Radiation Therapy With or Without Cisplatin in Treating Patients With Advanced Head and Neck Cancer

NCT00002654 | Completed Phase 3

• 4 other identifiers: SAKK 10/94SWS-SAKK-10/94EU-94039CDR0000064188
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy plus chemotherapy is more effective than radiation therapy alone in treating patients with advanced head and neck cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus cisplatin with radiation therapy alone in treating patients with advanced head and neck cancer.

Conditions

Head and Neck Cancer

Keywords

stage III squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; 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

chemotherapy DRUG

cisplatin DRUG

low-LET cobalt-60 gamma ray therapy RADIATION

low-LET electron therapy RADIATION

low-LET photon therapy RADIATION

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically documented squamous cell cancer of the head and neck in the following sites: Hypopharynx Larynx Oral cavity Oropharynx Stage III/IV disease No distant metastases by the following: Chest x-ray (all patients) Liver ultrasound or CT and bone scintigraphy (all hypopharyngeal cancers, those with involved lower neck nodes, and as clinically indicated) Multiple sites of disease eligible provided radiotherapy treatment volume remains acceptable PATIENT CHARACTERISTICS: Age: 20 to 75 Performance status: WHO 0-2 Hematopoietic: WBC greater than 3,000 Platelets greater than 100,000 Hepatic: Not specified Renal: Creatinine clearance at least 60 ml/min No renal disease or impairment of renal function Cardiovascular: No coronary heart disease No cardiac failure No history of pulmonary embolism within 2 years Other: No clinical hearing impairment No peripheral neuropathy with concomitant handicap No severe diabetes mellitus with serious vasculopathy or neuropathy No second cancer except: Nonmelanomatous skin or lip cancer In situ carcinoma of the cervix Blood/body fluid analyses to determine eligibility completed within 14 days prior to registration PRIOR CONCURRENT THERAPY: No prior treatment for head and neck cancer Excisional biopsy for diagnosis allowed

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

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (1)

Universitaetsspital

Zurich, CH-8091, Switzerland

Location

Related Publications (7)

• Ghadjar P, Simcock M, Studer G, Allal AS, Ozsahin M, Bernier J, Topfer M, Zimmermann F, Betz M, Glanzmann C, Aebersold DM; Swiss Group for Clinical Cancer Research (SAKK). Concomitant cisplatin and hyperfractionated radiotherapy in locally advanced head and neck cancer: 10-year follow-up of a randomized phase III trial (SAKK 10/94). Int J Radiat Oncol Biol Phys. 2012 Feb 1;82(2):524-31. doi: 10.1016/j.ijrobp.2010.11.067. Epub 2011 Feb 16.

  PMID: 21300466 RESULT

• Taussky D, Rufibach K, Huguenin P, Allal AS. Risk factors for developing a second upper aerodigestive cancer after radiotherapy with or without chemotherapy in patients with head-and-neck cancers: an exploratory outcomes analysis. Int J Radiat Oncol Biol Phys. 2005 Jul 1;62(3):684-9. doi: 10.1016/j.ijrobp.2004.11.027.

  PMID: 15936546 RESULT

• Huguenin P, Beer KT, Allal A, Rufibach K, Friedli C, Davis JB, Pestalozzi B, Schmid S, Thoni A, Ozsahin M, Bernier J, Topfer M, Kann R, Meier UR, Thum P, Bieri S, Notter M, Lombriser N, Glanzmann C. Concomitant cisplatin significantly improves locoregional control in advanced head and neck cancers treated with hyperfractionated radiotherapy. J Clin Oncol. 2004 Dec 1;22(23):4665-73. doi: 10.1200/JCO.2004.12.193. Epub 2004 Nov 8.

  PMID: 15534360 RESULT

• Ghadjar P, Simcock M, Zimmermann F, Betz M, Bodis S, Bernier J, Studer G, Aebersold DM; Swiss Group for Clinical Cancer Research (SAKK). Predictors of severe late radiotherapy-related toxicity after hyperfractionated radiotherapy with or without concomitant cisplatin in locally advanced head and neck cancer. Secondary retrospective analysis of a randomized phase III trial (SAKK 10/94). Radiother Oncol. 2012 Aug;104(2):213-8. doi: 10.1016/j.radonc.2012.05.004. Epub 2012 Jun 21.

  PMID: 22726581 RESULT

• Ghadjar P, Pottgen C, Joos D, Hayoz S, Baumann M, Bodis S, Budach W, Studer G, Stromberger C, Zimmermann F, Kaul D, Plasswilm L, Olze H, Bernier J, Wust P, Aebersold DM, Budach V. Haemoglobin and creatinine values as prognostic factors for outcome of concurrent radiochemotherapy in locally advanced head and neck cancers : Secondary results of two European randomized phase III trials (ARO 95-06, SAKK 10/94). Strahlenther Onkol. 2016 Aug;192(8):552-60. doi: 10.1007/s00066-016-0999-3. Epub 2016 Jun 20.

  PMID: 27323753 RESULT

• Ghadjar P, Hayoz S, Zimmermann F, Bodis S, Kaul D, Badakhshi H, Bernier J, Studer G, Plasswilm L, Budach V, Aebersold DM; Swiss Group for Clinical Cancer Research (SAKK). Impact of weight loss on survival after chemoradiation for locally advanced head and neck cancer: secondary results of a randomized phase III trial (SAKK 10/94). Radiat Oncol. 2015 Jan 17;10:21. doi: 10.1186/s13014-014-0319-y.

  PMID: 25679310 RESULT

• Ghadjar P, Sun H, Zimmermann F, Bodis S, Bernier J, Studer G, Aebersold DM; Swiss Group for Clinical Cancer Research (SAKK). Physical examination during chemoradiation predicts outcome of locally advanced head and neck cancer. Secondary results of a randomized phase III trial (SAKK 10/94). Oral Oncol. 2013 Oct;49(10):1006-9. doi: 10.1016/j.oraloncology.2013.07.002. Epub 2013 Aug 3.

  PMID: 23916716 RESULT

MeSH Terms

Conditions

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

Interventions

Drug Therapy; Cisplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Pia Huguenin, MD

  UniversitaetsSpital Zuerich

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: July 1, 2004
• Study Start: April 1, 1994
• Primary Completion: March 1, 1999
• Study Completion: July 1, 2000
• Last Updated: May 15, 2019

Record last verified: 2019-05

Locations

CH (1)