoint: at one month and six month.	—

Countries

India

Contacts

Public ContactArvind Kumar

All India Institute of Medical Sciences

atul1@hotmail.com01126589490

Outcome results

None listed

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