Head and Neck CancerPhase 3NCT00002555
High-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer
A Phase 3 study testing cisplatin, low-LET cobalt-60 gamma ray therapy and low-LET electron therapy in people with Head and Neck Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 19 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- cisplatin, low-LET cobalt-60 gamma ray therapy and low-LET electron therapy
- Type of treatment
- Surgery or procedure
- How many people
- 338 participants
- Where
- 19 sitesin 10 countries
- Study dates
- Feb 1994to Oct 2000
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the head and neck of the following sites: Oral cavity Oropharynx Hypopharynx (only if ineligible for protocol EORTC-24891) Larynx T3-4, any N, M0 or any T, N2-3, M0 disease (UICC staging) resected with curative intent T3, N0 carcinoma of the larynx with suitable microscopically clear margins is ineligible At least one of the following high-risk characteristics required: Histopathologically positive surgical margins No gross residual disease Perineural involvement Extranodal spread of disease Oral cavity or oropharyngeal lesions with metastatic nodes at level 4 or 5 Vascular embolisms in the neck No metastases at diagnosis No known CNS disease
PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: WHO 0-2 Hematopoietic: WBC at least 4,000 Platelets at least 100,000 Hemoglobin normal (at least 6.8 mmoles/liter) Hepatic: Bilirubin no greater than 2 times normal Other liver function tests no greater than 2 times normal Renal: Creatinine no greater than 1.3 mg/dL (120 micromoles/liter) Creatinine clearance greater than 60 mL/min Other: No active, uncontrolled infection No requirement for antibiotics that might interfere with platinum excretion No requirement for drugs affecting bone marrow function (e.g., lithium, corticosteroids) No medical condition precluding postoperative chemotherapy No prior or concurrent malignancy other than nonmelanomatous skin cancer
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior locoregional radiotherapy to the head and neck Surgery: Excision with curative intent required
Trial locations and contacts
19 sites in 10 countries.
19 sites in 10 countries
France6 sites
Centre de Lute Contre le Cancer,Georges-Francois Leclerc
Dijon, 21079
CHR de Grenoble - La Tronche
Grenoble, 38043
Centre Oscar Lambret
Lille, 59020
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, 44805
Hopital Jean Bernard
Poitiers, 86021
Institut Gustave Roussy
Villejuif, F-94805
Switzerland4 sites
Ospedale San Giovanni
Bellinzona, CH-6500
Inselspital, Bern
Bern, CH-3010
Centre Hospitalier Universitaire Vaudois
Lausanne, CH-1011
Universitaetsspital
Zurich, CH-8091
Italy2 sites
Istituto Nazionale per lo Studio e la Cura dei Tumori
Milan, 20133
Istituti Fisioterapici Ospitalieri - Roma
Rome, 00161
Turkey (Türkiye)1 site
Dokuz Eylul University School of Medicine
Izmir, 35340
United Kingdom1 site
Nottingham City Hospital NHS Trust
Nottingham, England, NG5 1PB
About this study
Official title: A PHASE III RANDOMIZED STUDY ON POSTOPERATIVE RADIO- AND CHEMOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED HEAD AND NECK CARCINOMAS
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 head and neck cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of high-dose radiation therapy alone with high-dose radiation therapy plus cisplatin in treating patients with head and neck cancer who have undergone surgery to remove the cancer.
Read the detailed description
OBJECTIVES: I. Determine whether the addition of cisplatin to high-dose postoperative radiotherapy increases the disease-free survival rate of patients with locally advanced head and neck carcinomas at high risk of recurrence following radical surgery.
OUTLINE: Randomized study. Patients are registered and randomized to treatment within 25 days of surgery. Arm I: Radiotherapy. Irradiation of the preoperative primary tumor site with a boost to areas at high risk for recurrence using Co60 equipment, 4-6 MV linear accelerators, or 6-12 MeV electrons. Arm II: Radiotherapy plus Single-Agent Chemotherapy. Irradiation as in Arm I; plus Cisplatin, CDDP, NSC-119875.
PROJECTED ACCRUAL: A total of 338 evaluable patients will be studied.
- Conditions
- Head and Neck Cancer
- Being tested
- cisplatin, low-LET cobalt-60 gamma ray therapy, low-LET electron therapy, low-LET photon therapy
- 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
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
low-LET cobalt-60 gamma ray therapyRadiation
low-LET electron therapyRadiation
low-LET photon therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2004 (estimated)
- Study startFeb 1994
- Primary completionOct 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 338 participants (estimated)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jacques Bernier, MD, PhD, Study chair, Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002555
- Sponsor's protocol ID
- EORTC-22931
- Other IDs
- EORTC-22931
- Status last verified
- Jun 2012
- First submitted
- 1 Nov 1999
- Last updated
- 2 Jul 2012
- Results posted
- No
Publications
Bernier J, Cooper JS, Pajak TF, van Glabbeke M, Bourhis J, Forastiere A, Ozsahin EM, Jacobs JR, Jassem J, Ang KK, Lefebvre JL. Defining risk levels in locally advanced head and neck cancers: a comparative analysis of concurrent postoperative radiation plus chemotherapy trials of the EORTC (#22931) and RTOG (# 9501). Head Neck. 2005 Oct;27(10):843-50. doi: 10.1002/hed.20279.
PubMed 16161069Bernier J, Domenge C, Ozsahin M, Matuszewska K, Lefebvre JL, Greiner RH, Giralt J, Maingon P, Rolland F, Bolla M, Cognetti F, Bourhis J, Kirkpatrick A, van Glabbeke M; European Organization for Research and Treatment of Cancer Trial 22931. Postoperative irradiation with or without concomitant chemotherapy for locally advanced head and neck cancer. N Engl J Med. 2004 May 6;350(19):1945-52. doi: 10.1056/NEJMoa032641.
PubMed 15128894Bernier J, Domenge C, Eschwege F, et al.: Chemo-radiotherapy, as compared to radiotherapy alone, significantly increases disease-free and overall survival in head and neck cancer patients after surgery: results of EORTC phase III trial 22931. [Abstract] Int J Radiat Oncol Biol Phys 51(3 suppl 1): A-1, 1, 2001.
Valley JF, Bernier J, Tercier PA, Fogliata-Cozzi A, Rosset A, Garavaglia G, Mirimanoff RO. Quality assurance of the EORTC radiotherapy trial 22931 for head and neck carcinomas: the dummy run. Radiother Oncol. 1998 Apr;47(1):37-44. doi: 10.1016/s0167-8140(97)00218-1.
PubMed 9632290
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE III RANDOMIZED STUDY ON POSTOPERATIVE RADIO- AND CHEMOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED HEAD AND NECK CARCINOMAS
- ClinicalTrials.gov ID
- NCT00002555
- Acronym / sponsor ID
- EORTC-22931
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 338 participants (estimated)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Feb 1994
- Primary completion
- Oct 2000 (actual)
- First posted
- 26 May 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 head and neck cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of high-dose radiation therapy alone with high-dose radiation therapy plus cisplatin in treating patients with head and neck cancer who have undergone surgery to remove the cancer.
Detailed description
OBJECTIVES: I. Determine whether the addition of cisplatin to high-dose postoperative radiotherapy increases the disease-free survival rate of patients with locally advanced head and neck carcinomas at high risk of recurrence following radical surgery.
OUTLINE: Randomized study. Patients are registered and randomized to treatment within 25 days of surgery. Arm I: Radiotherapy. Irradiation of the preoperative primary tumor site with a boost to areas at high risk for recurrence using Co60 equipment, 4-6 MV linear accelerators, or 6-12 MeV electrons. Arm II: Radiotherapy plus Single-Agent Chemotherapy. Irradiation as in Arm I; plus Cisplatin, CDDP, NSC-119875.
PROJECTED ACCRUAL: A total of 338 evaluable patients will be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cisplatin | Drug | – |
| low-LET cobalt-60 gamma ray therapy | Radiation | – |
| low-LET electron therapy | Radiation | – |
| low-LET photon therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2012.
- Results publication: PubMed 16161069Bernier J, Cooper JS, Pajak TF, van Glabbeke M, Bourhis J, Forastiere A, Ozsahin EM, Jacobs JR, Jassem J, Ang KK, Lefebvre JL. Defining risk levels in locally advanced head and neck cancers: a comparative analysis of concurrent postoperative radiation plus chemotherapy trials of the EORTC (#22931) and RTOG (# 9501). Head Neck. 2005 Oct;27(10):843-50. doi: 10.1002/hed.20279.
- Results publication: PubMed 15128894Bernier J, Domenge C, Ozsahin M, Matuszewska K, Lefebvre JL, Greiner RH, Giralt J, Maingon P, Rolland F, Bolla M, Cognetti F, Bourhis J, Kirkpatrick A, van Glabbeke M; European Organization for Research and Treatment of Cancer Trial 22931. Postoperative irradiation with or without concomitant chemotherapy for locally advanced head and neck cancer. N Engl J Med. 2004 May 6;350(19):1945-52. doi: 10.1056/NEJMoa032641.
- Results publicationBernier J, Domenge C, Eschwege F, et al.: Chemo-radiotherapy, as compared to radiotherapy alone, significantly increases disease-free and overall survival in head and neck cancer patients after surgery: results of EORTC phase III trial 22931. [Abstract] Int J Radiat Oncol Biol Phys 51(3 suppl 1): A-1, 1, 2001.
- Results publication: PubMed 9632290Valley JF, Bernier J, Tercier PA, Fogliata-Cozzi A, Rosset A, Garavaglia G, Mirimanoff RO. Quality assurance of the EORTC radiotherapy trial 22931 for head and neck carcinomas: the dummy run. Radiother Oncol. 1998 Apr;47(1):37-44. doi: 10.1016/s0167-8140(97)00218-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques Bernier, MD, PhD study chair
Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
19 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cisplatin, low-LET cobalt-60 gamma ray therapy and low-LET electron therapy in people with Head and Neck Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 19 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France, Switzerland, Italy, Belgium, Netherlands and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002555, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2012.