MedDataX Logo

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.

NCT ID: NCT03998696

Last Updated: 2019-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Head and Neck Squamous Cell Carcinoma

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Weekly Cisplatin

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

Group Type ACTIVE_COMPARATOR

Cisplatin 40 mg/m2

Intervention Type DRUG

Cisplatin 40 mg/m2, weekly, concurrent with Radiotherapy

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.

Group Type EXPERIMENTAL

Cisplatin 100 mg/m2

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cisplatin 40 mg/m2

Cisplatin 40 mg/m2, weekly, concurrent with Radiotherapy

Intervention Type DRUG

Cisplatin 100 mg/m2

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Ishtiaq-Ur-Rahim

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sarwar Alam, MBBS, Mphil

Role: STUDY_CHAIR

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bangabandhu Sheikh Mujib Medical University

Dhaka, , Bangladesh

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Bangladesh

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 12506176 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17998687 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27602493 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18607863 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29053029 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26705681 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23245290 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

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

Global Cancer Observatory (GLOBOCAN), 2018.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017/311

Identifier Type: OTHER

Identifier Source: secondary_id

BSMMU/2017/1577

Identifier Type: -

Identifier Source: org_study_id