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Phase III Trial Testing the Benefit of Intensity-modulated Radiotherapy With Weekly Replanifications Versus Intensity Modulated Radiotherapy With Only One Planification in Locally Advanced Oropharynx Carcinoma for Decreasing Xerostomia


Phase 3
18 Years
75 Years
Not Enrolling
Both
Oropharynx Cancer

Thank you

Trial Information

Phase III Trial Testing the Benefit of Intensity-modulated Radiotherapy With Weekly Replanifications Versus Intensity Modulated Radiotherapy With Only One Planification in Locally Advanced Oropharynx Carcinoma for Decreasing Xerostomia


Inclusion Criteria:



1. 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)

2. Age ≥ 18 years and ≤ 75 years

3. Performance status (WHO ≤ 2)

4. Renal, hepatic and cardiovascular functions allowing systemic treatment
administration

5. Adapted stomatologic care

6. Signed informed consent form

7. Membership or beneficiary of a national insurance scheme

Exclusion Criteria:

1. Both parotids totally included in the target volume

2. Stages T1 or T2 with positive node disease N1

3. Neoadjuvant chemotherapy

4. Exereses of primitive tumor and/or nodes

5. History of other cancer within 5 years (except for basocellular epithelioma and
cervical)

6. Previous neck radiotherapy

7. Platinum salts, 5FluoroUracile (5FU) agents or cetuximab chemotherapy considerations

8. Unstable diseases (cardiovascular, renal, pulmonary, systemic lupus or
sclerodermia)incompatible with study participation

9. Patient participating in other therapeutic trial with experimental drug, 30 days
before the inclusion.

10. Patient already recruited in another biomedical research ( non interventional study
is authorized)

11. Pregnant or breast feeding patients

12. Patient deprived of liberty, under tutorship, guardianship or placed under judicial
protection

13. Patient is deemed incapable of giving informed consent

14. Patients who, for family, social, geographic or psychological reasons, cannot be
adequately followed up and/or are incapable of undergoing regular controls.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Salivary flow measure

Outcome Description:

The salivary flow is measured after stimulation with Parafilm at the time of inclusion and then 12 months after the end of radiotherapy.

Outcome Time Frame:

12 months after the end of radiotherapy

Safety Issue:

No

Principal Investigator

Renaud De Crevoisier, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Eugène Marquis - Rennes - France

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

2012-RdC-ORL-Th

NCT ID:

NCT01874587

Start Date:

June 2013

Completion Date:

January 2018

Related Keywords:

  • Oropharynx Cancer
  • Adaptative radiotherapy
  • oropharynx carcinoma
  • xerostomia
  • Carcinoma
  • Xerostomia
  • Oropharyngeal Neoplasms

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