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)

June 26, 2019 updated by: Dr. Ishtiaq-Ur-Rahim, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Comparison Between Two Regimens of Chemotherapy Concurrent With Radiotherapy 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh, 1000
        • Bangabandhu Sheikh Mujib Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Weekly Cisplatin
Inj. Cisplatin 40 mg /m2 intravenous infusion delivered concurrently with radiotherapy on a weekly basis.
Drug: Cisplatin 40 mg/m2
Cisplatin 40 mg/m2, weekly, concurrent with Radiotherapy
Experimental: Three weekly Cisplatin
Inj. Cisplatin 100 mg/m2 intravenous infusion delivered on a three weekly basis on days 1, 22 and 43 delivered concurrently with radiotherapy.
Drug: Cisplatin 100 mg/m2
Cisplatin 100 mg/m2, three weekly, concurrent with Radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Loco-regional tumor control after completion of treatment
Time Frame: 6 months

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Investigators

  • Study Chair: Sarwar Alam, MBBS, Mphil, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

June 22, 2019

First Submitted That Met QC Criteria

June 25, 2019

First Posted (Actual)

June 26, 2019

Study Record Updates

Last Update Posted (Actual)

June 28, 2019

Last Update Submitted That Met QC Criteria

June 26, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BSMMU/2017/1577
  • 2017/311 (Other Identifier: NICRH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Access Criteria

To request an electronic copy send email to dr.iurahim@gmail.com

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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