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Lymphocyte-Sparing And Radio-Immunotherapy in Head and Neck Carcinoma

ConditionsOropharynx CancerLarynx CancerHypopharynx CancerPrimary Head and Neck Tumor
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Leon Berard

About this trial

The aim of this study is to investigate the effect of ATRA (Vesanoid) and the effect of tailored radiotherapy in patients with squamous cell carcinoma of the oropharynx, larynx or hypopharynx.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

the oropharynx p16-, larynx or hypopharynx : T1/N2a-N2b, T2/N0-N2b, T3/N0-N2b (UICC 8th Ed.), or

the oropharynx p16+ : T1/N1 (multiple nodes), T2-T3/N0-N1 (UICC 8th Ed.).

Neutrophils count > 1.5 × 109 /L

Platelets count > 75 × 109 /L

Disqualifiers

Severe infection within 4 weeks prior to randomisation, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia,

Active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test at screening),

Active hepatitis C. Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV RNA at screening,

HIV infection,

Trial design

Design model

Factorial

Treatments tested in this trial

  • Vesanoid

    Drug

    Before (chemo)radiotherapy: D1 to D3: 150mg/m2/day, 1 week before radiotherapy. Post (chemo)radiotherapy: D1 to D3: 150mg/m2/day every 3 weeks for up to 4 cycles post (chemo)radiotherapy

  • Standard radiotherapy

    Radiation

    70 Gy in 35 fractions of 2 Gy over 6 (6 fractions per week) or hyperfractionated RT with a median therapeutic dose of 80.5 Gy delivered in 70 fractions of 1.15 Gy over 7 weeks.

  • Tailored radiotherapy

    Radiation

    70 Gy in 35 fractions of 2 Gy over 6 weeks (6 fractions per week) or hyperfractionated RT with a median therapeutic dose of 80.5 Gy delivered in 70 fractions of 1.15 Gy over 7 weeks.

  • Cisplatin

    Drug

    Cisplatin is recommended for the following patients : Stage T1-T2/N2a-N2b and T3/N0-N1-N2a-N2b. concomitant chemotherapy is standard of care treatments and should be administered as per standard practice. Chemotherapy will include one of the two cisplatin regimens specified in this protocol at the discretion of the participating centers. The centers must however treat all their recruited patients with one of the two regimens chosen before site activation. Chemotherapy should start the first day of radiotherapy. Cisplatin should be infused before radiation therapy delivery. The 2 options are: • Cisplatin 100 mg/m² i.v. on day 1 and 22 of radiotherapy (when 70 Gy are delivered in 6 weeks) or on day 1, 22 and 43 (when 70 Gy are delivered in 7 weeks). or • Cisplatin 40 mg/m² i.v. on day 1, 8, 15, 22, 29, 35 of radiotherapy (when 70 Gy are delivered in 6 weeks) or on day 1, 8, 15, 22, 29, 35, 42 of radiotherapy (when 70 Gy are delivered in 7 weeks).

  • Cetuximab

    Drug

    Cetuximab is recommended for the following patients : Stage T1-T2/N2a-N2b and T3/N0-N1-N2a-N2b. concomitant Cetuximab is standard of care treatments and should be administered as per standard practice. Cetuximab therapy will be started with an intravenous loading dose of 400 mg/m2 one week before start of RT followed by six (radiotherapy over 6 weeks) or seven (radiotherapy over 7 weeks) weekly doses of 250 mg/m2.

Treatment groups

460 Participants
are divided into 4 treatment groups
Group A: Standard radiotherapyActive comparator 3 interventions
Group B: Tailored radiotherapy and ATRA (Vesanoid)Experimental treatment 4 interventions
Group C: Standard radiotherapy and ATRA (Vesanoid)Experimental treatment 4 interventions
Group D: Tailored radiotherapyExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Event Free Survival (EFS)

Event free survival (EFS) is defined as the time from randomisation to apparition of a documented relapse either local or regional or distant according to clinical or radiological assessment, or persistent residual disease including pathologically positive neck node, or death due to any cause.

Time frame
At 6, 9, 15, 21 and 27 months from randomisation then annually assessed up to 2 years

Secondary outcomes

1

Local relapse Free Survival

Local relapse Free Survival (lrFS, at site of primary tumor) is defined as the delay from randomisation to first local relapse (i.e. primary site) or death. Patients without documented event will be censured at the last adequate visit or tumor evaluation.

Time frame
At 6, 9, 15, 21 and 27 months from randomisation then annually assessed up to 2 years
2

Regional relapse Free survival

Regional relapse Free survival (rrFS, in the neck) is defined as the delay from randomisation to first regional relapse (i.e. neck) or death.

Time frame
At 6, 9, 15, 21 and 27 months from randomisation then annually assessed up to 2 years
3

Metastasis Free Survival

Metastasis Free Survival (mFS) is the time between randomisation and apparition of first metastasis (date of metastatic diagnosis). Patients without documented event will be censured at the last tumour evaluation.

Time frame
At 6, 9, 15, 21 and 27 months from randomisation then annually assessed up to 2 years
4

Rate of pathologically positive lymph nodes

Rate of pathologically positive lymph nodes at neck node dissection performed at 4 months after the completion of (chemo)-radiotherapy for those patients benefiting from a neck node dissection

Time frame
At 4 months from the completion of (chemo)-radiotherapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Leon Berard

Lead sponsor

Source ClinicalTrials.gov
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