AzTrials
AzTrials

Squamous Cell CarcinomaPhase 2/3JANORL2NCT01211938

Trial Comparing Two Protocols of re Irradiation in an Irradiated Area for Carcinoma of the Upper Aerodigestive Tract

A Phase 2/3 study testing single-fraction radiotherapy with concomitant 5FU and Hydrea and hyperfractionated radiotherapy with concomitant Cetuximab in people with Squamous Cell Carcinoma, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients will be randomised after surgery, provided surgery is macroscopically adequate, that there is a flap of tissue protecting the vascular axis and that wound healing allows reirradiation to begin less than 8 weeks after surgery.Reirradiation will begin in the two arms less than 8 weeks after surgery in the… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Squamous Cell Carcinoma
What is being tested?
single-fraction radiotherapy with concomitant 5FU and Hydrea and hyperfractionated radiotherapy with concomitant Cetuximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteFrance
Study dates
15 Jun 2010to 25 Feb 2017
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Recurrent or second upper aerodigestive tract carcinoma in an area previously irradiated at a dose of >= 50 Gy
  • Squamous cell carcinoma
  • No grade III or IV sequels linked to the first radiation therapy (excepted radiation sequels of salivary glands)
  • Relapse or second carcinoma (clinically invasive and/or lymph node recurrence >= 3 cm and/or the association of a local and lymph node recurrence
  • Oral cavity, pharynx, larynx (if rT4), cervical region (if >3cm)
  • No distant metastases confirmed by chest CT scan, abdominal ultrasound (or CT scan) in case of abnormal liver function, and bone scintigraphy in case of local symptoms
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  • Surgery in the previously irradiated region allowing a macroscopically adequate resection
  • Surgery and vascular protection with a myocutaneous or free flap
  • Interval > = 6 months between the end of the first radiation treatment and surgery in the previously irradiated area
  • Wound healing allowing reirradiation within an interval of 8 weeks after surgery in the previouly irradiated area.
  • No participation in a clinical trial during the 30 days preceding inclusion
  • Age between 18 et 70 years.
  • Performance Status 0 or 1 according to WHO criteria.
  • Hematological function : neutrophils * 2 x 106/l, platelets : * 100 x 106/l, hemoglobin : * 10 g/dl (or 6.2 mmol/l)
  • Liver function : total bilirubin (normal) ; ASAT (SGOT) and ALAT (SGPT) * 2.5 * upper limit of normal (ULN) in each centre ; alkaline phosphatases * 5 * ULN. Patients whose ASAT or ALAT levels > 1.5 * ULN associated with alkaline phosphatases * 2.5 * ULN are not eligible for the trial
  • Renal function : serum creatinine * 120 *mol/l (1.4 mg/dl) ; if creatinine level is > 120 *mol/l, creatinine clearance should be * 60 ml/min.
  • Written consent of participants

Who cannot join

  • Superficial recurrence not associated with a lymph node relapse, isolated lymph node recurrence measuring less than 3 cm
  • Distant metastases
  • Grade 3 or 4 sequels of first radiation therapy (excepted salivary gland sequels)
  • Macroscopically inadequate surgery
  • Delay in wound healing obliging reirradiation to be postponed beyond 8 weeks.
  • > Grade 3 Toxicity induced by chemotherapy administered during a previous treatment
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  • Hypersensitivity to Erbitux
  • Concomitant severe comorbidities (non exhaustive list)
  • Unstable cardiac comorbidity in spite of treatment.
  • Neurological or psychiatric history such as dementia, convulsions.
  • Severe uncontrolled infection
  • Obstructive bronchopneumopathy which required hospitalisation during the year preceding inclusion.
  • Factors (psychological, familial, social or geographic) likely to hinder patient compliance with the study protocol and follow-up are considered exclusion criteria. These factors should be discussed with the patient before enrollment in the trial
  • Women who are pregnant, breast-feeding or of birthgiving age without effective contraception

Trial locations and contacts

1 site in 1 country.

France1 site

  • Institut Gustave Roussy

    Villejuif, 94800

Other trials in France

About this study

Official title: Randomized Phase 2 Trial Evaluating the Acute Toxicity of Two Protocols of Reirradiation After Surgery in an Irradiated Area for Carcinoma of the Upper Aerodigestive Tract - Single-fraction Radiotherapy With Concomitant 5FU and Hydrea Administered Every Other Week - Continuous Hyperfractionated Radiotherapy With Concomitant Cetuximab

Patients will be randomised after surgery, provided surgery is macroscopically adequate, that there is a flap of tissue protecting the vascular axis and that wound healing allows reirradiation to begin less than 8 weeks after surgery.Reirradiation will begin in the two arms less than 8 weeks after surgery in the irradiated area. The reirradiated volume : tumour bed + a safety margin of < 2 cm with immediate protection of bone marrow. This volume should be jointly defined by the radiotherapist and the surgeon. During reirradiation, 60 Gy will be delivered in the two arms but will last 11 weeks in the reference arm and 5 weeks in the investigational arm.Acute toxicity (NCI-CTCAE) will be evaluated at the end of reirradiation and at 6 months from randomization (first follow-up consultation)

Being tested
single-fraction radiotherapy with concomitant 5FU and Hydrea, hyperfractionated radiotherapy with concomitant Cetuximab
Keywords
phase II/III, upper aerodigestive tract carcinoma, re irradiation, Recurrent or second upper aerodigestive tract carcinoma
Medical subject headings
Carcinoma, Squamous Cell, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • single-fraction radiotherapy with concomitant 5FU and HydreaRadiation

    single-fraction radiotherapy with concomitant 5FU and Hydrea

  • hyperfractionated radiotherapy with concomitant CetuximabRadiation

    hyperfractionated radiotherapy with concomitant Cetuximab

Study groups in NCT01211938
Study groupRoleWhat they receive
single-fraction radiotherapy with concomitant 5FU and HydreaActive comparatorsix 5-day cycles with a 9-day rest period between each cycle (split course). Each cycle includes : a single-fraction at a dose of 2 Gy per session for 5 sessions, combined with 5FU (800 mg/m2/day) and Hydrea (500 mg x 3/day) over the 5 days of the cycle. The total dose of radiotherapy is therefore 60 Gy delivered over 11 weeks.
Receives: Radiation: single-fraction radiotherapy with concomitant 5FU and Hydrea
hyperfractionated radiotherapy with concomitant CetuximabExperimentalBifractionated radiotherapy at a dose of 1.2 Gy per session at a rate of 2 sessions per day, at least 6h apart, 5 days per week over 5 weeks, without a split course, combined with Cetuximab. The total dose of radiotherapy is 60 Gy delivered over 5 weeks. Cetuximab (ErbituxÒ) is to be administered in a 2-hour IV infusion at a dose of 400 mg/m2, 8 days before the start of radiotherapy, then in a 1-hour infusion at a dose of 250 mg/m2 on days 1, 8, 15, 22 and 29 of radiotherapy.
Receives: Radiation: hyperfractionated radiotherapy with concomitant Cetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acute toxicity requiring an interruption of radiotherapy for more than 2 weeks

    Measured: 6 months

  2. Overall survival at 3 years and loco-regional control at 3 years

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2010 (estimated)
  2. Study start15 Jun 2010
  3. Primary completion25 Feb 2017
  4. Study completion25 Feb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01211938
Sponsor's protocol ID
CSET 1542-JANORL2
Other IDs
2009-017047-34, 2009
Acronym
JANORL2
Status last verified
Aug 2026
First submitted
29 Sep 2010
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Tao Y, Faivre L, Laprie A, Boisselier P, Ferron C, Jung GM, Racadot S, Gery B, Even C, Breuskin I, Bourhis J, Janot F. Randomized trial comparing two methods of re-irradiation after salvage surgery in head and neck squamous cell carcinoma: Once daily split-course radiotherapy with concomitant chemotherapy or twice daily radiotherapy with cetuximab. Radiother Oncol. 2018 Sep;128(3):467-471. doi: 10.1016/j.radonc.2018.05.005. Epub 2018 May 18.

    PubMed 29784451

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing single-fraction radiotherapy with concomitant 5FU and Hydrea and hyperfractionated radiotherapy with concomitant Cetuximab in people with Squamous Cell Carcinoma, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute toxicity requiring an interruption of radiotherapy for more than 2 weeks (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01211938, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

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