Role Of G-CSF In Preventing Chemoradiation Induced Mucositis In Locally Advanced Head And Neck Cancer Patients : A Prospective Randomised Study

Effect Of Granulocyte Colony Stimulating Factor Administration On Chemoradiation Induced Mucositis In Locally Advanced Head And Neck Cancer Patients A Prospective Randomized Study - GAMMA-HN

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/105195

Enrollment

Registered

2026-03-02

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Health Condition 1: -

Interventions

Intervention1: FILGRASTIM: FILGRASTIM GIVEN IN LOCALLY ADVANCED HEAD AND NECK CANCER PATIENTS ON CONCURRENT CHEMORADIATION Control Intervention1: FILGRASTIM IN PATIENTS IN EXPERIMENTAL GROUP: FILGRAST

Eligibility

Inclusion criteria

Inclusion criteria: 1.Histopathologically proven head and neck squamous cell carcinoma 2.Patients presenting with AJCC Clinical stage III-IV, nonmetastatic head and neck carcinoma 3.Age between 18 and 70 years. 4.Patients with ECOG performance status of 0 1 5.Patients who are willing to give an approved informed consent. 6.GFR more than 45ml/min/1.73m

Exclusion criteria

Exclusion criteria: 1.Patients who had prior underwent surgery or neoadjuvant chemotherapy for Head and Neck carcinoma. 2.Patients with proven/known distant metastasis. 3.Patients having hypersensitivity to G-CSF. 4.Patients who have not consented to be a part of the study. 5.Pregnant women and lactating mother.

Design outcomes

Primary

Measure	Time frame
To assess the incidence and severity of oral mucositis in patients receiving concurrent chemo radiotherapy with three weekly cisplatin, with weekend G-CSF administration.Timepoint: During RT (weekly twice) and Monthly once for 3 months after treatment	—

Secondary

Measure	Time frame
To compare tumor response between patients receiving concurrent chemo radiotherapy with three weekly cisplatin with weekend G-CSF administration & those receiving concurrent chemo radiotherapy with three weekly cisplatin without G-CSF administration.Timepoint: 3months after treatment	—

Countries

India

Contacts

Public ContactDr.B.V.Subramanian

Sri Venkateswara Institute of Medical Sciences

ravibalasubramanian@hotmail.com9849692950

Outcome results

None listed

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