Oral CancerPhase 3NCT00158652
Accelerated Radiotherapy and Concomitant Chemo-radiotherapy in HNSCC
A Phase 3 study testing Conventional radiotherapy 70 Gy in 7 weeks, middle accelerated radiotherapy 70 Gy in 6 weeks and very accelerated radiotherapy 64.8 Gy in 3.5 weeks 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 conventional radiotherapy with concomitant chemotherapy versus accelerated radiotherapy with concomitant chemotherapy versus very accelerated radiotherapy in patients with stage III-IV head and neck squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Oral Cancer, Oropharynx Cancer, Hypopharynx Cancer
- What is being tested?
- Conventional radiotherapy 70 Gy in 7 weeks, middle accelerated radiotherapy 70 Gy in 6 weeks and very accelerated radiotherapy 64.8 Gy in 3.5 weeks
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 840 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2000to Mar 2011
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Squamous cell carcinoma of oral cavity, oropharynx, hypopharynx or larynx
- Stage III-IV (UICC 1997): T2, T3 or T4 with N0-N3 or T0 with N2-N3
- Not resectable
- Karnofsky PS >= 70
- Renal/liver/cardiac functions and blood counts compatible with the use of paraplatin and 5-FU
- Informed consent signed
Who cannot join
- Distant metastasis
- Contra-indication to concomitant chemotherapy
- History of cancer
- History of head and neck radiotherapy
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Tours
Tours, 37 044
Institut Gustave Roussy
Villejuif, 94800
About this study
Official title: Phase III Trial Comparing Conventional RT With Concomitant CT Versus Accelerated RT With Concomitant CT Versus Very Accelerated RT Alone in Patients With Head and Neck Squamous Cell Carcinoma
This is a multicentric randomized phase III trial comparing conventional radiotherapy with concomitant chemotherapy versus accelerated radiotherapy with concomitant chemotherapy versus very accelerated radiotherapy in patients with stage III-IV head and neck squamous cell carcinoma. The main end point is the event free survival.
Read the detailed description
This is a multicentric randomized phase III trial comparing conventional radiotherapy with concomitant chemotherapy (arm A) versus middle accelerated radiotherapy with concomitant chemotherapy (arm B) versus very accelerated radiotherapy alone (arm C) in patients with stage III-IV head and neck squamous cell carcinoma (HNSCC). The main end point is the event free survival.
The treatments are
Bras A : Conventional radiotherapy given once daily, delivering 70 Gy in 7 weeks (5 fractions of 2 Gy per week) and chemotherapy: 5FU : 600 mg/m²/d, Paraplatin : 70 mg/m²/d, D1-4 and D22-25 and D43-46
Bras B: middle accelerated radiotherapy delivering 70 Gy in 6 weeks and chemotherapy: 5FU : 600 mg/m²/d, Paraplatin : 70 mg/m²/d, D1-5 and D29-33
- first part : radiotherapy given once daily delivering 40 Gy in 4 weeks and 20 fractions of 2 Gy
- second part : radiotherapy given twice daily with "concomitant boost" delivering 30 Gy in 20 fractions in 2 weeks (1,5 Gy x 2 / day)
Bras C: very accelerated radiotherapy given twice daily delivering 64.8 Gy in 3.5 weeks in 36 fractions of 1.8 Gy
- Conditions
- Oral Cancer, Oropharynx Cancer, Hypopharynx Cancer, Larynx Cancer
- Being tested
- Conventional radiotherapy 70 Gy in 7 weeks, middle accelerated radiotherapy 70 Gy in 6 weeks, very accelerated radiotherapy 64.8 Gy in 3.5 weeks, 5FU, Paraplatin
- Keywords
- Head and neck squamous cell carcinoma, Radiotherapy, Chemotherapy
- Medical subject headings
- Mouth Neoplasms, Oropharyngeal 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.
Conventional radiotherapy 70 Gy in 7 weeksProcedure or surgery
2 gy per fraction, 1 fraction per day, 5 fractions per week
middle accelerated radiotherapy 70 Gy in 6 weeksProcedure or surgery
5 x 2gy/week until 40 Gy in 20 fractions and 4 weeks, then 2 fractions of 1.5Gy per day for 30 additional Gy in 2 weeks
very accelerated radiotherapy 64.8 Gy in 3.5 weeksProcedure or surgery
2 fractions of 1.8 Gy per day for 64.8 Gy in 3.5 weeks
5FU, ParaplatinDrug
5FU 600mg/m²/D, Paraplatin 70mg/m²/D In arm 1: D1-4, 3 cycles during Rth (D1, D22, D43) In arm 2: D1-5, 2 cycles during Rth (D1, D29)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Procedure: Conventional radiotherapy 70 Gy in 7 weeks; Drug: 5FU, Paraplatin |
| 2 | Experimental | Not described Receives: Procedure: middle accelerated radiotherapy 70 Gy in 6 weeks; Drug: 5FU, Paraplatin |
| 3 | Experimental | Not described Receives: Procedure: very accelerated radiotherapy 64.8 Gy in 3.5 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event free survival (event=progression, relapse, death from any cause)
Measured: 3 years
Secondary outcomes (3)
Survival
Measured: 3 years
Loco regional control
Measured: 3 years
Toxicity
Measured: early and late
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 startMar 2000
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 840 participants (actual)
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 ParisGilles Calais, Principal investigator, CHU Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00158652
- Sponsor's protocol ID
- GORTEC 99-02
- Status last verified
- Nov 2011
- First submitted
- 9 Sep 2005
- Last updated
- 8 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Trial Comparing Conventional RT With Concomitant CT Versus Accelerated RT With Concomitant CT Versus Very Accelerated RT Alone in Patients With Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00158652
- Acronym / sponsor ID
- GORTEC 99-02
- Conditions
- Oral Cancer, Oropharynx Cancer, Hypopharynx Cancer, Larynx Cancer
- Keywords
- Head and neck squamous cell carcinoma, Radiotherapy, Chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 840 participants (actual)
- Lead sponsor
- Groupe Oncologie Radiotherapie Tete et CouUniversity, hospital or other
- Study start
- Mar 2000
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (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 conventional radiotherapy with concomitant chemotherapy versus accelerated radiotherapy with concomitant chemotherapy versus very accelerated radiotherapy in patients with stage III-IV head and neck squamous cell carcinoma. The main end point is the event free survival.
Detailed description
This is a multicentric randomized phase III trial comparing conventional radiotherapy with concomitant chemotherapy (arm A) versus middle accelerated radiotherapy with concomitant chemotherapy (arm B) versus very accelerated radiotherapy alone (arm C) in patients with stage III-IV head and neck squamous cell carcinoma (HNSCC). The main end point is the event free survival.
The treatments are
Bras A : Conventional radiotherapy given once daily, delivering 70 Gy in 7 weeks (5 fractions of 2 Gy per week) and chemotherapy: 5FU : 600 mg/m²/d, Paraplatin : 70 mg/m²/d, D1-4 and D22-25 and D43-46
Bras B: middle accelerated radiotherapy delivering 70 Gy in 6 weeks and chemotherapy: 5FU : 600 mg/m²/d, Paraplatin : 70 mg/m²/d, D1-5 and D29-33
- first part : radiotherapy given once daily delivering 40 Gy in 4 weeks and 20 fractions of 2 Gy
- second part : radiotherapy given twice daily with "concomitant boost" delivering 30 Gy in 20 fractions in 2 weeks (1,5 Gy x 2 / day)
Bras C: very accelerated radiotherapy given twice daily delivering 64.8 Gy in 3.5 weeks in 36 fractions of 1.8 Gy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Conventional radiotherapy 70 Gy in 7 weeks, Drug: 5FU, Paraplatin |
| 2 | Experimental | Procedure: middle accelerated radiotherapy 70 Gy in 6 weeks, Drug: 5FU, Paraplatin |
| 3 | Experimental | Procedure: very accelerated radiotherapy 64.8 Gy in 3.5 weeks |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Squamous cell carcinoma of oral cavity, oropharynx, hypopharynx or larynx
- Stage III-IV (UICC 1997): T2, T3 or T4 with N0-N3 or T0 with N2-N3
- Not resectable
- Karnofsky PS >= 70
- Renal/liver/cardiac functions and blood counts compatible with the use of paraplatin and 5-FU
Key exclusion criteria (4 listed)
- Distant metastasis
- Contra-indication to concomitant chemotherapy
- History of cancer
- 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 |
|---|---|---|
| Conventional radiotherapy 70 Gy in 7 weeks2 gy per fraction, 1 fraction per day, 5 fractions per week | Procedure or surgery | 1 |
| middle accelerated radiotherapy 70 Gy in 6 weeks5 x 2gy/week until 40 Gy in 20 fractions and 4 weeks, then 2 fractions of 1.5Gy per day for 30 additional Gy in 2 weeks | Procedure or surgery | 2 |
| very accelerated radiotherapy 64.8 Gy in 3.5 weeks2 fractions of 1.8 Gy per day for 64.8 Gy in 3.5 weeks | Procedure or surgery | 3 |
| 5FU, Paraplatin5FU 600mg/m²/D, Paraplatin 70mg/m²/D In arm 1: D1-4, 3 cycles during Rth (D1, D22, D43) In arm 2: D1-5, 2 cycles during Rth (D1, D29) | Drug | 1, 2 |
Primary outcome
Event free survival (event=progression, relapse, death from any cause)
Time frame: 3 years
3 secondary outcomes
Survival
Time frame: 3 years
Loco regional control
Time frame: 3 years
Toxicity
Time frame: early and late
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 8 Nov 2011.
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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
Gilles Calais principal investigator
CHU Tours
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 Conventional radiotherapy 70 Gy in 7 weeks, middle accelerated radiotherapy 70 Gy in 6 weeks and very accelerated radiotherapy 64.8 Gy in 3.5 weeks 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 6 inclusion and 4 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 8 Nov 2011. 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?
Event free survival (event=progression, relapse, death from any cause) (time frame: 3 years). It is what the study was designed to measure, not a finding.
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 8 Nov 2011.