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OpenTrials
Completed

NCT Number: NCT03998696

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.

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.

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Key information

Conditions

Head and Neck Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bangabandhu Sheikh Mujib Medical University

Dhaka, 1000, Bangladesh

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cisplatin 40 mg/m2

Drug

Cisplatin 40 mg/m2, weekly, concurrent with Radiotherapy

Cisplatin 100 mg/m2

Drug

Cisplatin 100 mg/m2, three weekly, concurrent with Radiotherapy

Primary outcomes

  1. Loco-regional tumor control after completion of treatment

    Time frame: 6 months

    Response Evaluation Criteria in Solid Tumors was used to measure outcome:

    • Complete response (CR): Disappearance of all target lesions.
    • Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions.
    • Progressive disease (PD): At least a 20% increase in the sum of diameters of target lesions.
    • Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

  2. Treatment related toxicities during and after treatment

    Time frame: 8 months

    National Cancer Institute's Common Terminology Criteria for Advanced Events (version 4.03) was used measure toxicities.

Sponsors and collaborators

Lead sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Other

Registry information

Official study title

Comparison Between Two Regimens of Chemotherapy Concurrent With Radiotherapy in Locally Advanced Head and Neck Cancer

Acronym: HNC

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 26, 2019
Registry last updated
Jun 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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