Head and Neck CancerPhase 3NCT00002747
Surgery and Radiation Therapy With or Without Chemotherapy in Treating Patients With Mouth Cancer
A Phase 3 study testing cisplatin, fluorouracil and conventional surgery in people with Head and Neck Cancer, run by European Institute of Oncology at 1 site in Italy.
Trial 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. It is not yet known if surgery plus radiation therapy is more effective with or without chemotherapy for treating mouth cancer. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- cisplatin, fluorouracil and conventional surgery
- Type of treatment
- Surgery or procedure
- How many people
- 240 participants
- Where
- 1 siteItaly
- Study dates
- Sep 1992to not given
- 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 Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS: Squamous cell carcinoma of the lower oral cavity eligible for resection T2 (greater than 3 cm), T3, or T4, and N0-3 M0 (UICC staging system) No requirement for postsurgical reconstruction that would impede further radiotherapy
PATIENT CHARACTERISTICS: Age: 70 and under Performance status: WHO 0 or 1 Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil count at least 2,000/mm3 Platelet count at least 110,000/mm3 Hepatic: Not specified Renal: Creatinine no greater than 1.3 mg/dL Creatinine clearance at least 50 mg/mL BUN no greater than 50 mg/dL Cardiovascular: No cardiopathy Other: No significant internal disease No prior malignancy except basal cell carcinoma of the skin No geographic barrier to treatment
PRIOR CONCURRENT THERAPY: No prior therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RANDOMIZED TRIAL OF NEOADJUVANT CHEMOTHERAPY AND SURGERY +/- RADIOTHERAPY VERSUS SURGEERY +/- RADIOTHERAPY IN OPERABLE SQUAMOUS CELL CARCINOMA OF THE ORAL CAVITY
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. It is not yet known if surgery plus radiation therapy is more effective with or without chemotherapy for treating mouth cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of surgery and radiation therapy with or without chemotherapy in treating patients with stage II, stage III, or stage IV mouth cancer.
Read the detailed description
OBJECTIVES: I. Assess the short- and long-term local control rates, disease-free survival, and overall survival following treatment with neoadjuvant cisplatin plus fluorouracil followed by surgery with or without radiotherapy vs surgery alone with or without radiotherapy in patients with previously untreated stage II-IV squamous cell carcinoma of the oral cavity. II. Assess the prognostic significance of clinical and pathologic responses to neoadjuvant chemotherapy in these patients. III. Compare the short- and long-term toxic effects of these two regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by center and nodal status (N0 vs N1-2 vs N3). Patients are randomized to one of two treatment arms. Arm I: Patients receive cisplatin IV on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable disease after 2 courses or progressive disease at any time proceed to surgery. Patients undergo resection of the primary tumor site and possible nodal dissection no sooner than 2 weeks after completion of chemotherapy. Patients then undergo radiotherapy over 5-6 weeks no later than 8 weeks after surgery. Arm II: Patients undergo surgery and radiotherapy as in arm I. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then yearly thereafter.
PROJECTED ACCRUAL: A total of 240 patients will be accrued for this study over 9 years.
- Conditions
- Head and Neck Cancer
- Being tested
- cisplatin, fluorouracil, conventional surgery, low-LET cobalt-60 gamma ray therapy, low-LET photon therapy
- Keywords
- stage II squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
fluorouracilDrug
conventional surgeryProcedure or surgery
low-LET cobalt-60 gamma ray 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 posted23 Jun 2004 (estimated)
- Study startSep 1992
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe 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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Investigators
- R. Molinari, MD, Study chair, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002747
- Sponsor's protocol ID
- CDR0000064678
- Other IDs
- CNR-012309
- Status last verified
- May 2007
- First submitted
- 1 Nov 1999
- Last updated
- 20 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RANDOMIZED TRIAL OF NEOADJUVANT CHEMOTHERAPY AND SURGERY +/- RADIOTHERAPY VERSUS SURGEERY +/- RADIOTHERAPY IN OPERABLE SQUAMOUS CELL CARCINOMA OF THE ORAL CAVITY
- ClinicalTrials.gov ID
- NCT00002747
- Acronym / sponsor ID
- CDR0000064678
- Conditions
- Head and Neck Cancer
- Keywords
- stage II squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- Sep 1992
- First posted
- 23 Jun 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: 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. It is not yet known if surgery plus radiation therapy is more effective with or without chemotherapy for treating mouth cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of surgery and radiation therapy with or without chemotherapy in treating patients with stage II, stage III, or stage IV mouth cancer.
Detailed description
OBJECTIVES: I. Assess the short- and long-term local control rates, disease-free survival, and overall survival following treatment with neoadjuvant cisplatin plus fluorouracil followed by surgery with or without radiotherapy vs surgery alone with or without radiotherapy in patients with previously untreated stage II-IV squamous cell carcinoma of the oral cavity. II. Assess the prognostic significance of clinical and pathologic responses to neoadjuvant chemotherapy in these patients. III. Compare the short- and long-term toxic effects of these two regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by center and nodal status (N0 vs N1-2 vs N3). Patients are randomized to one of two treatment arms. Arm I: Patients receive cisplatin IV on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable disease after 2 courses or progressive disease at any time proceed to surgery. Patients undergo resection of the primary tumor site and possible nodal dissection no sooner than 2 weeks after completion of chemotherapy. Patients then undergo radiotherapy over 5-6 weeks no later than 8 weeks after surgery. Arm II: Patients undergo surgery and radiotherapy as in arm I. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then yearly thereafter.
PROJECTED ACCRUAL: A total of 240 patients will be accrued for this study over 9 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 | – |
| fluorouracil | Drug | – |
| conventional surgery | Procedure or surgery | – |
| low-LET cobalt-60 gamma ray therapy | Radiation | – |
| low-LET photon therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
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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.
R. Molinari, MD study chair
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cisplatin, fluorouracil and conventional surgery in people with Head and Neck Cancer, run by European Institute of Oncology at 1 site in Italy.
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: status not confirmed, as of the sponsor's last update on 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Results are not available in the source record.
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?
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 20 Sep 2013.