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)
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|ClinicalTrials.gov Identifier: NCT03998696|
Recruitment Status : Completed
First Posted : June 26, 2019
Last Update Posted : June 28, 2019
|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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03998696
|Bangabandhu Sheikh Mujib Medical University|
|Dhaka, Bangladesh, 1000|
|Study Chair:||Sarwar Alam, MBBS, Mphil||Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh|