Clinical trial · Interventional
Combination Chemotherapy Plus Radiation Therapy To Preserve the Larynx in Patients With Cancer of the Hypopharynx or Larynx
PHASE II STUDY ON LARYNX PRESERVATION COMPARING INDUCTION CHEMOTHERAPY AND RADIOTHERAPY VERSUS ALTERNATING CHEMO-RADIOTHERAPY IN RESECTABLE HYPOPHARYNX AND LARYNX CANCERS
- 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 and allow doctors to preserve the part of the body where the cancer started. It is not yet known which regimen of cisplatin and fluorouracil combined with radiation therapy is more effective in treating resectable cancer of the hypopharynx or larynx. PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of cisplatin and fluorouracil combined with radiation therapy in preserving the larynx in patients who have resectable cancer of the hypopharynx or larynx.
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically proven squamous cell carcinoma of the head and neck, including:
* Stage III/IV cancer of the glottic or supraglottic larynx
* Eligible T4 tumor defined as:
* Bulging the valleculae
* Bulging the hyothyroid membrane
* Minimal thyroid cartilage invasion or suspicion of invasion on imaging
* Stage II/III/IV cancer of the pyriform sinus or of the hypopharyngeal aspect of the aryepiglottic fold (with or without extension to postcricoid area)
* No massive destruction of the thyroid cartilage
* No continuity between primary tumor and a lymph node
* Operable on first attempt (as assessed by head and neck surgeon) by classical total laryngectomy with or without partial pharyngectomy
* No requirement for extended surgery (circumferential pharyngolaryngectomy)
* No tumor suitable for partial (functional) surgery or requiring extended surgery that necessitates any kind of flap for closure
* No N2c tumor unless no requirement for bilateral resection of internal jugular veins
* Measurable or evaluable disease by panendoscopy and CT scan or MRI
* Esophagoscopy required
* Bronchofiberscopy recommended
* No requirement for tracheotomy
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2 OR
* WHO 0-2
Hematopoietic:
* WBC at least 4,000/mm\^3
Hepatic:
* Bilirubin no greater than 2.0 times normal
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 60 mL/min
Other:
* No medical, psychological, or geographical condition that precludes study compliance
* No serious nonmalignant systemic disease
* No second malignancy except:
* Carcinoma in situ of the cervix
* Adequately treated nonmelanomatous skin cancer
* No poor nutritional status unlikely to be restored to fair status within 3 weeks
* No contraindication to CT scan or general anesthesia
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior anticancer biologic therapy
Chemotherapy
* No prior anticancer chemotherapy
Endocrine therapy
* No prior anticancer endocrine therapy
Radiotherapy
* No prior anticancer radiotherapy
Surgery
* See Disease Characteristics
Other
* No other prior anticancer therapyReferences
Publications (3)
- RESULTLefebvre JL, Rolland F, Tesselaar M, Bardet E, Leemans CR, Geoffrois L, Hupperets P, Barzan L, de Raucourt D, Chevalier D, Licitra L, Lunghi F, Stupp R, Lacombe D, Bogaerts J, Horiot JC, Bernier J, Vermorken JB; EORTC Head and Neck Cancer Cooperative Group; EORTC Radiation Oncology Group. Phase 3 randomized trial on larynx preservation comparing sequential vs alternating chemotherapy and radiotherapy. J Natl Cancer Inst. 2009 Feb 4;101(3):142-52. doi: 10.1093/jnci/djn460. Epub 2009 Jan 27. PMID 19176454
- RESULTLefebvre J, Horiot J, Rolland F, et al.: Phase III study on larynx preservation comparing induction chemotherapy and radiotherapy versus alternating chemoradiotherapy in resectable hypopharynx and larynx cancers. EORTC protocol 24954-22950. [Abstract] J Clin Oncol 25 (Suppl 18): A-LBA6016, 303s, 2007.
- DERIVEDBottomley A, Tridello G, Coens C, Rolland F, Tesselaar ME, Leemans CR, Hupperets P, Licitra L, Vermorken JB, Van Den Weyngaert D, Truc G, Barillot I, Lefebvre JL. An international phase 3 trial in head and neck cancer: quality of life and symptom results: EORTC 24954 on behalf of the EORTC Head and Neck and the EORTC Radiation Oncology Group. Cancer. 2014 Feb 1;120(3):390-8. doi: 10.1002/cncr.28392. Epub 2013 Oct 25. PMID 24452673