Clinical trial · Interventional
Concurrent Chemoradiation Versus Surgery With Adjuvant Therapy in Advanced Laryngopharyngeal Cancers
Phase III Randomized Clinical Trial to Compare Results of Concurrent Chemo-radiation With Surgery and Postoperative Radiotherapy/Chemoradiotherapy in Advanced Laryngeal and Hypopharyngeal Cancers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow Accrual
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Larynx Neoplasms | Laryngeal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Concurrent Chemoradiation | Radiation | — | UNRESOLVED |
| Laryngectomy + adjuvant radiotherapy/chemoradiotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Concurrent Chemoradiation
- interventionNames
- Radiation: Concurrent Chemoradiation
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Laryngectomy + adjuvant radiotherapy/chemoradiotherapy
- interventionNames
- Procedure: Laryngectomy + adjuvant radiotherapy/chemoradiotherapy
Primary outcomes (3)
- measure
- Overall survival at 3 and 5 years
- timeFrame
- 2015
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBadwe 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