IMRT Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Stage III-IV HNSCC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-27

Study Completion Date

2020-03-22

Brief Summary

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This is a multicentric randomized phase III trial comparing intensity-modulated radiotherapy (75 Gy) plus cisplatin versus conventional radiotherapy (70 Gy) plus cisplatin in patients with stage III-IV squamous cell carcinoma of oral cavity, oropharynx or hypopharynx. The main end points are the rate of locoregional control and the rate of xerostomia at 2 years.

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Detailed Description

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This is a multicentric randomized phase III trial comparing intensity-modulated radiotherapy plus concomitant cisplatin versus conventional radiotherapy plus concomitant cisplatin in patients with stage III-IV squamous cell carcinoma of oral cavity, oropharynx or hypopharynx. The main end points are the rate of locoregional control and the rate of xerostomia at 2 years.

The IMRT total dose is 75 Gy (50 Gy to PTV1 and T0 + 25 Gy (10 fractions) to PTV2). The conventional radiotherapy total dose is 70 Gy (50 Gy to PTV1 + 20 Gy (10 fractions) to PTV2). In both arms, the cervical nodes will receive 50 Gy (65 Gy in case of Np) by conventional radiotherapy (IMRT is allowed in the IRMT arm). In the two arms, patients will receive concomitant cisplatin (100 mg/m² D1, D21, D42).

Conditions

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Oral Cancer Oropharynx Cancer Hypopharynx Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Conventional RT 70Gy + concomitant cisplatin

Group Type ACTIVE_COMPARATOR

Conventional radiotherapy 70 Gy

Intervention Type PROCEDURE

50 Gy in PTV1 and 20 Gy in PTV2

concomitant cisplatin

Intervention Type DRUG

100 mg/m2 D1, D22, D43

2

IMRT 75Gy + concomitant cisplatin

Group Type EXPERIMENTAL

IMRT 75 Gy

Intervention Type PROCEDURE

50 Gy in PTV1 and 25 Gy in 10 fractions in PTV2

concomitant cisplatin

Intervention Type DRUG

100 mg/m2 D1, D22, D43

Interventions

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IMRT 75 Gy

50 Gy in PTV1 and 25 Gy in 10 fractions in PTV2

Intervention Type PROCEDURE

Conventional radiotherapy 70 Gy

50 Gy in PTV1 and 20 Gy in PTV2

Intervention Type PROCEDURE

concomitant cisplatin

100 mg/m2 D1, D22, D43

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* squamous cell carcinoma of oral cavity, oropharynx or hypopharynx
* Stage III - IV (T1-T4, N0-N2)(UICC 2002)
* Not resected
* Indication of radiotherapy to bilateral cervical nodes at dose\>= 50 Gy
* Delineation of target volumes done before randomization
* Scintigraphy of parotid gland done before radiotherapy start
* Quality of life questionnaires (EORTC-C30 and EORTC-H\&N35) filled in by the patient
* Informed consent signed

Exclusion Criteria

* N3 (UICC 2002)
* Distant metastasis
* Contra-indication to concomitant cisplatin
* History of cancer within the last 5 years
* History of head and neck radiotherapy
* Administration of drugs for treatment or prophylaxis of xerostomia (pilocarpine, ethyol)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No