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Completed

NCT Number: NCT01874587

Adaptative Radiotherapy to Decrease Xerostomia in Oropharynx Carcinoma

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 arc-IMRT treatment arms will be compared: one "standard" arm based on the use of a single pre-treatment planning and one "experimental" arm (adaptive RT) based on a weekly replanning to spare the salivary glands. The main objective is to increase by 25% the salivary flow (Parafilm) 12 months after RT thanks to adaptive RT, while not decreasing local control. The secondary objectives are to increase the salivary flow (scintigraphy), reduce xerostomia, acute and late toxicities (Eisbruch questionnaire, MDAS-HN, v.4 CTCAE), while maintaining local control (stopping rule of the trial if difference>15%). 174 patients will be included in 6 French centers for 2 years and followed for 2 years. The HPV (Human Papillomavirus) status will be identified and the tumors frozen. A central IMRT QA (Quality Assurance) will be performed.

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Key information

Conditions

Oropharynx Cancer Head and Neck Neoplasms Mouth Diseases Neoplasms Neoplasms by Site Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Salivary Gland Diseases Stomatognathic Diseases Xerostomia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinique Claude Bernard, Albi, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

adaptative radiotherapy

Radiation

weekly replanning

Primary outcomes

  1. Salivary flow measure

    Time frame: 12 months after the end of radiotherapy

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

Secondary outcomes

  1. Xerostomia

    Time frame: From before treatment to 24 months after the end of radiotherapy

    salivary flow measured after stimulation before treatment, 6months, 18 months and 24 months after the end of radiotherapy Eisbruch's questionnaire before treatment, at 3, 6, 12, 18 and 24 months after the end of radiotherapy

  2. Salivary flow

    Time frame: Before treatment and 12 months after the end of radiotherapy

    measured by scintigraphy

  3. Local control

    Time frame: 2 years

    analysed according stages T and N, HPV status

  4. Early and late toxicities

    Time frame: From beginning of the radiotherapy up to 2 years after the end of radiotherapy

    early toxicity : weekly assessment during radiotherapy until 3 months after the end late toxicity : 6, 12, 18 and 24 months after the end of radiotherapy

  5. Survival

    Time frame: 2 years

    overall and disease free survival

  6. Head and Neck functionality

    Time frame: Before treatment to 24 months after the end of radiotherapy

    MDASI-HN questionnaire before treatment, 3, 6, 12, 18 and 24 months after the end of radiotherapy

Sponsors and collaborators

Lead sponsor

Center Eugene Marquis

Other

Registry information

Official study title

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

Acronym: ARTIX

Important dates

Study start
2013
Primary completion
2019
Study completion
2020
First posted
Jun 11, 2013
Registry last updated
Jul 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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