Concurrent Chemoradiation Versus Surgery With Adjuvant Therapy in Advanced Laryngopharyngeal Cancers
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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 |
- 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 ]
- 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:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| India | |
| Tata Memorial Hospital | |
| Mumbai, Maharashtra, India, 400012 | |
| 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:
|
Neoplasms Laryngeal Neoplasms Hypopharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site Laryngeal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms |
Otorhinolaryngologic Diseases Pharyngeal Neoplasms Pharyngeal Diseases Stomatognathic Diseases Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013