Combination Chemotherapy Plus Radiation Therapy To Preserve the Larynx in Patients With Cancer of the Hypopharynx or Larynx

NCT00002839 | Completed Phase 3

• 1 other identifier: EORTC-24954
• Study Type: interventional
• Target: 564
• Locations: 6 countries
• Sites: 20

Brief Summary

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

Head and Neck Cancer

Keywords

stage II squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx

Interventions

cisplatin DRUG

fluorouracil DRUG

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (20)

Algemeen Ziekenhuis Middelheim

Antwerp, 2020, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

CHR de Besancon - Hopital Jean Minjoz

Besançon, 25030, France

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Centre Hospitalier Universitaire de Dijon

Dijon, 21033, France

Location

Centre de Lutte Contre le Cancer, Georges-Francois Leclerc

Dijon, 21079, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Hospitalier Regional et Universitaire de Lille

Lille, 59037, France

Location

CRLCC Nantes - Atlantique

Nantes-Saint Herblain, 44805, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Hopital Charles Nicolle

Rouen, 76031, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Istituto Nazionale per lo Studio e la Cura dei Tumori

Milano (Milan), 20133, Italy

Location

Ospedale Civile Monselice

Monselice, Padova, 35043, Italy

Location

Azienda Ospedaliera "Santa Maria Degli Angeli"

Pordenone, 33170, Italy

Location

Vrije Universiteit Medisch Centrum

Amsterdam, 1007 MB, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 CA, Netherlands

Location

Academisch Ziekenhuis Maastricht

Maastricht, 6202 AZ, Netherlands

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Related Publications (3)

• Lefebvre 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 RESULT

• Lefebvre 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.

  RESULT

• Bottomley 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 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Cisplatin; Fluorouracil; Neoadjuvant Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics

Study Officials

• Jean-Louis Lefebvre, MD

  Centre Oscar Lambret

  STUDY CHAIR

• Jean-Claude Horiot, MD, PhD

  Centre Georges Francois Leclerc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: July 1, 1996
• Primary Completion: May 1, 2004
• Last Updated: July 9, 2018

Record last verified: 2018-07

Locations

FR (10); IT (3); CH (1); BE (2); IL (1); NL (3)