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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03998696
Recruitment Status : Completed
First Posted : June 26, 2019
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Ishtiaq-Ur-Rahim, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinoma Drug: Cisplatin 40 mg/m2 Drug: Cisplatin 100 mg/m2 Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between Two Regimens of Chemotherapy Concurrent With Radiotherapy in Locally Advanced Head and Neck Cancer
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

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




Primary Outcome Measures :
  1. 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.

  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03998696


Locations
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Bangladesh
Bangabandhu Sheikh Mujib Medical University
Dhaka, Bangladesh, 1000
Sponsors and Collaborators
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Investigators
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Study Chair: Sarwar Alam, MBBS, Mphil Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Additional Information:
Publications:

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Responsible Party: Dr. Ishtiaq-Ur-Rahim, Principal Investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
ClinicalTrials.gov Identifier: NCT03998696    
Other Study ID Numbers: BSMMU/2017/1577
2017/311 ( Other Identifier: NICRH )
First Posted: June 26, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Access Criteria: To request an electronic copy send email to dr.iurahim@gmail.com

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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
Keywords provided by Dr. Ishtiaq-Ur-Rahim, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh:
Locally advanced
Head and Neck Cancer
Concurrent
Weekly Cisplatin
Three weekly Cisplatin
Radiotherapy
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Cisplatin
Antineoplastic Agents