NCT01864850

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2013

Longer than P75 for phase_3

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 30, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

October 18, 2013

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2020

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

6.6 years

First QC Date

May 21, 2013

Last Update Submit

September 21, 2023

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

HNSCCElderlyGeriatry

Outcome Measures

Primary Outcomes (1)

  • Locoregional control

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

    6 months

Secondary Outcomes (8)

  • Acute toxicity

    3 months

  • Late toxicity

    18 months

  • Autonomy

    18 months

  • Health related quality of life

    18 months

  • Overall survival

    18 months

  • +3 more secondary outcomes

Study Arms (2)

Standard RT

ACTIVE COMPARATOR

70 Gy / 7 weeks / 2 Gy per fraction

Radiation: Standard RT

Hypofractionated RT

EXPERIMENTAL

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

Interventions

Standard RTRADIATION

70 Gy / 7 weeks / 2 Gy per fraction

Standard RT
Hypofractionated RTRADIATION

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

Hypofractionated RT

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institut Gustave Roussy

Villejuif, 94805, France

Location

Centre Hospitalier Princesse Grace

Monaco, 98 000, Monaco

Location

Related Links

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Radiotherapy
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2013

First Posted

May 30, 2013

Study Start

October 18, 2013

Primary Completion

June 1, 2020

Study Completion

June 5, 2020

Last Updated

September 22, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

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.

Locations

FR(1)MO(1)