Status:
TERMINATED
Concurrent Chemoradiation Versus Surgery With Adjuvant Therapy in Advanced Laryngopharyngeal Cancers
Lead Sponsor:
Tata Memorial Hospital
Collaborating Sponsors:
Ministry of Science and Technology, India
Conditions:
Larynx Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
TL + PORT has traditionally been the gold standard in management of ALHC. However, this results in permanent tracheostomy and a possible loss of speech. In case of partial laryngectomy and even in cas...
Eligibility Criteria
Inclusion
- Patients with biopsy-proven, previously untreated, T3/T4 tumors (with focal cartilage erosion on computed tomography \[CT\] scan); squamous cell carcinoma of larynx and hypopharynx.
- Patients with Karnofsky Performance Scale (KPS) \> 80
- Patients must have resectable tumors which are potentially curable with conventional surgery and radiation therapy.
- Willing to participate in trial and get randomized
Exclusion
- Gross cartilage invasion
- Extensive soft tissue infiltration
- Large nodal disease
- Distant metastases
- Synchronous primary
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2015
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT00128817
Start Date
May 1 2005
End Date
May 1 2015
Last Update
January 23 2013
Active Locations (1)
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1
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012