Induction Chemotherapy and Chemoradiotherapy in Nasopharyngeal Cancers (NPC2006)
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ClinicalTrials.gov Identifier: NCT00828386 |
Recruitment Status :
Terminated
(Low accrual)
First Posted : January 23, 2009
Last Update Posted : January 18, 2019
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Condition or disease | Intervention/treatment | Phase |
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Nasopharyngeal Cancers | Procedure: Induction chemotherapy + concurrent radiochemotherapy vs. concurrent radiochemotherapy | Phase 3 |
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
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 83 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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) |
Study Start Date : | January 2009 |
Actual Primary Completion Date : | April 19, 2017 |
Actual Study Completion Date : | April 19, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Induction chemotherapy + concurrent chemoradiotherapy
Induction chemotherapy (Docetaxel + Cisplatin + 5-FU):
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). |
Procedure: Induction chemotherapy + concurrent radiochemotherapy vs. concurrent radiochemotherapy
Induction chemotherapy (Docetaxel, Cisplatin and 5-Fluorouracil) + concurrent radiochemotherapy |
Active Comparator: Concurrent radiochemotherapy alone
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 |
- Event free-survival [ Time Frame: 3 years ]
- Survival [ Time Frame: 3 years ]
- late and acute toxicity according to NCI-CTC and EORTC/RTOG criteria [ Time Frame: early and late ]
- Cumulative incidence of loco-regional progression [ Time Frame: 3 years ]
- Cumulative rate of metastasis [ Time Frame: 3 years ]
- Global response to chemo-radiotherapy [ Time Frame: 3 years ]
- Global response to induction chemotherapy [ Time Frame: after the induction chemotherapy of the last patient included ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- WHO II-III carcinoma of the nasopharynx, histologically proven by a nasal cavity biopsy, locally advanced T2b, T3, T4 and/or N1, N2 or N3 (UICC/AJCC2002).
- Absence of distant metastases, confirmed by a chest CT scan, abdominal ultrasound (or CT scan) in case of abnormal hepatic function, and bone scintigraphy required.
- Total absence of previous chemotherapy or radiotherapy, for whatever reason.
- Total absence of surgical procedures for nasopharyngeal carcinoma.
- Total absence of concurrent cancer treatment.
- Total absence of chronic treatment (>= 3 months) with corticosteroids with a daily dosage >= 20 mg/day of methylprednisolone or equivalent.
- Age between 18 and 70 years.
- Performance status 0 or 1 according to the WHO criteria.
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Hematological function parameters performed within 10 days before inclusion:
- Neutrophils >= 1.5 * 109/l
- Platelets: >= 100 * 109/l
- Hemoglobin: >= 10 g/dl
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Hepatic function parameters performed within 10 days before inclusion:
- Total bilirubin is normal
- AST (SGOT) and ALT (SGPT) <= 2.5 * upper limit of normal (ULN) of each center.
- Alkaline phosphatase <= 2.5 * ULN.
- Renal function parameters performed within 10 days before inclusion: Creatinine clearance must be <= 55 ml/min.
- Patient who has given his/her written consent before any specific procedure of the protocol.
- Patient having a Social Security (social policy-holders)
Exclusion Criteria:
- WHO I carcinoma of the nasopharynx, histologically proven by a nasal cavity biopsy.
- Other previous or concomitant cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma.
- Histological diagnosis on a lymph node biopsy.
- Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures.
- Symptomatic peripheral neuropathy with grade >= 2 according to the NCI-CTC criteria.
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Other serious concurrent medical disease (non-exhaustive list):
- Unstable heart disease despite treatment.
- Myocardial infarction within 6 months before inclusion in the trial.
- A history of neurological or psychiatric events such as dementia, convulsions.
- Severe uncontrolled infection.
- Active gastroduodenal ulcer.
- Obstructive Pulmonary Disease requiring hospitalization within the year prior to inclusion.
- Clinical impairment of auditory function.
- The presence, at time of screening, of psychological, familial, social or geographical factors that may have an effect on the compliance of the patient with the study protocol and monitoring comprises an exclusion criterion. These factors must be discussed with the patient before his or her inclusion in the trial.
- Hypersensitivity to the excipients.
- A patient already enrolled in another therapeutic trial on an investigational compound.
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A person deprived of liberty or in the care of a guardian.
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00828386
France | |
Hôpital de la Pitié-Salpétrière | |
Paris, France, 75013 | |
Institut Gustave Roussy | |
Villejuif, France, 94805 | |
Morocco | |
University of Casablanca | |
Casablanca, Morocco | |
Romania | |
University of Cluj | |
Cluj, Romania | |
Tunisia | |
Hôpital Habib Bourguiba | |
Sfax, Tunisia |
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: | Groupe Oncologie Radiotherapie Tete et Cou |
ClinicalTrials.gov Identifier: | NCT00828386 |
Other Study ID Numbers: |
GORTEC NPC2006 |
First Posted: | January 23, 2009 Key Record Dates |
Last Update Posted: | January 18, 2019 |
Last Verified: | January 2019 |
Nasopharyngeal cancers induction chemotherapy radiochemotherapy |
Nasopharyngeal Neoplasms Nasopharyngeal Carcinoma Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site Neoplasms |
Nasopharyngeal Diseases Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |