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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)

Primary Purpose

Head and Neck Squamous Cell Carcinoma

Status

Completed

Phase

Phase 4

Locations

Bangladesh

Study Type

Interventional

Intervention

Cisplatin 40 mg/m2

Cisplatin 100 mg/m2

About this trial

This is an interventional treatment trial for Head and Neck Squamous Cell Carcinoma focused on measuring Locally advanced, Head and Neck Cancer, Concurrent, Weekly Cisplatin, Three weekly Cisplatin, Radiotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

Bangabandhu Sheikh Mujib Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Weekly Cisplatin

Three weekly Cisplatin

Arm Description

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

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

Outcomes

Primary Outcome Measures

Loco-regional tumor control after completion of treatment

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.

Treatment related toxicities during and after treatment

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03998696

First Posted

June 22, 2019

Last Updated

June 26, 2019

Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

1. Study Identification

Unique Protocol Identification Number

NCT03998696

Brief Title

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.

Acronym

HNC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

July 1, 2017 (Actual)

Primary Completion Date

June 30, 2018 (Actual)

Study Completion Date

December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Squamous Cell Carcinoma

Keywords

Locally advanced, Head and Neck Cancer, Concurrent, Weekly Cisplatin, Three weekly Cisplatin, Radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Weekly Cisplatin

Arm Type

Active Comparator

Arm Description

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

Arm Title

Three weekly Cisplatin

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Cisplatin 40 mg/m2

Intervention Description

Cisplatin 40 mg/m2, weekly, concurrent with Radiotherapy

Intervention Type

Drug

Intervention Name(s)

Cisplatin 100 mg/m2

Intervention Description

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

Primary Outcome Measure Information:

Title

Loco-regional tumor control after completion of treatment

Description

Time Frame

6 months

Title

Treatment related toxicities during and after treatment

Description

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

Time Frame

8 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sarwar Alam, MBBS, Mphil

Organizational Affiliation

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Official's Role

Study Chair

Facility Information:

Facility Name

Bangabandhu Sheikh Mujib Medical University

City

Dhaka

ZIP/Postal Code

1000

Country

Bangladesh

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Access Criteria

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

Citations:

PubMed Identifier

12506176

Citation

Adelstein DJ, Li Y, Adams GL, Wagner H Jr, Kish JA, Ensley JF, Schuller DE, Forastiere AA. An intergroup phase III comparison of standard radiation therapy and two schedules of concurrent chemoradiotherapy in patients with unresectable squamous cell head and neck cancer. J Clin Oncol. 2003 Jan 1;21(1):92-8. doi: 10.1200/JCO.2003.01.008.

Results Reference

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PubMed Identifier

17998687

Citation

Geeta SN, Padmanabhan TK, Samuel J, Pavithran K, Iyer S, Kuriakose MA. Comparison of acute toxicities of two chemotherapy schedules for head and neck cancers. J Cancer Res Ther. 2006 Jul-Sep;2(3):100-4. doi: 10.4103/0973-1482.27584.

Results Reference

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PubMed Identifier

27602493

Citation

Guan J, Zhang Y, Li Q, Zhang Y, Li L, Chen M, Xiao N, Chen L. A meta-analysis of weekly cisplatin versus three weekly cisplatin chemotherapy plus concurrent radiotherapy (CRT) for advanced head and neck cancer (HNC). Oncotarget. 2016 Oct 25;7(43):70185-70193. doi: 10.18632/oncotarget.11824.

Results Reference

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PubMed Identifier

18607863

Citation

Ho KF, Swindell R, Brammer CV. Dose intensity comparison between weekly and 3-weekly Cisplatin delivered concurrently with radical radiotherapy for head and neck cancer: a retrospective comparison from New Cross Hospital, Wolverhampton, UK. Acta Oncol. 2008;47(8):1513-8. doi: 10.1080/02841860701846160.

Results Reference

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PubMed Identifier

29053029

Citation

Jacinto JK, Co J, Mejia MB, Regala EE. The evidence on effectiveness of weekly vs triweekly cisplatin concurrent with radiotherapy in locally advanced head and neck squamous cell carcinoma (HNSCC): a systematic review and meta-analysis. Br J Radiol. 2017 Nov;90(1079):20170442. doi: 10.1259/bjr.20170442.

Results Reference

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PubMed Identifier

26705681

Citation

Lee JY, Sun JM, Oh DR, Lim SH, Goo J, Lee SH, Kim SB, Park KU, Kim HK, Hong DS, Kim JS, Kim SG, Yi SY, Yun HJ, Hyun MS, Kim HJ, Jung SH, Park K, Ahn YC, Ahn MJ. Comparison of weekly versus triweekly cisplatin delivered concurrently with radiation therapy in patients with locally advanced nasopharyngeal cancer: A multicenter randomized phase II trial (KCSG-HN10-02). Radiother Oncol. 2016 Feb;118(2):244-50. doi: 10.1016/j.radonc.2015.11.030. Epub 2015 Dec 17.

Results Reference

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PubMed Identifier

23245290

Citation

Tsan DL, Lin CY, Kang CJ, Huang SF, Fan KH, Liao CT, Chen IH, Lee LY, Wang HM, Chang JT. The comparison between weekly and three-weekly cisplatin delivered concurrently with radiotherapy for patients with postoperative high-risk squamous cell carcinoma of the oral cavity. Radiat Oncol. 2012 Dec 18;7:215. doi: 10.1186/1748-717X-7-215.

Results Reference

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Links:

URL

http://gco.iarc.fr/today/fact-sheets-populations

Description

Global Cancer Observatory (GLOBOCAN), 2018.

Learn more about this trial

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.

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