Clinical trial · Interventional
Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Larynx or Oropharynx Cancer
A Phase II Trial OF Chemoradiation For Organ Preservation In Resectable Stage III or IV Squamous Cell Carcinomas Of The Larynx Or Oropharynx
NCT00014118CI-TRIAL-00067139completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy and chemotherapy in treating patients who have stage III or stage IV cancer of the larynx or stage III or stage IV cancer of the oropharynx.
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 |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (7)
- measure
- Organ preservation rate
- measure
- Feasibility and toxicity
- measure
- Utility of pre- and post-treatment organ function instruments
- measure
- Disease-free survival and patterns of failure
- measure
- Objective tumor response rate (complete and partial response)
- measure
- Changes in quality of life
- measure
- Correlation of the presence of human papilloma virus infection and p-glycoprotein with outcome
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed stage III or IV (T2-T4) squamous cell carcinoma of the larynx or oropharynx
* No recurrent disease
* No evidence of distant metastasis
* Resectable disease, defined as follows:
* High probability of attaining clear surgical margins (for disease of the base of tongue, tonsil, soft palate, or pharyngeal wall)
* No extension to root of tongue (for disease of the base of tongue)
* No extension into pterygoid by radiograph (for disease of the tonsil, soft palate, or pharyngeal wall)
* No primary tumor or nodal metastases fixed to the carotid artery or cervical spine (for disease of the base of tongue, tonsil, soft palate, or pharyngeal wall)
* No trismus (for disease of the tonsil, soft palate, or pharyngeal wall)
* No involvement of the trachea greater than 1 cm or any involvement of the esophagus (for disease of the subglottis)
* For disease of the supraglottis, glottis, or subglottis:
* No base of the tongue invasion greater than 2 cm
* No tumor extension through cartilage to involve strap muscles of the neck
* No tumor fixation to prevertebral fascia
* No involvement of the carotid artery
* No fixed nodal disease with involvement of the deep neck
* Extension into pyriform sinus or lateral pharyngeal wall allowed if no extension into posterior pharynx
* Measurable disease
* \- Lesions accurately measured in at least one dimension as \> 20 mm (2.0 cm) with conventional techniques or as \> 10 mm (1.0 cm) with spiral CT scan
* Cytologic or histologic evidence of neoplasm is needed for measurable disease restricted to a solitary lesion
* No other concurrent head and neck neoplasms
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Not specified
Renal
* Creatinine less than 3.0 mg/dL
* Calcium normal
Cardiovascular
* No significant cardiac disease
* No uncontrolled hypertension
* No unstable angina
* No congestive heart failure
* No myocardial infarction within the past year
* No serious cardiac arrhythmias requiring medication
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 3 months after study completion
* No significant detectable infection
* No history of allergy to drugs containing Cremophor EL
* No history of allergy to mammalian cell-derived products (epoetin alfa) or human albumin
* No other malignancy within the past 3 years except basal or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy
* No concurrent amifostine
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy above the clavicles
Surgery
* No prior surgery to the primary tumor except biopsy or debulking
Other
* No concurrent experimental mucosal protectantsReferences
Publications (6)
- RESULTFakhry C, Westra WH, Li S, Cmelak A, Ridge JA, Pinto H, Forastiere A, Gillison ML. Improved survival of patients with human papillomavirus-positive head and neck squamous cell carcinoma in a prospective clinical trial. J Natl Cancer Inst. 2008 Feb 20;100(4):261-9. doi: 10.1093/jnci/djn011. Epub 2008 Feb 12. PMID 18270337
- RESULTCmelak AJ, Li S, Goldwasser MA, Murphy B, Cannon M, Pinto H, Rosenthal DI, Gillison M, Forastiere AA. Phase II trial of chemoradiation for organ preservation in resectable stage III or IV squamous cell carcinomas of the larynx or oropharynx: results of Eastern Cooperative Oncology Group Study E2399. J Clin Oncol. 2007 Sep 1;25(25):3971-7. doi: 10.1200/JCO.2007.10.8951. PMID 17761982
- RESULTFakhry C, Westra W, Li S, et al.: Prognostic significance of human papillomavirus (HPV) tumor status for patients with head and neck squamous cell carcinoma (HNSCC) in a prospective, multi-center phase II clinical trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-6000, 299s, 2007.
- RESULTCmelak AJ, Li S, Murphy B, et al.: Locally advanced resectable larynx (L) or oropharynx (OP) cancer: updated results of organ preservation trial ECOG 2399. [Abstract] J Clin Oncol 24 (Suppl 18): A-5527, 286s, 2006.
- RESULTMurphy BA, Smith K, Cmelak A, et al.: Swallowing function for patients treated on E2399: a phase II trial of function preservation with induction paclitaxel/carboplatin followed by radiation plus weekly paclitaxel. [Abstract] J Clin Oncol 24 (Suppl 18): A-5524, 2006.
- RESULTMurphy BA, Smith K, Dowling E, et al.: Baseline swallowing function for patients treated on E2399: a phase II trial of function preservation with induction paclitaxel/carboplatin followed by radiation plus weekly paclitaxel. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2005, 2003.