NCT03998696

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2019

Completed
Last Updated

June 28, 2019

Status Verified

June 1, 2019

Enrollment Period

12 months

First QC Date

June 22, 2019

Last Update Submit

June 26, 2019

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Locally advancedHead and Neck CancerConcurrentWeekly CisplatinThree weekly CisplatinRadiotherapy

Outcome Measures

Primary Outcomes (2)

  • Loco-regional tumor control after completion of treatment

    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.

    6 months

  • Treatment related toxicities during and after treatment

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

    8 months

Study Arms (2)

Weekly Cisplatin

ACTIVE COMPARATOR

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

Drug: Cisplatin 40 mg/m2

Three weekly Cisplatin

EXPERIMENTAL

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

Interventions

Cisplatin 40 mg/m2DRUG

Cisplatin 40 mg/m2, weekly, concurrent with Radiotherapy

Weekly Cisplatin
Cisplatin 100 mg/m2DRUG

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

Three weekly Cisplatin

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biopsy proved, previously untreated, Squamous cell carcinoma of head \& neck
  • Stages III to IVB

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bangabandhu Sheikh Mujib Medical University

Dhaka, 1000, Bangladesh

Location

Related Publications (7)

  • 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.

    PMID: 12506176BACKGROUND

  • 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.

    PMID: 17998687BACKGROUND

  • 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.

    PMID: 27602493BACKGROUND

  • 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.

    PMID: 18607863BACKGROUND

  • 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.

    PMID: 29053029BACKGROUND

  • 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.

    PMID: 26705681BACKGROUND

  • 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.

    PMID: 23245290BACKGROUND

Related Links

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and NeckHead and Neck Neoplasms

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Sarwar Alam, MBBS, Mphil

    Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 22, 2019

First Posted

June 26, 2019

Study Start

July 1, 2017

Primary Completion

June 30, 2018

Study Completion

December 31, 2018

Last Updated

June 28, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Access Criteria
To request an electronic copy send email to dr.iurahim@gmail.com

Locations

BA(1)