Oropharynx CancerPhase 2/3NCT00162708
Very Intense Radiotherapy-chemotherapy Regimen in Advanced HNSCC
A Phase 2/3 study testing Radiotherapy 62-64 Gy in 5 W (31-32 f. of 2 Gy BID), Radiotherapy 62-64 Gy in 22-23 D (31-32 f of 2 Gy BID) and CDDP, 5 Fu in people with Oropharynx Cancer and Oral Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 3 sites in France.
Trial summary
Altered fractionated radiotherapy and concomitant radio-chemotherapy have been shown to be two possibilities for improving efficacy of radiotherapy in locally advanced head and neck carcinomas. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Oropharynx Cancer, Oral Cancer, Hypopharynx Cancer
- What is being tested?
- Radiotherapy 62-64 Gy in 5 W (31-32 f. of 2 Gy BID), Radiotherapy 62-64 Gy in 22-23 D (31-32 f of 2 Gy BID) and CDDP, 5 Fu
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 3 sitesFrance
- Study dates
- Jul 1996to not given
- Phase
- Phase 2/3
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- palpable N2b-c or N3 (UICC 1997) squamous cell carcinoma of the head and neck (oropharynx, oral cavity, hypopharynx or larynx)
- primary tumor and / or nodal extension strictly inoperable due to the extension of the disease
- performance status of 0 to 2 (WHO scoring system)
- renal/liver/cardiac functions and blood counts compatible with the use of CDDP and 5-FU
- signed inform consent
Who cannot join
- distant metastasis
- previous history of cancer
- previous radiotherapy or chemotherapy
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Jean Perrin
Clermont-Ferrand
Centre Alexis Vautrin
Nancy
Institut Gustave Roussy
Villejuif, 94800
About this study
Official title: A Randomized Trial Evaluating a Very Intense Radiotherapy-chemotherapy Regimen Versus a Very Accelerated Radiotherapy in Advanced Head and Neck Squamous Cell Carcinoma
Altered fractionated radiotherapy and concomitant radio-chemotherapy have been shown to be two possibilities for improving efficacy of radiotherapy in locally advanced head and neck carcinomas. In this multicentric study, we tested the hypothesis that accelerated radiotherapy could be delivered concomitantly with conventional high doses of CDDP-5FU, aiming to improve both local control and on distant metastases as compared to very accelerated radiotherapy.
Read the detailed description
Patients with a palpable N2b-c or N3 HNSCC strictly unresectable were randomized to receive either accelerated RT-CT delivering to the primary tumor 62-64 Gy / 5 weeks in 31-32 fractions of 2 Gy BID or very accelerated RT delivering 62-64 Gy in 31-32 fractions of 2 Gy BID and 22-23 days. In the accelerated RT-CT arm, 3 cycles of CDDP 100 mg/m2 were delivered at day 1, 16, 32 and 2 cycles of 5 Fu 1000 mg/m2 day 1 to 5 and 31 to 35. One month after completion of the concomitant RT-CT, 2 additional cycles of CDDP-5FU were given in patients responding (> 50%) to the initial course of RT-CT. The end points were event free survival and survival.
- Conditions
- Oropharynx Cancer, Oral Cancer, Hypopharynx Cancer, Larynx Cancer
- Being tested
- Radiotherapy 62-64 Gy in 5 W (31-32 f. of 2 Gy BID), Radiotherapy 62-64 Gy in 22-23 D (31-32 f of 2 Gy BID), CDDP, 5 Fu
- Keywords
- Head and neck squamous cell carcinoma, Radiotherapy, Chemotherapy
- Medical subject headings
- Oropharyngeal Neoplasms, Mouth Neoplasms, Hypopharyngeal Neoplasms, Laryngeal 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.
Radiotherapy 62-64 Gy in 5 W (31-32 f. of 2 Gy BID)Procedure or surgery
Radiotherapy 62-64 Gy in 22-23 D (31-32 f of 2 Gy BID)Procedure or surgery
CDDP, 5 FuDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Event free survival (event = progressive disease or relapse or or death from any cause)
Secondary outcomes (2)
Survival
Toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startJul 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oropharynx CancerStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Bourhis, Principal investigator, Gustave Roussy, Cancer Campus, Grand ParisMichel Lapeyre, Principal investigator, Centre Alexis VautrinJacques Tortochaux, Principal investigator, Centre Jean Perrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00162708
- Sponsor's protocol ID
- VADN3
- Other IDs
- GORTEC
- Status last verified
- Aug 2026
- First submitted
- 9 Sep 2005
- Last updated
- 19 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bourhis J, Lapeyre M, Tortochaux J, Lusinchi A, Etessami A, Ducourtieux M, Geoffrois L, Domenge C, Verrelle P, Wibault P, Janot F, Temam S, Blanchard P, Tao YG, Auperin A. Accelerated radiotherapy and concomitant high dose chemotherapy in non resectable stage IV locally advanced HNSCC: results of a GORTEC randomized trial. Radiother Oncol. 2011 Jul;100(1):56-61. doi: 10.1016/j.radonc.2011.07.006. Epub 2011 Aug 8.
PubMed 21831465
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Evaluating a Very Intense Radiotherapy-chemotherapy Regimen Versus a Very Accelerated Radiotherapy in Advanced Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00162708
- Acronym / sponsor ID
- VADN3
- Conditions
- Oropharynx Cancer, Oral Cancer, Hypopharynx Cancer, Larynx Cancer
- Keywords
- Head and neck squamous cell carcinoma, Radiotherapy, Chemotherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- Jul 1996
- First posted
- 13 Sep 2005 (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.
Altered fractionated radiotherapy and concomitant radio-chemotherapy have been shown to be two possibilities for improving efficacy of radiotherapy in locally advanced head and neck carcinomas. In this multicentric study, we tested the hypothesis that accelerated radiotherapy could be delivered concomitantly with conventional high doses of CDDP-5FU, aiming to improve both local control and on distant metastases as compared to very accelerated radiotherapy.
Detailed description
Patients with a palpable N2b-c or N3 HNSCC strictly unresectable were randomized to receive either accelerated RT-CT delivering to the primary tumor 62-64 Gy / 5 weeks in 31-32 fractions of 2 Gy BID or very accelerated RT delivering 62-64 Gy in 31-32 fractions of 2 Gy BID and 22-23 days. In the accelerated RT-CT arm, 3 cycles of CDDP 100 mg/m2 were delivered at day 1, 16, 32 and 2 cycles of 5 Fu 1000 mg/m2 day 1 to 5 and 31 to 35. One month after completion of the concomitant RT-CT, 2 additional cycles of CDDP-5FU were given in patients responding (> 50%) to the initial course of RT-CT. The end points were event free survival and survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- palpable N2b-c or N3 (UICC 1997) squamous cell carcinoma of the head and neck (oropharynx, oral cavity, hypopharynx or larynx)
- primary tumor and / or nodal extension strictly inoperable due to the extension of the disease
- performance status of 0 to 2 (WHO scoring system)
- renal/liver/cardiac functions and blood counts compatible with the use of CDDP and 5-FU
- signed inform consent
Key exclusion criteria (3 listed)
- distant metastasis
- previous history of cancer
- previous radiotherapy or chemotherapy
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 |
|---|---|---|
| Radiotherapy 62-64 Gy in 5 W (31-32 f. of 2 Gy BID) | Procedure or surgery | – |
| Radiotherapy 62-64 Gy in 22-23 D (31-32 f of 2 Gy BID) | Procedure or surgery | – |
| CDDP, 5 Fu | Drug | – |
Primary outcome
Event free survival (event = progressive disease or relapse or or death from any cause)
2 secondary outcomes
Survival
Toxicity
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 19 Aug 2026.
- Results publication: PubMed 21831465Bourhis J, Lapeyre M, Tortochaux J, Lusinchi A, Etessami A, Ducourtieux M, Geoffrois L, Domenge C, Verrelle P, Wibault P, Janot F, Temam S, Blanchard P, Tao YG, Auperin A. Accelerated radiotherapy and concomitant high dose chemotherapy in non resectable stage IV locally advanced HNSCC: results of a GORTEC randomized trial. Radiother Oncol. 2011 Jul;100(1):56-61. doi: 10.1016/j.radonc.2011.07.006. Epub 2011 Aug 8.
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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.
Jean Bourhis principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
Michel Lapeyre principal investigator
Centre Alexis Vautrin
Jacques Tortochaux principal investigator
Centre Jean Perrin
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Radiotherapy 62-64 Gy in 5 W (31-32 f. of 2 Gy BID), Radiotherapy 62-64 Gy in 22-23 D (31-32 f of 2 Gy BID) and CDDP, 5 Fu in people with Oropharynx Cancer and Oral Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. 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 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
What does the primary outcome measure?
Event free survival (event = progressive disease or relapse or or death from any cause). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00162708, which also lists 1 linked publication.
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 19 Aug 2026.