A Phase 3 interventional study of Docetaxel and Cisplatin in Head and Neck Squamous Cell Carcinoma, sponsored by Groupe Oncologie Radiotherapie Tete et Cou. Active, not recruiting at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Groupe Oncologie Radiotherapie Tete et Cou · Phase 3, Interventional, and Treatment
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Among 115 studies testing cisplatin in Squamous Cell Carcinoma of Head and Neck — 19 open to participants now, 31 under way, 5 of them phase 3. Cisplatin · Squamous Cell Carcinoma of Head and Neck.
Among the 115 studies testing cisplatin in Squamous Cell Carcinoma of Head and Neck, this one is the 12th largest by enrollment of the 107 interventional ones that give a count, is one of 5 that started in 2015, is one of 14 in phase 3, reaches primary completion later than 21 of the 30 other live ones, and was the 77th registered.
2,019 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
Browse Squamous Cell Carcinoma of Head and Neck studies →19 of the 115 studies testing cisplatin in Squamous Cell Carcinoma of Head and Neck are open now, in 4 countries. Recruiting first, the newest first:
University of Miami · Sites in United States
Ages 18+
Sara Medek · Sites in United States
Ages 18+
Massachusetts General Hospital · Sites in United States
Ages 18+
Rui You · Sites in China
Ages 18–75
University of Michigan Rogel Cancer Center · Sites in United States
Ages 18+
By country, each count listing its studies:
Cisplatin: first FDA approval 1978 (PLATINOL-AQ). What it is approved for, and how studies give it, is on its page →
Of the 433 Squamous Cell Carcinoma of Head and Neck studies recruiting now, 309 (71%) set no upper age limit and 87 (20%) stop at 75 or younger; 5 take children under 18; 13 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
115 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 26 · Phase 2 83 · Phase 3 18
First in 1988; this study’s year is marked. 5 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 256 is above the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Median enrollment 47 across the 107 interventional studies. Of the 74 that completed or were terminated, 28 (38%) have results posted.
This tab as a report to print or save as PDF → With an account.
7 of 115 have an industry lead sponsor. The 10 most frequent:
Groupe Oncologie Radiotherapie Tete et Cou is the lead sponsor of 33 studies on the registry; 5 are open to participants now.
22 studies in Squamous Cell Carcinoma of Head and Neck by Groupe Oncologie Radiotherapie Tete et Cou: 3 open now, 8 under way, 5 of them phase 3. Of 14 finished, 1 (7%) have results posted.
Among the 22 studies in Squamous Cell Carcinoma of Head and Neck by Groupe Oncologie Radiotherapie Tete et Cou, this one is the 9th largest by enrollment of the 21 interventional ones that give a count, is one of 3 that started in 2015, is one of 10 in phase 3, and was the 12th registered.
Groupe Oncologie Radiotherapie Tete et Cou’s Squamous Cell Carcinoma of Head and Neck studies by the year they started, since 2000.
3 of the studies testing cisplatin in Squamous Cell Carcinoma of Head and Neck that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04502407Cedars-Sinai Medical CenterTrial of De-Intensified Post-operative Chemoradiation Following Robotic Surgery for HPV-positive Oropharyngeal Cancer | 2026-12-15 |
| NCT06323460Ohio State University Comprehensive Cancer CenterAdaptive De-intensified Radiotherapy Using Circulating Tumor DNA in HPV- Associated Oropharyngeal Cancer | 2026-12-31 |
| NCT07371234Rui YouLow-Dose Radiotherapy and Anti-PD-1 Immunotherapy as Neoadjuvant Treatment for Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma | 2027-01-15 |
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Among the 115 studies testing cisplatin in Squamous Cell Carcinoma of Head and Neck, from their registry updates:
Among Groupe Oncologie Radiotherapie Tete et Cou’s 22 in Squamous Cell Carcinoma of Head and Neck:
This tab as a report to print or save as PDF → With an account.
This study compare the survival without laryngeal dysfunction 2 years after the end of treatment, obtained by chemotherapy followed by radiotherapy or chemotherapy with cisplatin administrated during radiotherapy.
In patients with tumors classified as T3 or T4 larynx and hypopharynx, the usually recommended treatment was total laryngectomy.This intervention allows to obtain locoregional disease control in 75% of cases, without laryngectomy
TPF arm followed by radiotherapy was validated in a Phase III (GORTEC 2000-01), it will be the standard treatment.
The RTOG study concluded that chemotherapy administrated during radiotherapy became a standard of laryngeal preservation.
Taking together all these considerations, it is necessary to perform a direct comparison in a randomized trial to further test this hypothesis. Chemotherapy followed by radiotherapy will be the standard arm. It hopes to increase the survival rate from 52% to 65% in the experimental arm.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Squamous cell carcinoma of the larynx or hypopharynx, proven, locally advanced:
Exclusion Criteria:
Other concomitant serious medical conditions (partial list):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Induction chemotherapy by Docetaxel 75 mg/m² day 1,cisplatin 75 mg/m² day 1 and 5 fluorouracil 750mg/m²(day 1 to day 5) 3 cycles day1, day 22, day 43 followed (for responders or stable disease patients) by radiotherapy Radiotherapy ;70 gray fractionization: 2Gy/day, 5days/week, for 7 weeks.
Drug: Docetaxel · Drug: Cisplatin · Drug: Fluorouracil · Radiation: radiotherapy
Drug and radiation • Cisplatin: 100 mg / m² administered IV at J1, J22 and J43 of radiotherapy . Radiotherapy 70 gray fractionization: 2Gy/day, 5days/week, for 7 weeks.
Drug: Cisplatin · Radiation: radiotherapy
Docetaxel 75 mg / m² administered on day 1 of each cycle every 3 weeks as an intravenous (IV) infusion of one hour followed by cisplatin 75 mg / m² administered on day 1 hour infusion followed by 5-FU, 750 mg / m² / day administered in continuous infusion from D1 to D5 (or 120 hours)
Also known as: Taxotere
Cisplatin: 75 mg/m² for experimental arm and 100mg/m² for comparator arm administered on day 1 of each cycle every 3 weeks as an intravenous (IV) infusion.
Also known as: Cisplatine
5-FU, 750 mg / m² / day administered in continuous infusion from D1 to D5 (or 120 hours)
Also known as: 5 FU
Radiotherapy : 70Gy (2Gy/day) for 7 weeks.
Also known as: radiation therapy
free survival
Minimum time between randomization and the occurrence of events such as: death, total laryngectomy, tracheotomy.
Time frame: 24 months after treatment initiation
Overall survival
"From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months").
Time frame: 60 months
Progression free survival
"From date of randomization until the date of first documented progression assessed up to 60 months").
Time frame: 60 months
Larynx Preservation
From date of randomization up to 24 months evaluated by dynamic deglutition videoscopy
Time frame: 24 months after treatment initiation
Feasibility of salvage surgery
Assessing the number of recurrences that could be successfully treated with salvage surgery and description of postoperative
Time frame: 60 months after randomization
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2015 (actual). Primary completion is estimated for Oct 2028, 160 months after the start.
Of 51 non-industry phase 3 interventional studies under Squamous Cell Carcinoma of Head and Neck, half reached primary completion within 95 months of starting (the median), counting those still running; a quarter within 67 and three quarters within 121. This study's planned 160 months is above that.
Counting every sponsor, half of 78 studies reached it within 76 months; a quarter within 38 and three quarters within 117.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cisplatin
Squamous Cell Carcinoma of Head and Neck →
Groupe Oncologie Radiotherapie Tete et Cou