An Experimental Study to Compare Treatment Response and Toxicities of Concurrent Chemoradiation With Weekly Cisplatin and Three Weekly Cisplatin in Locally Advanced Head and Neck Cancer. (HNC)

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Status and phase: Completed; Phase 4

Conditions: Head and Neck Squamous Cell Carcinoma

Treatments: Drug: Cisplatin 40 mg/m2; Drug: Cisplatin 100 mg/m2

Study type: Interventional

Funder types: Other

Identifiers

NCT03998696

2017/311 (Other Identifier)

BSMMU/2017/1577

Details and patient eligibility

About

The aim of this study is to compare treatment responses and toxicities of concurrent chemo-radiation with weekly and three weekly Cisplatin in locally advanced Head & Neck Cancer. Half of the participants received Cisplatin (40 mg/m2) weekly with radiotherapy, while the other half received Cisplatin (100 mg/m2) thrice weekly with radiotherapy. Radiotherapy continued five days per week for six and half weeks.

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Biopsy proved, previously untreated, Squamous cell carcinoma of head & neck
• Stages III to IVB

Exclusion criteria

• Patients with history of prior chemotherapy or radiotherapy to the head and neck region.
• Initial surgery (excluding diagnostic biopsy) of the primary site.
• Patients with synchronous primaries.
• Those who are not willing to be included in the study.
• Pregnant or lactating woman.
• Serious medical illness
• Prisoners.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Weekly Cisplatin

Active Comparator group

Description:

Inj. Cisplatin 40 mg /m2 intravenous infusion delivered concurrently with radiotherapy on a weekly basis.

Treatment:

Drug: Cisplatin 40 mg/m2

Three weekly Cisplatin

Experimental group

Description:

Inj. Cisplatin 100 mg/m2 intravenous infusion delivered on a three weekly basis on days 1, 22 and 43 delivered concurrently with radiotherapy.

Treatment:

Drug: Cisplatin 100 mg/m2