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Non Inferiority Trial of Standard RT Versus Hypofractionated Split Course in Elderly Vulnerable Patients With HNSCC (ELAN-RT)

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ClinicalTrials.gov Identifier: NCT01864850
Recruitment Status : Recruiting
First Posted : May 30, 2013
Last Update Posted : February 16, 2018
Sponsor:
Collaborator:
Gustave Roussy, Cancer Campus, Grand Paris
Information provided by (Responsible Party):
Groupe Oncologie Radiotherapie Tete et Cou

Brief Summary:
Randomized comparison between standard radiotherapy and hypofractionated split course schedule. Compared to standard radiotherapy, the investigators expect that hypofractionated split course (interruption of 2 weeks) radiotherapy will improve compliance to treatment, acute tolerance of treatment, preservation of autonomy, prevention of malnutrition, with the same efficacy, measured by the locoregional control rate.

Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinoma Radiation: Standard RT Radiation: Hypofractionated RT Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non Inferiority Randomized Trial of Standard Radiotherapy Versus Hypofractionated Split Course Radiotherapy in Elderly Vulnerable Patients With Inoperable Head and Neck Squamous Cell Carcinoma
Study Start Date : June 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard RT
70 Gy / 7 weeks / 2 Gy per fraction
Radiation: Standard RT
70 Gy / 7 weeks / 2 Gy per fraction

Experimental: Hypofractionated RT
55 Gy / 7 weeks with 2 weeks interruption / 3 Gy per fraction until 30 Gy, after interruption 2.5 Gy per fraction until 55 Gy
Radiation: Hypofractionated RT
55 Gy / 7 weeks with 2 weeks interruption / 3 Gy per fraction until 30 Gy, after interruption 2.5 Gy per fraction until 55 Gy




Primary Outcome Measures :
  1. Locoregional control [ Time Frame: 6 months ]
    Patient alive with locoregional control at 6 months after the end of radiotherapy


Secondary Outcome Measures :
  1. Acute toxicity [ Time Frame: 3 months ]
    Acute toxicity according to the CTC NCI V4 - rate of toxicity by type and by grade

  2. Late toxicity [ Time Frame: 18 months ]
    Late toxicity according to the RTOG late toxicity scale - rate of toxicity by type and by grade

  3. Autonomy [ Time Frame: 18 months ]
    Autonomy according to ADL scale

  4. Quality of life [ Time Frame: 18 months ]
    Quality of life according to EORTC QLQ-C30 and QLQ-HN35

  5. Overall survival [ Time Frame: 18 months ]
    Overall survival

  6. Locoregional progression [ Time Frame: 18 months ]
    Locoregional progression

  7. metastasis progression [ Time Frame: 18 months ]
    metastasis progression

  8. Progression free survival [ Time Frame: 18 months ]
    Progression free survival



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 70 or over
  • SIOG group 2 (vulnerable)
  • Life expectancy > 12 weeks
  • PS < 2
  • Histologically confirmed diagnosis of squamous cell carcinoma of head and neck: oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, cervical nodes (unknown primary).
  • First line treatment
  • At least one measurable lesion (RECIST)
  • Stage II to IV
  • Patients unsuitable for surgery of the primary tumour: non resectable tumor, anesthesia contra indication, patient's refusal, or organ sparing approach. Cervical nodes dissection authorized
  • Patients planned to be treated in a curative intent with radiotherapy alone on primary tumor site and on at least one head and neck node area
  • Consent form signed

Exclusion Criteria:

  • Primary squamous cell carcinoma of sinus, the skin or of the salivary glands
  • Stage I cancer
  • Radiotherapy planned on primary tumor only, or on neck nodes only. For patients with metastatic lymph nodes from unknown primary head and neck squamous cell carcinoma, patients will be excluded if head and neck mucosa (oropharynx, larynx, hypopharynx) is not included as a target volume for radiotherapy
  • Prior radiotherapy of head and neck area
  • Concurrent chemotherapy or immunotherapy or hormonotherapy
  • Induction chemotherapy
  • Concomitant infection requiring IV antibiotics
  • cancer other than head and neck cancer within the previous 5 years (baso cellular skin carcinoma and cervix carcinoma excepted)
  • conditions that could lead to bad compliance

Information from the National Library of Medicine

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): NCT01864850


Contacts
Contact: Cecile ORTHOLAN, MD cecile.ortholan@chpg.mc
Contact: Nadejda VINTONENKO, PhD gortec@orange.fr

Locations
France
Institut Gustave Roussy Recruiting
Villejuif, France, 94805
Contact: Yungan TAO, MD, PhD       yungan.tao@igr.fr   
Principal Investigator: Yungan TAO, MD,PhD         
Monaco
Centre Hospitalier Princesse Grace Recruiting
Monaco, Monaco, 98 000
Contact: Cecile ORTHOLAN, MD       cecile.ortholan@chpg.mc   
Principal Investigator: Cecile ORTHOLAN, MD         
Sponsors and Collaborators
Groupe Oncologie Radiotherapie Tete et Cou
Gustave Roussy, Cancer Campus, Grand Paris

Additional Information:
GORTEC  This link exits the ClinicalTrials.gov site

Responsible Party: Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier: NCT01864850     History of Changes
Other Study ID Numbers: GORTEC ELAN-RT
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data Monitoring Committee will meet every year either by a physical meeting or by conference call. Data on the recruitment, toxicity and autonomy are submitted every year.

Keywords provided by Groupe Oncologie Radiotherapie Tete et Cou:
HNSCC
Elderly
Geriatry

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site