IMRT Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Stage III-IV HNSCC
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ClinicalTrials.gov Identifier: NCT00158678 |
Recruitment Status
:
Active, not recruiting
First Posted
: September 12, 2005
Last Update Posted
: February 16, 2018
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Oral Cancer Oropharynx Cancer Hypopharynx Cancer | Procedure: IMRT 75 Gy Procedure: Conventional radiotherapy 70 Gy Drug: concomitant cisplatin | Phase 3 |
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).
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 310 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase III Trial of Intensity-modulated Radiotherapy Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma |
Study Start Date : | September 2005 |
Estimated Primary Completion Date : | December 2018 |
Estimated Study Completion Date : | December 2018 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Conventional RT 70Gy + concomitant cisplatin
|
Procedure: Conventional radiotherapy 70 Gy
50 Gy in PTV1 and 20 Gy in PTV2
Drug: concomitant cisplatin
100 mg/m2 D1, D22, D43
|
Experimental: 2
IMRT 75Gy + concomitant cisplatin
|
Procedure: IMRT 75 Gy
50 Gy in PTV1 and 25 Gy in 10 fractions in PTV2
Drug: concomitant cisplatin
100 mg/m2 D1, D22, D43
|
- Loco regional control [ Time Frame: 2 years ]
- Survival [ Time Frame: 2 years ]
- Xerostomia at 2 years (evaluated by parotid gland scintigraphy) [ Time Frame: 2 years ]
- Quality of life (EORTC-QLQ-H&N35) [ Time Frame: 2 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

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): NCT00158678
France | |
Centre Alexis Vautrin | |
Vandoeuvre les Nancy, France, 54511 | |
Institut Gustave Roussy | |
Villejuif, France, 94800 |
Principal Investigator: | Jean Bourhis, PhD | Gustave Roussy, Cancer Campus, Grand Paris | |
Principal Investigator: | Michel Lapeyre, MD | Centre Alexis Vautrin |
Additional Information:
Responsible Party: | Groupe Oncologie Radiotherapie Tete et Cou |
ClinicalTrials.gov Identifier: | NCT00158678 History of Changes |
Other Study ID Numbers: |
GORTEC 2004-01 |
First Posted: | September 12, 2005 Key Record Dates |
Last Update Posted: | February 16, 2018 |
Last Verified: | February 2018 |
Keywords provided by Groupe Oncologie Radiotherapie Tete et Cou:
oral cancer oropharynx cancer hypopharynx cancer IMRT |
Additional relevant MeSH terms:
Mouth Neoplasms Oropharyngeal Neoplasms Hypopharyngeal Neoplasms Head and Neck Neoplasms Neoplasms by Site Neoplasms Mouth Diseases |
Stomatognathic Diseases Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Pharyngeal Diseases Otorhinolaryngologic Diseases Cisplatin Antineoplastic Agents |