Condition or disease | Intervention/treatment | Phase |
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Head and Neck Squamous Cell Carcinoma | Drug: Docetaxel Drug: Cisplatin Drug: Fluorouracil Radiation: radiotherapy | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 440 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase III Trial of Laryngeal Preservation Comparing Induction Chemotherapy With Cisplatin, 5-fluorouracil and Docetaxel (TPF) Followed by Radiotherapy and Concomitant Administration of Radiotherapy With Cisplatin |
Actual Study Start Date : | June 25, 2015 |
Estimated Primary Completion Date : | September 24, 2026 |
Estimated Study Completion Date : | September 24, 2028 |
Arm | Intervention/treatment |
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Active Comparator: TPF followed by radiotherapy
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
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)
Other Name: Taxotere
Drug: Cisplatin 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.
Other Name: Cisplatine
Drug: Fluorouracil 5-FU, 750 mg / m² / day administered in continuous infusion from D1 to D5 (or 120 hours)
Other Name: 5 FU
Radiation: radiotherapy Radiotherapy : 70Gy (2Gy/day) for 7 weeks.
Other Name: radiation therapy
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Experimental: Cisplatin and 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
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.
Other Name: Cisplatine
Radiation: radiotherapy Radiotherapy : 70Gy (2Gy/day) for 7 weeks.
Other Name: radiation therapy
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Squamous cell carcinoma of the larynx or hypopharynx, histologically proven, locally advanced:
Exclusion Criteria:
Other concomitant serious medical conditions (partial list):
Contact: Gilles CALAIS, Pr | + 33 247478265 | gilles.calais@univ-tours.fr | |
Contact: Marie-Hélène GIRARD CALAIS | +33 247479121 | rc.corad@chu-tours.fr |
France | |
Hôpital Bretonneau, Service CORad Pôle Henry S Kaplan | Recruiting |
Tours, France, 37044 | |
Contact: Gilles CALAIS, Pr + 33 247478265 gilles.calais@univ-tours.fr | |
Contact: Marie-Hélène GIRARD CALAIS +33 247479121 rc.corad@chu-tours.fr |
Principal Investigator: | Gilles CALAIS | Hôpital Bretonneau, Service CORad Pôle Henry S Kaplan |
Tracking Information | |||||||||
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First Submitted Date ICMJE | March 8, 2016 | ||||||||
First Posted Date ICMJE | November 14, 2017 | ||||||||
Last Update Posted Date | April 10, 2020 | ||||||||
Actual Study Start Date ICMJE | June 25, 2015 | ||||||||
Estimated Primary Completion Date | September 24, 2026 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
free survival [ Time Frame: 24 months after treatment initiation ] Minimum time between randomization and the occurrence of events such as: death, total laryngectomy, tracheotomy.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Trial of Laryngeal Preservation Comparing Induced CT Followed by RT vs CT Concomitant to RT | ||||||||
Official Title ICMJE | Phase III Trial of Laryngeal Preservation Comparing Induction Chemotherapy With Cisplatin, 5-fluorouracil and Docetaxel (TPF) Followed by Radiotherapy and Concomitant Administration of Radiotherapy With Cisplatin | ||||||||
Brief Summary | 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. | ||||||||
Detailed Description |
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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 3 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Head and Neck Squamous Cell Carcinoma | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
440 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | September 24, 2028 | ||||||||
Estimated Primary Completion Date | September 24, 2026 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | France | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03340896 | ||||||||
Other Study ID Numbers ICMJE | GORTEC 2014-03 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Groupe Oncologie Radiotherapie Tete et Cou | ||||||||
Study Sponsor ICMJE | Groupe Oncologie Radiotherapie Tete et Cou | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Groupe Oncologie Radiotherapie Tete et Cou | ||||||||
Verification Date | April 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |