Concurrent Chemoradiation Versus Surgery With Adjuvant Therapy in Advanced Laryngopharyngeal Cancers

NCT00128817 | Terminated Phase 3 DMC

• 2 other identifiers: TMH/196/2004DAECTC/Projno 4/2004-2005
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

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.

Conditions

Larynx Neoplasms

Keywords

neoplasm; larynx; surgery; radiotherapy; chemotherapy

Outcome Measures

Primary Outcomes (3)

• Overall survival at 3 and 5 years

  2015

• Disease free survival at 3 and 5 years

  2015

• Locoregional control rates at 3 and 5 years

  2015

Secondary Outcomes (5)

• Patterns of relapse

  2015

• Salvage rates

  2015

• Treatment-related adverse events

  2015

• Completion of treatment

  2015

• Quality of life

  2015

Study Arms (2)

1

EXPERIMENTAL

Concurrent Chemoradiation

Radiation: Concurrent Chemoradiation

2

ACTIVE COMPARATOR

Laryngectomy + adjuvant radiotherapy/chemoradiotherapy

Procedure: Laryngectomy + adjuvant radiotherapy/chemoradiotherapy

Interventions

Concurrent Chemoradiation RADIATION

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.

1

Laryngectomy + adjuvant radiotherapy/chemoradiotherapy PROCEDURE

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.

Also known as: Total Laryngectomy, Near-Total Laryngectomy, Adjuvant Radiation Therapy, Adjuvant Chemoradiation

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Tata Memorial Hospital: lead
• Ministry of Science and Technology, India: collaborator

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

Location

Related Publications (1)

• Badwe RA, D'cruz AK, Mistry RC, Tongaonkar HB, Shastri S, Thorat MA. Developing countries: an evolving opportunity for oncologic research. World J Surg. 2006 Jul;30(7):1173-6. doi: 10.1007/s00268-006-0080-y. No abstract available.

  PMID: 16794899 DERIVED

MeSH Terms

Conditions

Laryngeal Neoplasms; Neoplasms; Laryngeal Diseases

Interventions

Laryngectomy; Radiotherapy, Adjuvant; Chemoradiotherapy

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative; Combined Modality Therapy; Therapeutics; Radiotherapy; Drug Therapy

Study Officials

• Prathamesh S Pai, MS,DNB,DORL

  Tata Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 9, 2005
• First Posted: August 10, 2005
• Study Start: May 1, 2005
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: January 23, 2013

Record last verified: 2013-01

Locations

IN (1)