ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Concurrent Chemoradiation Versus Surgery With Adjuvant Therapy in Advanced Laryngopharyngeal Cancers

This study is currently recruiting participants.
Verified by Tata Memorial Hospital, April 2008

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
Larynx Neoplasms
Radiation: Concurrent Chemoradiation
Procedure: Laryngectomy + adjuvant radiotherapy/chemoradiotherapy
Phase III

MedlinePlus related topics:   Cancer   

ChemIDplus related topics:   Cisplatin   

U.S. FDA Resources

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

Further study details as provided by Tata Memorial Hospital:

Primary Outcome Measures:
  • Overall survival at 3 and 5 years
  • Disease free survival at 3 and 5 years
  • Locoregional control rates at 3 and 5 years

Secondary Outcome Measures:
  • Patterns of relapse
  • Salvage rates
  • Treatment-related adverse events
  • Completion of treatment
  • Quality of life

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
1: Experimental
Concurrent Chemoradiation
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.
2: Active Comparator
Laryngectomy + adjuvant radiotherapy/chemoradiotherapy
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.

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • 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 Criteria:

  • Gross cartilage invasion
  • Extensive soft tissue infiltration
  • Large nodal disease
  • Distant metastases
  • Synchronous primary
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00128817

Contacts
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    

Locations
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            

Sponsors and Collaborators
Tata Memorial Hospital
Department of Science & Technology, Govt. of India

Investigators
Principal Investigator:     Prathamesh S Pai, MS,DNB,DORL     Tata Memorial Hospital    
  More Information

Publications indexed to this study:

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

Keywords provided by Tata Memorial Hospital:
neoplasm  
larynx  
surgery  
radiotherapy  
chemotherapy  

Study placed in the following topic categories:
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Cisplatin
Respiratory Tract Diseases
Head and Neck Neoplasms
Laryngeal carcinoma
Hypopharyngeal cancer
Laryngeal Neoplasms
Laryngeal Diseases

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on September 05, 2008




Links to all studies - primarily for crawlers