Home » Trials » SLCTR/2014/019
The comparison of toxicity between weekly and three weekly Cisplatin infusion in chemoradiation for squamous cell carcinoma of head and neck
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SLCTR Registration Number
SLCTR/2014/019
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
The comparison of toxicity between weekly and three weekly Cisplatin infusion in chemoradiation for squamous cell carcinoma of head and neck
Public Title of Trial
The comparison between two Cisplatin doses for squamous cell carcinoma of head and neck
Disease or Health Condition(s) Studied
Squamous cell carcinoma of head and neck
Scientific Acronym
None
Public Acronym
None
Brief title
The comparison of toxicity between weekly and three weekly Cisplatin infusion in chemoradiation for squamous cell carcinoma of head and neck
Universal Trial Number
U1111-1160-0048
Any other number(s) assigned to the trial and issuing authority
ERC/13-042 (Sri Lanka Medical Association)
What is the research question being addressed?
What are the toxic effects of weekly (low dose) Cisplatin infusion compared to three weekly (high dose) Cisplatin infusion in chemoradiation for squamous cell carcinoma of head and neck?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Dose comparison
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
Consenting patients meeting inclusion/exclusion criteria will be randomized into two arms.
Participants in the low-dose Cisplatin arm (arm 1) will receive Cisplatin at 40 mg/m2 once per week for 6 cycles
Participants in the high-dose Cisplatin arm (arm 2) will be treated with Cisplatin at 80 mg/m2 once every 3 weeks on 1st or 2nd day of starting radiotherapy for 3 cycles
Radiotherapy will be administered using 6 MV X rays or Cobalt 60 beams at a conventional fractionation dose of 2 Gy/fraction/day and 5 days per week by two dimensional conventional technique or three dimensional conformal technique(3DCRT). All patients will be irradiated with a total dose of 66 Gy or 70Gy.
Inclusion criteria
Male and female patients between 18-70 years of age
Histologically confirmed squamous cell carcinoma of head and neck who need chemoradiation
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Fitness for chemoradiotherapy as determined by detailed history, a clinical examination and following investigations ie: (i). Full Blood Count (ii) Serum creatinine (iii) 24 hour creatinine clearance test (iv) Urine full report (v) Ultrasound assessment of kidneys, bladder, ureter and liver (vi) Echo cardiogram (vii) Serum Magnesium (viii) Chest X ray
Exclusion criteria
Primary outcome(s)
|
1.
Toxicity of the therapy (according to the WHO Grading System in “Toxicity Criteria”. Myelosupression, mucositis, renal toxicity, skin reactions and hearing defect, peripheral sensory loss will be assessed as the indicators of toxicity). |
[ Weekly in all arms, until the treatment is complete. ] |
Secondary outcome(s)
|
1.
Body weight |
[ Weekly in all arms, until the treatment is complete. ] |
Target number/sample size
470 (235 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2014-09-22
Anticipated end date
2015-07-31
Date of first enrollment
2014-09-22
Date of study completion
Recruitment status
Recruiting
Funding source
Self funding
Regulatory approvals
Status
Approved
Date of Approval
2014-06-20
Approval number
ERC/13-042
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Sri Lanka Medical Association |
| Institutional Address: | No 6, Wijerama Mawatha, Colombo 00700 Sri Lanka |
| Telephone: | +94-11-2693324 |
| Email: | erc.slma@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. S. P. Weerasinghe
Consultant Clinical Oncologist
National Cancer Institute, Maharagama
0112850252
0714420711
gallagemaheel@hotmail.com
Contact Person for Public Queries
Dr. S. P. Weerasinghe
Consultant Clinical Oncologist
National Cancer Institute, Maharagama
0112850252
0714420711
gallagemaheel@hotmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
