Status:
COMPLETED
Adaptative Radiotherapy to Decrease Xerostomia in Oropharynx Carcinoma
Lead Sponsor:
Center Eugene Marquis
Conditions:
Oropharynx Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The Phase III study will include 174 patients with locally advanced oropharynx carcinoma, receiving all arc-IMRT (Intensity-Modulated Radiation Therapy) (70 Gy) with concomitant systemic therapy. Two ...
Eligibility Criteria
Inclusion
- Locally advanced non-metastatic carcinoma of the oropharynx limited to T3 and T4 (whatever the N) and N2-N3 (whatever the T)(AJCC stage III-IV)
- Age ≥ 18 years and ≤ 75 years
- Performance status (WHO ≤ 2)
- Renal, hepatic and cardiovascular functions allowing systemic treatment administration
- Adapted stomatologic care
- Signed informed consent form
- Membership or beneficiary of a national insurance scheme
Exclusion
- Both parotids totally included in the target volume
- Stages T1 or T2 with positive node disease N1
- Neoadjuvant chemotherapy
- Exereses of primitive tumor and/or nodes
- History of other cancer within 5 years (except for basocellular epithelioma and cervical)
- Previous neck radiotherapy
- Platinum salts, 5FluoroUracile (5FU) agents or cetuximab chemotherapy considerations
- Unstable diseases (cardiovascular, renal, pulmonary, systemic lupus or sclerodermia)incompatible with study participation
- Patient participating in other therapeutic trial with experimental drug, 30 days before the inclusion.
- Patient already recruited in another biomedical research ( non interventional study is authorized)
- Pregnant or breast feeding patients
- Patient deprived of liberty, under tutorship, guardianship or placed under judicial protection
- Patient is deemed incapable of giving informed consent
- Patients who, for family, social, geographic or psychological reasons, cannot be adequately followed up and/or are incapable of undergoing regular controls.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2020
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT01874587
Start Date
July 1 2013
End Date
December 8 2020
Last Update
July 27 2021
Active Locations (11)
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1
Clinique Claude Bernard
Albi, France
2
Clinique Pasteur - Saint Esprit
Brest, France, 29200
3
CRLCC Baclesse
Caen, France, 14076
4
CRLCC Oscar Lambret
Lille, France, 59020