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出境医 / 临床实验 / 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)

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)

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.

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

Study Design
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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
Arms and Interventions
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
Outcome Measures
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.


Eligibility Criteria
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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.
Contacts and Locations

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
Tracking Information
First Submitted Date  ICMJE June 22, 2019
First Posted Date  ICMJE June 26, 2019
Last Update Posted Date June 28, 2019
Actual Study Start Date  ICMJE July 1, 2017
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 25, 2019)
  • Loco-regional tumor control after completion of treatment [ Time Frame: 6 months ]
    According to RECIST criteria
  • Treatment related toxicities during and after treatment [ Time Frame: 8 months ]
    According to the National Cancer Institute's Common Terminology Criteria for Advanced Events (version 4.03)
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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.
Official Title  ICMJE Comparison Between Two Regimens of Chemotherapy Concurrent With Radiotherapy in Locally Advanced Head and Neck Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Head and Neck Squamous Cell Carcinoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Weekly Cisplatin
    Inj. Cisplatin 40 mg /m2 intravenous infusion delivered concurrently with radiotherapy on a weekly basis.
    Intervention: Drug: Cisplatin 40 mg/m2
  • 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.
    Intervention: Drug: Cisplatin 100 mg/m2
Publications *
  • 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.
  • 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.
  • 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. Review.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 25, 2019) 		60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2018
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bangladesh
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03998696
Other Study ID Numbers  ICMJE BSMMU/2017/1577
2017/311 ( Other Identifier: NICRH )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Access Criteria: To request an electronic copy send email to dr.iurahim@gmail.com
Responsible Party Dr. Ishtiaq-Ur-Rahim, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study Sponsor  ICMJE Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Sarwar Alam, MBBS, Mphil Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
PRS Account Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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