Concurrent Chemoradiation Versus Surgery With Adjuvant Therapy in Advanced Laryngopharyngeal Cancers

This study has been terminated.
(Slow Accrual)
Sponsor:
Collaborator:
Department of Science & Technology, Govt. of India
Information provided by (Responsible Party):
Prathamesh S. Pai, Tata Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00128817
First received: August 9, 2005
Last updated: January 21, 2013
Last verified: January 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Tata Memorial Hospital:

Primary Outcome Measures:
  • Overall survival at 3 and 5 years [ Time Frame: 2015 ] [ Designated as safety issue: No ]
  • Disease free survival at 3 and 5 years [ Time Frame: 2015 ] [ Designated as safety issue: No ]
  • Locoregional control rates at 3 and 5 years [ Time Frame: 2015 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patterns of relapse [ Time Frame: 2015 ] [ Designated as safety issue: No ]
  • Salvage rates [ Time Frame: 2015 ] [ Designated as safety issue: No ]
  • Treatment-related adverse events [ Time Frame: 2015 ] [ Designated as safety issue: No ]
  • Completion of treatment [ Time Frame: 2015 ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 2015 ] [ Designated as safety issue: No ]

Estimated Enrollment: 900
Study Start Date: May 2005
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Concurrent Chemoradiation
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
India
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012
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

No publications provided by Tata Memorial Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prathamesh S. Pai, Professor, Tata Memorial Hospital
ClinicalTrials.gov Identifier: NCT00128817     History of Changes
Other Study ID Numbers: TMH/196/2004, DAECTC/Projno 4/2004-2005
Study First Received: August 9, 2005
Last Updated: January 21, 2013
Health Authority: India: Department of Atomic Energy

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

Additional relevant MeSH terms:
Laryngeal Neoplasms
Neoplasms
Head and Neck Neoplasms
Laryngeal Diseases
Neoplasms by Site
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Respiratory Tract Diseases
Respiratory Tract Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014