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Concurrent Chemoradiation Versus Surgery With Adjuvant Therapy in Advanced Laryngopharyngeal Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00128817
Recruitment Status : Terminated (Slow Accrual)
First Posted : August 10, 2005
Last Update Posted : January 23, 2013
Ministry of Science and Technology, India
Information provided by (Responsible Party):
Prathamesh S. Pai, Tata Memorial Hospital

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 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 or disease Intervention/treatment Phase
Larynx Neoplasms Radiation: Concurrent Chemoradiation Procedure: Laryngectomy + adjuvant radiotherapy/chemoradiotherapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2005
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
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.

Active Comparator: 2
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.
Other Names:
  • Total Laryngectomy
  • Near-Total Laryngectomy
  • Adjuvant Radiation Therapy
  • Adjuvant Chemoradiation

Primary Outcome Measures :
  1. Overall survival at 3 and 5 years [ Time Frame: 2015 ]
  2. Disease free survival at 3 and 5 years [ Time Frame: 2015 ]
  3. Locoregional control rates at 3 and 5 years [ Time Frame: 2015 ]

Secondary Outcome Measures :
  1. Patterns of relapse [ Time Frame: 2015 ]
  2. Salvage rates [ Time Frame: 2015 ]
  3. Treatment-related adverse events [ Time Frame: 2015 ]
  4. Completion of treatment [ Time Frame: 2015 ]
  5. Quality of life [ Time Frame: 2015 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00128817

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Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012
Sponsors and Collaborators
Tata Memorial Hospital
Ministry of Science and Technology, India
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Principal Investigator: Prathamesh S Pai, MS,DNB,DORL Tata Memorial Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prathamesh S. Pai, Professor, Tata Memorial Hospital Identifier: NCT00128817    
Other Study ID Numbers: TMH/196/2004
DAECTC/Projno 4/2004-2005
First Posted: August 10, 2005    Key Record Dates
Last Update Posted: January 23, 2013
Last Verified: January 2013
Keywords provided by Prathamesh S. Pai, Tata Memorial Hospital:
Additional relevant MeSH terms:
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Laryngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases