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Sponsored by: |
Groupe Oncologie Radiotherapie Tete et Cou |
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Information provided by: | Groupe Oncologie Radiotherapie Tete et Cou |
ClinicalTrials.gov Identifier: | NCT00828386 |
This is a randomized, multicenter, phase III trial comparing induction chemotherapy with Docetaxel, Cisplatin and 5-Fluorouracil (TPF) followed by concurrent chemoradiotherapy to concurrent chemoradiotherapy alone, in nasopharyngeal cancers staged as T2b, T3, T4 and/or with lymph node involvement (≥ N1. The main end point is the event free survival.
Condition | Intervention | Phase |
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Nasopharyngeal Cancers |
Procedure: Induction chemotherapy + concurrent radiochemotherapy vs. concurrent radiochemotherapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Multicenter, Phase III Trial Comparing Induction Chemotherapy With Docetaxel, Cisplatin and 5-Fluorouracil (TPF) Followed by Concurrent Chemoradiotherapy to Concurrent Chemoradiotherapy Alone, in Nasopharyngeal Cancers Staged as T2b, T3, T4 and/or With Lymph Node Involvement (>N1) |
Estimated Enrollment: | 260 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | September 2014 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Induction chemotherapy + concurrent chemoradiotherapy: Experimental
Induction chemotherapy (Docetaxel + Cisplatin + 5-FU):
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Procedure: Induction chemotherapy + concurrent radiochemotherapy vs. concurrent radiochemotherapy
Induction chemotherapy (Docetaxel, Cisplatin and 5-Fluorouracil) + concurrent radiochemotherapy
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Concurrent radiochemotherapy alone: Active Comparator
Concurrent chemoradiotherapy with Cisplatin : weekly Cisplatin 40 mg/m2 starting on D1 of the radiation therapy (70 Gy/7 weeks).
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Procedure: Induction chemotherapy + concurrent radiochemotherapy vs. concurrent radiochemotherapy
Induction chemotherapy (Docetaxel, Cisplatin and 5-Fluorouracil) + concurrent radiochemotherapy
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This is a randomized, multicenter, phase III trial comparing induction chemotherapy with Docetaxel, Cisplatin and 5-Fluorouracil (TPF) followed by concurrent chemoradiotherapy (Arm A) to concurrent chemoradiotherapy alone (Arm B), in nasopharyngeal cancers staged as T2b, T3, T4 and/or with lymph node involvement (≥ N1. The main end point is the event free survival.
The treatments are :
Arm A:
induction chemotherapy: Docetaxel (75 mg/m² administered on D1 of each course, every 3 weeks via one-hour IV infusion) + Cisplatin(75 mg/m² administered on D1 via one-hour infusion )+ 5-FU (750 mg/m²/d administered as a continuous infusion from D1 to D5. The cycles will be repeated every 3 weeks up to a total of 3 courses.
followed by chemoradiotherapy with Cisplatin (40 mg/m2 starting on D1 of the radiation therapy) during 7 weeks
Arm B: Chemoradiotherapy with Cisplatin alone (40 mg/m2 starting on D1 of the radiation therapy) during 7 weeks
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Hematological function parameters performed within 10 days before inclusion:
Hepatic function parameters performed within 10 days before inclusion:
Exclusion Criteria:
Other serious concurrent medical disease (non-exhaustive list):
A person deprived of liberty or in the care of a guardian.
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Contact: Jamel Daoud, MD | 216 74 246 913 | jamel.daoud@rns.tn |
Contact: Jean Bourhis, MD, PHD | 33 (0)1 42 11 49 31 | jean.boourhis@igr.fr |
France | |
Institut Gustave Roussy | Recruiting |
Villejuif, France, 94805 | |
Contact: Jean BOURHIS, Pr bourhis@igr.fr | |
Principal Investigator: Jean BOURHIS, PR | |
Principal Investigator: Stephane TEMAM | |
Principal Investigator: Joel GUIGAY | |
Hôpital de la Pitié-Salpétrière | Recruiting |
Paris, France, 75013 | |
Contact: Philippe LANG philippe.lang@psl.aphp.fr | |
Morocco | |
University of Casablanca | Not yet recruiting |
Casablanca, Morocco | |
Contact: Abdellatif BENIDER, Pr beniderabdel@yahoo.fr | |
Romania | |
University of Cluj | Not yet recruiting |
Cluj, Romania | |
Contact: Nicolas N GHILEZAN, Pr nghilezan@yahoo.com | |
Sub-Investigator: Elisabetha CIULEANU | |
Tunisia | |
Hôpital Habib Bourguiba | Not yet recruiting |
Sfax, Tunisia | |
Contact: Jamel DAOUD jamel.daoud@rns.tn | |
Sub-Investigator: Mounir FRIKHA | |
Sub-Investigator: DRIDA |
Principal Investigator: | Jamel Daoud, Pr | Hôpital Habib Bourguiba-3029 Sfax-Tunisie |
Principal Investigator: | Mounir FRIKHA, Pr | Hôpital Habib Bourguiba-3029 Sfax-Tunisie |
Principal Investigator: | Jean BOURHIS, Pr | Institut Gustave Roussy, 39 rue Camille Desmoulin, Villejuif, France |
Responsible Party: | GORTEC ( BOURHIS Jean, Pr ) |
Study ID Numbers: | GORTEC-NPC2006 |
Study First Received: | January 22, 2009 |
Last Updated: | January 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00828386 History of Changes |
Health Authority: | France: Ministry of Health |
Nasopharyngeal cancers induction chemotherapy radiochemotherapy |
Docetaxel Nasopharyngeal Carcinoma Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Cisplatin Fluorouracil |
Head and Neck Neoplasms Pharyngeal Neoplasms Stomatognathic Diseases Pharyngeal Diseases Nasopharyngeal Neoplasms |
Neoplasms Otorhinolaryngologic Diseases Neoplasms by Site Otorhinolaryngologic Neoplasms Head and Neck Neoplasms |
Nasopharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases Pharyngeal Diseases Nasopharyngeal Neoplasms |