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

• Sponsor: Groupe Oncologie Radiotherapie Tete et Cou (Other)
• Overall Status: Completed
• CT.gov ID: NCT01864850
• Collaborator: Gustave Roussy, Cancer Campus, Grand Paris (Other)
• Enrollment: 202
• Locations: 2
• Arms: 2
• Actual Duration (Months): 79.6
• Patients Per Site: 101
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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 Design

• Study Type: Interventional
• Anticipated 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
• Actual Study Start Date: Oct 18, 2013
• Actual Primary Completion Date: Jun 1, 2020
• Actual Study Completion Date: Jun 5, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Locoregional control [6 months]

   Patient alive with locoregional control at 6 months after the end of radiotherapy

Secondary Outcome Measures

1. Acute toxicity [3 months]

   Acute toxicity according to the CTC NCI V4 - rate of toxicity by type and by grade

2. Late toxicity [18 months]

   Late toxicity according to the RTOG late toxicity scale - rate of toxicity by type and by grade

3. Autonomy [18 months]

   Autonomy according to ADL scale

4. Quality of life [18 months]

   Quality of life according to EORTC QLQ-C30 and QLQ-HN35

5. Overall survival [18 months]

   Overall survival

6. Locoregional progression [18 months]

   Locoregional progression

7. metastasis progression [18 months]

   metastasis progression

8. Progression free survival [18 months]

   Progression free survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 70 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Gustave Roussy	Villejuif		France	94805
2	Centre Hospitalier Princesse Grace	Monaco		Monaco	98 000

Sponsors and Collaborators

• Groupe Oncologie Radiotherapie Tete et Cou
• Gustave Roussy, Cancer Campus, Grand Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• GORTEC

Publications

None provided.

• Responsible Party: Groupe Oncologie Radiotherapie Tete et Cou
• ClinicalTrials.gov Identifier: NCT01864850
• Other Study ID Numbers: GORTEC ELAN-RT
• First Posted: May 30, 2013
• Last Update Posted: Apr 9, 2021
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Groupe Oncologie Radiotherapie Tete et Cou: HNSCC; Elderly; Geriatry
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck

Study Results

No Results Posted as of Apr 9, 2021