Neoplasms

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Nasopharyngeal Carcinoma

Nasopharyngeal Neoplasms

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Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

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Otorhinolaryngologic Diseases

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Antineoplastic Agents

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Docetaxel

Fluorouracil

Cisplatin

Induction chemotherapy (Docetaxel + Cisplatin + 5-FU):

* 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 followed by
* 5-Fluorouracil (as a continuous infusion): 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 concurrent chemoradiotherapy with Cisplatin : weekly Cisplatin 40 mg/m2 starting on D1 of the radiation therapy (70 Gy/7 weeks).

Concurrent chemoradiotherapy with Cisplatin : weekly Cisplatin 40 mg/m2 starting on D1 of the radiation therapy (70 Gy/7 weeks).

Induction chemotherapy (Docetaxel, Cisplatin and 5-Fluorouracil) + concurrent radiochemotherapy

Induction chemotherapy + concurrent radiochemotherapy vs. concurrent radiochemotherapy

Jamel Daoud, Pr

Mounir FRIKHA, Pr

Jean BOURHIS, Pr

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.

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

Induction Chemotherapy and Chemoradiotherapy in Nasopharyngeal Cancers

A Randomized, Multicenter, Phase III Trial Comparing Induction CT With Docetaxel, Cisplatin and 5-FU (TPF) Followed by Concurrent CT-RT to Concurrent CT Alone, in Nasopharyngeal Cancers Staged as T2b, T3, T4 and/or With Lymph Node Involvement (>N1)

Groupe Oncologie Radiotherapie Tete et Cou

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Induction Chemotherapy and Chemoradiotherapy in Nasopharyngeal Cancers	NCT00828386	Nasopharyngeal ...	Induction chemo...	18 Years - 70 Years	Groupe Oncologie Radiotherapie Tete et Cou
Induction Chemotherapy and Chemoradiotherapy in Nasopharyngeal Cancers	NCT00828386	Nasopharyngeal ...	Induction chemo...	18 Years - 70 Years	Groupe Oncologie Radiotherapie Tete et Cou

Spots Global Cancer Trial Database for induction chemotherapy + concurrent radiochemotherapy vs. concurrent radiochemotherapy