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.

Overview

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.

Full Title of Study: “Comparison Between Two Regimens of Chemotherapy Concurrent With Radiotherapy in Locally Advanced Head and Neck Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 30, 2018

Interventions

  • Drug: Cisplatin 40 mg/m2
    • Cisplatin 40 mg/m2, weekly, concurrent with Radiotherapy
  • Drug: Cisplatin 100 mg/m2
    • Cisplatin 100 mg/m2, three weekly, concurrent with Radiotherapy

Arms, Groups and Cohorts

  • Active Comparator: Weekly Cisplatin
    • Inj. Cisplatin 40 mg /m2 intravenous infusion delivered concurrently with radiotherapy on a weekly basis.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Ishtiaq-Ur-Rahim, Principal Investigator – Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
  • Overall Official(s)
    • Sarwar Alam, MBBS, Mphil, Study Chair, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

References

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.

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.

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.

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.

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.

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.

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.

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