Back to results

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

Primary Purpose

Head and Neck Squamous Cell Carcinoma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Standard RT

Hypofractionated RT

About this trial

This is an interventional other trial for Head and Neck Squamous Cell Carcinoma focused on measuring HNSCC, Elderly, Geriatry

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Institut Gustave Roussy
Centre Hospitalier Princesse Grace

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard RT

Hypofractionated RT

Arm Description

70 Gy / 7 weeks / 2 Gy per fraction

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

Outcomes

Primary Outcome Measures

Locoregional control

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

Secondary Outcome Measures

Acute toxicity

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

Late toxicity

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

Autonomy

Autonomy according to ADL scale

Health related quality of life

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

Overall survival

Locoregional progression

metastasis progression

Progression free survival

Full Information

NCT ID

NCT01864850

First Posted

May 21, 2013

Last Updated

September 21, 2023

Sponsor

Groupe Oncologie Radiotherapie Tete et Cou

Collaborators

Gustave Roussy, Cancer Campus, Grand Paris

1. Study Identification

Unique Protocol Identification Number

NCT01864850

Brief Title

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

Acronym

ELAN-RT

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 Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

October 18, 2013 (Actual)

Primary Completion Date

June 2020 (Actual)

Study Completion Date

June 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Groupe Oncologie Radiotherapie Tete et Cou

Collaborators

Gustave Roussy, Cancer Campus, Grand Paris

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Squamous Cell Carcinoma

Keywords

HNSCC, Elderly, Geriatry

7. Study Design

Primary Purpose

Other

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Radiotherapy

Masking

None (Open Label)

Allocation

Randomized

Enrollment

202 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard RT

Arm Type

Active Comparator

Arm Description

70 Gy / 7 weeks / 2 Gy per fraction

Arm Title

Hypofractionated RT

Arm Type

Experimental

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

Standard RT

Intervention Description

70 Gy / 7 weeks / 2 Gy per fraction

Intervention Type

Radiation

Intervention Name(s)

Hypofractionated RT

Intervention Description

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 Measure Information:

Title

Locoregional control

Description

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Acute toxicity

Description

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

Time Frame

3 months

Title

Late toxicity

Description

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

Time Frame

18 months

Title

Autonomy

Description

Autonomy according to ADL scale

Time Frame

18 months

Title

Health related quality of life

Description

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

Time Frame

18 months

Title

Overall survival

Description

Overall survival

Time Frame

18 months

Title

Locoregional progression

Description

Locoregional progression

Time Frame

18 months

Title

metastasis progression

Description

metastasis progression

Time Frame

18 months

Title

Progression free survival

Description

Progression free survival

Time Frame

18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Institut Gustave Roussy

City

Villejuif

ZIP/Postal Code

94805

Country

France

Facility Name

Centre Hospitalier Princesse Grace

City

Monaco

ZIP/Postal Code

98 000

Country

Monaco

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Links:

URL

http://www.gortec.fr/

Description

GORTEC

Learn more about this trial

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

We'll reach out to this number within 24 hrs