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Squamous Cell Carcinoma of the Head and NeckPhase 2CisFRadNCT03330249

Comparison of Two Concomitant Administration of RT With Cisplatin in Standard Infusion or Fractional Infusion

A Phase 2 study testing Split Cisplatin, Cisplatin and Radiotherapy in people with Squamous Cell Carcinoma of the Head and Neck, run by Groupe Oncologie Radiotherapie Tete et Cou 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

The general aim is to compare the cumulative dose of cisplatin administered concomitantly with radiotherapy in reference arm A (cisplatin 100 mg / m2 day 1 every 21 days) and in the experimental arm B (Cisplatin split 25 mg / m2 / J D1 to D4 all 21 days). Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Split Cisplatin, Cisplatin and Radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
1 siteFrance
Study dates
3 Dec 2015to 10 May 2021
Phase
Phase 2
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

  • Squamous cell carcinoma of head and neck cancer stage III or IV: oral cavity, oropharynx, larynx or hypopharynx.
  • Patient non-operated and / or inoperable for reasons of non extirpabilité, local and regional expansion, general state or medical condition Or
  • Patient operated within 8 weeks before radiation therapy with a high risk of recurrence: unsatisfactory surgical margins (R1) and / or lymph node involvement with capsular rupture.
  • Activity Index according to WHO ≤ 2
  • Age ≤ 70 years
  • Ventricular ejection fraction left retained> 50%
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  • Renal allowing the administration of cisplatin: creatinine clearance> 60 ml / min (Cockroft formula)
  • Hematologic function allowing administration of CT: PNN> 1500, Pl> 100000, Hb> 9g
  • Satisfactory Liver function: SGOT and SGPT <3N; total bilirubin <20 mg / dL; INR <1.5; albumin> 30 g / l
  • Stomatological care adapted
  • Signature of informed consent
  • Bilateral neck irradiation Indication
  • Women and men of reproductive age should have accepted a medically effective contraception during the treatment period and at least 6 months after discontinuation of study treatment. If pregnancy is declared by a patient or partner of a patient, it must be followed for know the evolution of pregnancy.

Who cannot join

  • Cancers of the nasopharynx, sinus or nasal cavities
  • Histology other than squamous
  • Presence of distant metastases
  • Prior systemic chemotherapy (neoadjuvant)
  • Other concomitant cancer therapies
  • Presence of infection requiring the use of IV antibiotics including tuberculosis and HIV infection
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  • Coronary insufficiency, cardiac arrhythmias, uncontrolled or symptomatic heart failure
  • Uncontrolled hypertension
  • Peripheral neuropathy grade> 1
  • Vaccination against yellow fever and phenytoin recent or planned
  • History of cancer within 5 years prior to trial entry other than cutaneous basal cell carcinoma in situ or cervical
  • Pregnant woman capable of being or during lactation
  • Persons deprived of liberty, under guardianship
  • Inability to submit to medical monitoring testing for geographical, social or psychic
  • Unilateral cervical radiotherapy Indication

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre Paul Strauss

    Strasbourg, 67065

Other trials in France

About this study

Official title: Phase II Randomized Trial Comparating Two Concomitant Administration of Radiotherapy With Cisplatin in Patients With Not Operated or Inoperable HNSCC or With Recurrence High Risk in Adjuvant Postoperative Treatment

The general aim is to compare the cumulative dose of cisplatin administered concomitantly with radiotherapy in reference arm A (cisplatin 100 mg / m2 day 1 every 21 days) and in the experimental arm B (Cisplatin split 25 mg / m2 / J D1 to D4 all 21 days).

Read the detailed description

The standard treatment for squamous cell carcinoma of the head and neck locally advanced non-operated or non-operable is a combination of radiotherapy and concomitant chemotherapy. Indeed, the meta-analysis MACH showed for RT / CT associations an absolute survival benefit of 8% compared with radiotherapy alone. Cisplatin delivered optimally, ie at a dose of 100 mg / m2 on day 1, D22 and D43 of radiotherapy is as effective as combinations of cisplatin and 5-fluorouracil.

In post operative, treatment of high risk recurrence forms by Cisplatin, concomitantly with radiotherapy, also increases local control and overall survival.

However, it is an association whose toxicity is significant. The usual limiting toxicities were mucositis, dysphagia, nausea and vomiting with malnutrition and biologically kidney failure and myelotoxicity. Only 2/3 of the patients receive 3 cycles of cisplatin initially programmed.

As shown in the RTOG 0129 trial, the number of cycles of cisplatin and thus the cumulative dose of cisplatin administered concurrently with radiation therapy, significantly influences the locoregional control, progression free survival and overall survival.

One method of reducing the toxicity and thereby, increase the cumulative dose, would be to split the administration of cisplatin.

Moreover, the efficacy of Cisplatin, which only the free fraction is active, seems correlated with AUC that peak plasma which would in turn responsible for toxicity. The completion of a pharmacokinetic study comparing the AUC and Cmax obtained with cisplatin 100 mg / m2 and cisplatin fractionated is essential.

Finally, the limiting renal toxicity induced by cisplatin is currently diagnosed using the creatinine clearance. The Neutrophil gelatinase-associated lipocalin (NGAL) urinary is a new diagnosis and prognosis marker of renal impairment following treatment with cisplatin. However, further studies are needed to validate its clinical utility.

Being tested
Split Cisplatin, Cisplatin, Radiotherapy
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

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

  • Split CisplatinDrug

    Also called Cisplatin infusion

    25 mg/m2/day IV infusion at D1 to D4, at D22 to D25, at D43 to D46 during the radiotherapy.

  • CisplatinDrug

    Also called Cisplatin infusion

    100 mg/m2/day IV infusion at D1, D22 and D43 during the radiotherapy.

  • RadiotherapyRadiation

    Also called Radiotherapy IMRT with possibly integrated boost

    70 Gy in 35 fractions of 2 Gy in non-operated patients and 66 Gy in 33 fractions in post-operative.

Study groups in NCT03330249
Study groupRoleWhat they receive
Split Cisplatin and radiotherapyExperimental25 mg/m2/day IV infusion at D1 to D4, at D22 to D25, at D43 to D46 during the radiotherapy
Receives: Drug: Split Cisplatin; Radiation: Radiotherapy
Cisplatin and radiotherapyActive comparator100 mg/m2/day IV infusion at D1, D22 and D43 during the radiotherapy
Receives: Drug: Cisplatin; Radiation: Radiotherapy

What is being measured

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

  1. cumulative dose of administered cisplatin in each arm

    cisplatin dose amount received at each cycle

    Measured: 36 months after the end of treatment

Secondary outcomes (8)

  1. Frequency of toxicities

    Assessment of toxicity in accordance with NCI-CTC-AE 4.03

    Measured: Every week during treatment and every 3 months after treatment up to 3 years

  2. Maximum Platine Concentration [Cmax],

    Blood sample

    Measured: Cycle 1 before infusion, 90 min, 180 min,210 min, 270 min, 360 min and 420 min after the beginning of infusion in comparator arm and before infusion, 30 min, 45 min,75 min, 135 min, 225 min in experimental arm at Day 1 and Day 4

  3. Area Under the Curve [AUC] of platine

    Blood sample

    Measured: Cycle 1 before infusion, 90 min, 180 min, 210 min, 270 min, 360 min and 420 min after the beginning of infusion in comparator arm and before infusion, 30 min, 45 min, 75 min, 135 min, 225 min in experimental arm at Day 1 and Day 4

  4. Values of Neutrophil Gélatinase-associated Lipocalin (NGAL)

    Urinary sample

    Measured: Baseline and 24hour after infusion of cisplatin in comparator arm and 24hour after the last infusion of cisplatin in experimental arm

  5. Doses of radiation

    total dose received

    Measured: 7 weeks after the beginning of radiotherapy

  6. Duration of radiation

    Interruption of radiotherapy due to toxicity

    Measured: 7 weeks after the beginning of radiotherapy

  7. Loco-regional failure rate

    Delay between the date of randomisation and the occurrence of a recurrence

    Measured: 36 months after the end of randomization

  8. overall survival

    Delay between the date of randomization and death

    Measured: 36 months after the end of randomization

Timeline

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

  1. First posted6 Nov 2017
  2. Study start3 Dec 2015
  3. Primary completion10 May 2021
  4. Study completion10 May 2021

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03330249
Sponsor's protocol ID
GORTEC 2015-02
Acronym
CisFRad
Status last verified
Mar 2022
First submitted
17 Jan 2017
Last updated
11 Mar 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Split Cisplatin, Cisplatin and Radiotherapy in people with Squamous Cell Carcinoma of the Head and Neck, run by Groupe Oncologie Radiotherapie Tete et Cou 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 13 inclusion and 15 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 11 Mar 2022. 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 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.

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?

cumulative dose of administered cisplatin in each arm (time frame: 36 months after the end of treatment). 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 NCT03330249.

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 11 Mar 2022.

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