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| Sponsors and Collaborators: |
Tata Memorial Hospital Department of Science & Technology, Govt. of India |
| Information provided by: | Tata Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT00128817 |
Purpose
Surgery with post operative radiotherapy (PORT) had been the mainstay of treatment for advanced laryngeal-pharyngeal cancers (ALHC) until the eighth decade of the past century. Total laryngectomy with post-operative radiotherapy (TL + PORT) used to result in permanent tracheostomy and loss of speech.
Early trials like the VA or European Organisation for Research and Treatment of Cancer (EORTC) trials compared surgery with post-operative radiotherapy to induction chemotherapy (ICT) and radiotherapy (RT). Subsequent attempts have been focused on the added benefit of including concurrent chemotherapy. There is no randomized trial available in the literature comparing concurrent chemoradiation with the standard treatment, i.e. surgery followed by radiotherapy. However, most of the studies comparing neoadjuvant chemotherapy and radiotherapy reported better locoregional control rates and better survival rates with surgery followed by post-operative chemotherapy. Further, the advances in primary voice rehabilitation have substantially improved the quality of life after laryngectomy. Thus, there is a strong case for comparing the results of concurrent chemo-radiation with surgery and post-operative radiotherapy in a randomized clinical trial. This trial will answer the question - "whether we are saving voice at the cost of life".
The investigators propose to randomize 900 patients of laryngeal and hypopharyngeal cancers in surgery with PORT and a concomitant chemoradiation arm and compare the survival and locoregional control rates.
| Condition | Intervention | Phase |
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Larynx Neoplasms |
Radiation: Concurrent Chemoradiation Procedure: Laryngectomy + adjuvant radiotherapy/chemoradiotherapy |
Phase III |
| MedlinePlus related topics: | Cancer |
| ChemIDplus related topics: | Cisplatin |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
| Official Title: | Phase III Randomized Clinical Trial to Compare Results of Concurrent Chemo-Radiation With Surgery and Postoperative Radiotherapy/Chemoradiotherapy in Advanced Laryngeal and Hypopharyngeal Cancers |
| Estimated Enrollment: | 900 |
| Study Start Date: | May 2005 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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1: Experimental
Concurrent Chemoradiation
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Radiation: Concurrent Chemoradiation
60-70 Gy at 2Gy/5days a week for 6 to 7 weeks Cisplatin (CDDP) 100 mg/m2 over 20-30 minutes on days 1, 22, and 43.
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2: Active Comparator
Laryngectomy + adjuvant radiotherapy/chemoradiotherapy
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Procedure: Laryngectomy + adjuvant radiotherapy/chemoradiotherapy
Surgery: Total Laryngectomy with or without partial pharyngectomy or Near-Total Laryngectomy with or wothout partial pharyngectomy Adjuvant Radiation 2- 3 weeks following surgery: 50-60Gy at 2Gy/5days a week for 5 to 6 weeks Cisplatin (CDDP) 100 mg/m2 over 20-30 minutes on days 1, 22, and 43.
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Prathamesh S Pai, MS,DNB,DORL | 91-22-2417-7185 | drpai@vsnl.com |
| Contact: Kartik Mohanan | 91-22-2417-7000 ext 4254 | karthik.83@rediffmail.com |
| India, Maharashtra | |||||
| Tata Memorial Hospital | Recruiting | ||||
| Mumbai, Maharashtra, India, 400012 | |||||
| Principal Investigator: Prathamesh S Pai, MS,DNB,DORL | |||||
| Sub-Investigator: Mandar S Deshpande, MS,DNB | |||||
| Tata Memorial Hospital |
| Department of Science & Technology, Govt. of India |
| Principal Investigator: | Prathamesh S Pai, MS,DNB,DORL | Tata Memorial Hospital |
More Information
| Responsible Party: | Tata Memorial Hospital ( Dr. Prathamesh S. Pai ) |
| Study ID Numbers: | TMH/196/2004, DAECTC/Projno 4/2004-2005 |
| First Received: | August 9, 2005 |
| Last Updated: | May 1, 2008 |
| ClinicalTrials.gov Identifier: | NCT00128817 |
| Health Authority: | India: Department of Atomic Energy |
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