Oral CancerPhase 3NCT00158678
IMRT Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Stage III-IV HNSCC
A Phase 3 study testing IMRT 75 Gy, Conventional radiotherapy 70 Gy and concomitant cisplatin in people with Oral Cancer and Oropharynx Cancer, run by Groupe Oncologie Radiotherapie Tete et Cou at 2 sites in France.
Trial summary
This is a multicentric randomized phase III trial comparing intensity-modulated radiotherapy (75 Gy) plus cisplatin versus conventional radiotherapy (70 Gy) plus cisplatin in patients with stage III-IV squamous cell carcinoma of oral cavity, oropharynx or hypopharynx. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Cancer, Oropharynx Cancer, Hypopharynx Cancer
- What is being tested?
- IMRT 75 Gy, Conventional radiotherapy 70 Gy and concomitant cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 2 sitesFrance
- Study dates
- 27 Sep 2005to 22 Mar 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- squamous cell carcinoma of oral cavity, oropharynx or hypopharynx
- Stage III - IV (T1-T4, N0-N2)(UICC 2002)
- Not resected
- Indication of radiotherapy to bilateral cervical nodes at dose>= 50 Gy
- Delineation of target volumes done before randomization
- Scintigraphy of parotid gland done before radiotherapy start
- Quality of life questionnaires (EORTC-C30 and EORTC-H\&N35) filled in by the patient
- Informed consent signed
Who cannot join
- N3 (UICC 2002)
- Distant metastasis
- Contra-indication to concomitant cisplatin
- History of cancer within the last 5 years
- History of head and neck radiotherapy
- Administration of drugs for treatment or prophylaxis of xerostomia (pilocarpine, ethyol)
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511
Institut Gustave Roussy
Villejuif, 94800
About this study
Official title: Phase III Trial of Intensity-modulated Radiotherapy Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma
This is a multicentric randomized phase III trial comparing intensity-modulated radiotherapy (75 Gy) plus cisplatin versus conventional radiotherapy (70 Gy) plus cisplatin in patients with stage III-IV squamous cell carcinoma of oral cavity, oropharynx or hypopharynx. The main end points are the rate of locoregional control and the rate of xerostomia at 2 years.
Read the detailed description
This is a multicentric randomized phase III trial comparing intensity-modulated radiotherapy plus concomitant cisplatin versus conventional radiotherapy plus concomitant cisplatin in patients with stage III-IV squamous cell carcinoma of oral cavity, oropharynx or hypopharynx. The main end points are the rate of locoregional control and the rate of xerostomia at 2 years.
The IMRT total dose is 75 Gy (50 Gy to PTV1 and T0 + 25 Gy (10 fractions) to PTV2). The conventional radiotherapy total dose is 70 Gy (50 Gy to PTV1 + 20 Gy (10 fractions) to PTV2). In both arms, the cervical nodes will receive 50 Gy (65 Gy in case of Np) by conventional radiotherapy (IMRT is allowed in the IRMT arm). In the two arms, patients will receive concomitant cisplatin (100 mg/m² D1, D21, D42).
- Conditions
- Oral Cancer, Oropharynx Cancer, Hypopharynx Cancer
- Being tested
- IMRT 75 Gy, Conventional radiotherapy 70 Gy, concomitant cisplatin
- Keywords
- oral cancer, oropharynx cancer, hypopharynx cancer, IMRT
- Medical subject headings
- Mouth Neoplasms, Oropharyngeal Neoplasms, Hypopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMRT 75 GyProcedure or surgery
50 Gy in PTV1 and 25 Gy in 10 fractions in PTV2
Conventional radiotherapy 70 GyProcedure or surgery
50 Gy in PTV1 and 20 Gy in PTV2
concomitant cisplatinDrug
100 mg/m2 D1, D22, D43
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Conventional RT 70Gy + concomitant cisplatin Receives: Procedure: Conventional radiotherapy 70 Gy; Drug: concomitant cisplatin |
| 2 | Experimental | IMRT 75Gy + concomitant cisplatin Receives: Procedure: IMRT 75 Gy; Drug: concomitant cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loco regional control
Measured: 2 years
Secondary outcomes (3)
Survival
Measured: 2 years
Xerostomia at 2 years (evaluated by parotid gland scintigraphy)
Measured: 2 years
Quality of life (EORTC-QLQ-H&N35)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study start27 Sep 2005
- Primary completion22 Mar 2020
- Study completion22 Mar 2020
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 Oral CancerStudies of the same condition, open and under way.
- 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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Oncologie Radiotherapie Tete et Cou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Bourhis, PhD, Principal investigator, Gustave Roussy, Cancer Campus, Grand ParisMichel Lapeyre, MD, Principal investigator, Centre Alexis Vautrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00158678
- Sponsor's protocol ID
- GORTEC 2004-01
- Status last verified
- Apr 2020
- First submitted
- 9 Sep 2005
- Last updated
- 15 Apr 2020
- Results posted
- No
Publications
Tao Y, Auperin A, Blanchard P, Alfonsi M, Sun XS, Rives M, Pointreau Y, Castelli J, Graff P, Wong Hee Kam S, Thariat J, Veresezan O, Heymann S, Renard-Oldrini S, Lafond C, Cornely A, Casiraghi O, Boisselier P, Lapeyre M, Biau J, Bourhis J. Concurrent cisplatin and dose escalation with intensity-modulated radiotherapy (IMRT) versus conventional radiotherapy for locally advanced head and neck squamous cell carcinomas (HNSCC): GORTEC 2004-01 randomized phase III trial. Radiother Oncol. 2020 Sep;150:18-25. doi: 10.1016/j.radonc.2020.05.021. Epub 2020 May 15.
PubMed 32417348
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Trial of Intensity-modulated Radiotherapy Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00158678
- Acronym / sponsor ID
- GORTEC 2004-01
- Conditions
- Oral Cancer, Oropharynx Cancer, Hypopharynx Cancer
- Keywords
- oral cancer, oropharynx cancer, hypopharynx cancer, IMRT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Groupe Oncologie Radiotherapie Tete et CouUniversity, hospital or other
- Study start
- 27 Sep 2005 (actual)
- Primary completion
- 22 Mar 2020 (actual)
- Study completion
- 22 Mar 2020 (actual)
- First posted
- 12 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.
This is a multicentric randomized phase III trial comparing intensity-modulated radiotherapy (75 Gy) plus cisplatin versus conventional radiotherapy (70 Gy) plus cisplatin in patients with stage III-IV squamous cell carcinoma of oral cavity, oropharynx or hypopharynx. The main end points are the rate of locoregional control and the rate of xerostomia at 2 years.
Detailed description
This is a multicentric randomized phase III trial comparing intensity-modulated radiotherapy plus concomitant cisplatin versus conventional radiotherapy plus concomitant cisplatin in patients with stage III-IV squamous cell carcinoma of oral cavity, oropharynx or hypopharynx. The main end points are the rate of locoregional control and the rate of xerostomia at 2 years.
The IMRT total dose is 75 Gy (50 Gy to PTV1 and T0 + 25 Gy (10 fractions) to PTV2). The conventional radiotherapy total dose is 70 Gy (50 Gy to PTV1 + 20 Gy (10 fractions) to PTV2). In both arms, the cervical nodes will receive 50 Gy (65 Gy in case of Np) by conventional radiotherapy (IMRT is allowed in the IRMT arm). In the two arms, patients will receive concomitant cisplatin (100 mg/m² D1, D21, D42).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Conventional radiotherapy 70 Gy, Drug: concomitant cisplatinConventional RT 70Gy + concomitant cisplatin |
| 2 | Experimental | Procedure: IMRT 75 Gy, Drug: concomitant cisplatinIMRT 75Gy + concomitant cisplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- squamous cell carcinoma of oral cavity, oropharynx or hypopharynx
- Stage III - IV (T1-T4, N0-N2)(UICC 2002)
- Not resected
- Indication of radiotherapy to bilateral cervical nodes at dose>= 50 Gy
- Delineation of target volumes done before randomization
Key exclusion criteria (6 listed)
- N3 (UICC 2002)
- Distant metastasis
- Contra-indication to concomitant cisplatin
- History of cancer within the last 5 years
- History of head and neck radiotherapy
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 |
|---|---|---|
| IMRT 75 Gy50 Gy in PTV1 and 25 Gy in 10 fractions in PTV2 | Procedure or surgery | 2 |
| Conventional radiotherapy 70 Gy50 Gy in PTV1 and 20 Gy in PTV2 | Procedure or surgery | 1 |
| concomitant cisplatin100 mg/m2 D1, D22, D43 | Drug | 1, 2 |
Primary outcome
Loco regional control
Time frame: 2 years
3 secondary outcomes
Survival
Time frame: 2 years
Xerostomia at 2 years (evaluated by parotid gland scintigraphy)
Time frame: 2 years
Quality of life (EORTC-QLQ-H&N35)
Time frame: 2 years
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 15 Apr 2020.
- Derived from this study: PubMed 32417348Tao Y, Auperin A, Blanchard P, Alfonsi M, Sun XS, Rives M, Pointreau Y, Castelli J, Graff P, Wong Hee Kam S, Thariat J, Veresezan O, Heymann S, Renard-Oldrini S, Lafond C, Cornely A, Casiraghi O, Boisselier P, Lapeyre M, Biau J, Bourhis J. Concurrent cisplatin and dose escalation with intensity-modulated radiotherapy (IMRT) versus conventional radiotherapy for locally advanced head and neck squamous cell carcinomas (HNSCC): GORTEC 2004-01 randomized phase III trial. Radiother Oncol. 2020 Sep;150:18-25. doi: 10.1016/j.radonc.2020.05.021. Epub 2020 May 15.
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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, PhD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
Michel Lapeyre, MD principal investigator
Centre Alexis Vautrin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IMRT 75 Gy, Conventional radiotherapy 70 Gy and concomitant cisplatin in people with Oral Cancer and Oropharynx Cancer, run by Groupe Oncologie Radiotherapie Tete et Cou at 2 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 8 inclusion and 6 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 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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.
What does the primary outcome measure?
Loco regional control (time frame: 2 years). 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 NCT00158678, 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 15 Apr 2020.