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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00012877 |
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Date of registration:
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16/08/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Comparison of Response and Acute Toxicities of Concurrent Chemoradiation with Weekly Cisplatin Vs. Paclitaxel/Carboplatin in Locally Advanced Squamous Cell Carcinoma of Head & Neck: A Short-term Phase III Clinical Trial.
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Scientific title:
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Comparison of Response and Acute Toxicities of Concurrent Chemoradiation with Weekly Cisplatin Vs. Paclitaxel/Carboplatin in Locally Advanced Squamous Cell Carcinoma of Head & Neck: A Short-term Phase III Clinical Trial. - Shuayb HN CCRT Trial |
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Date of first enrolment:
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30/09/2017 |
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Target sample size:
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100 |
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Recruitment status: |
Pending |
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URL:
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http://drks.de/search/en/trial/DRKS00012877 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: treatment
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Phase:
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2-3
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Countries of recruitment
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Bangladesh
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Contacts
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Name:
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Md
Shuayb |
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Address:
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18/F, West Panthapath, Dhaka-1205
1205
Dhaka
Bangladesh |
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Telephone:
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+8801553139179 |
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Email:
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drshuayb@squarehospital.com |
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Affiliation:
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Dr. Md Shuayb, MBBS, MSc, FCPS, Specialist, Oncology & Radiotherapy Centre, Square Hospitals Ltd. |
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Name:
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Md
Shuayb |
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Address:
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18/F, West Panthapath, Dhaka-1205
1205
Dhaka
Bangladesh |
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Telephone:
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+8801553139179 |
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Email:
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drshuayb@squarehospital.com |
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Affiliation:
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Dr. Md Shuayb, MBBS, MSc, FCPS, Specialist, Oncology & Radiotherapy Centre, Square Hospitals Ltd. |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1) SCCHN proved by histopathology.
2) AJCC stage-III, IVA and IVB.
3) Age: 18 to 75.
4) Eastern Cooperative Oncology Group (ECOG) performance status = 2.
5) Biochemical tests values: WBC= 3.5×10^9/L, Neutrophils =1.5×10^9/L, Platelets =100×10^9/L, haemoglobin =9gm/dl, Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin =1.5×the upper limit of the institutional normal range, Creatinine concentration=120 umol/L, and creatinine clearance =50 ml/min.
6) No serious diseases of important organs.
7) Written informed consent signed prior to enrollment.
Exclusion criteria: 1) Prior chemotherapy or head & neck irradiation,
2) Pregnant or lactating woman,
3) Serious diseases (include significant cardiovascular disease or uncontrolled diabetes) of important organs,
4) Other malignancies,
5) Active uncontrolled infection,
6) Joined in other clinical trial,
7) Stage IVB with cricoid cartilage invasion.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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C76.0
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C76.0
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Head, face and neck
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Intervention(s)
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Group 1: Concurrent chemoradiotherapy regimens with CDDP (cisplatin 30mg/m² weekly with premedications and adequate hydration; radiotherapy- 6600-7000 cGy in single daily 1.8-2 Gy/fraction, 5 days a week on linear accelerator with 4 or 6 MV photon beams)
Group 2: Concurrent chemoradiotherapy regimens with PC (paclitaxel 40mg/m² over 1 hour followed by carboplatin AUC-2 over 30 min with premedications, weekly; radiotherapy- 6600-7000 cGy in single daily 1.8-2 Gy/fraction, 5 days a week on linear accelerator with 4 or 6 MV photon beams)
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Primary Outcome(s)
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What: Treatment Response
When: 6 weeks after completion of Treatment
How: The treatment response evaluation will be performed according to the Response Evaluation Criteria in Solid Tumours (RECIST), version 1.1 as Complete response (CR), partial response (PR), progressive disease (PD), stable disease (SD) using the data of Panendoscopic evaluation and CT scans of neck & face obtained 6 weeks after therapy. Pathologic confirmation will be required for patients suspected to have clinical evidence of residual disease at the primary site 6 weeks after therapy.
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Secondary Outcome(s)
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What: Acute toxicities
When: Weekly during treatment and 6 weeks after completion of treatment.
How: Acute toxicities of the two regimens will be evaluated by determining the frequency of severe (= grade 3) toxicities based on RTOG Acute Radiation Morbidity Criteria using the information of history and physical examinations, ECOG performance status, CBC, electrolyte, creatinine, SGPT.
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Source(s) of Monetary Support
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National Institute of Cancer Research & Hospital (NICRH)
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Ethics review
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Status: Approved
Approval date: 22/07/2015
Contact:
National Institute of Cancer Research and HospitalEthics Committee [Ethical Committee, National Institute of Cancer Research & Hospital (NICRH)]
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