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Oropharyngeal Squamous Cell CarcinomaPhase 2CITHARENCT03623646

Cisplatin or ImmunoTHerapy in Association With Definitive Radiotherapy in HPV-related oropharyngEal Squamous Cell Carcinoma: a Randomized Phase II Trial.

A Phase 2 study testing Chemoradiotherapy arm and Immunotherapy + Radiotherapy arm in people with Oropharyngeal Squamous Cell Carcinoma, run by Institut Claudius Regaud at 2 sites 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

This study is a phase II, multicenter, open-label study that has been designed to evaluate the efficacy and the safety of definitive Radiotherapy (RT) (70 Gy) delivered in combination with the anti-PD-L1 Durvalumab immunotherapy in patients with Human Papilloma Virus (HPV)-related oropharyngeal squamous cell… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Oropharyngeal Squamous Cell Carcinoma
What is being tested?
Chemoradiotherapy arm and Immunotherapy + Radiotherapy arm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
2 sitesFrance
Study dates
15 Mar 2019to 14 Feb 2023
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Newly diagnosed, histologically proven squamous cell carcinoma of oropharynx T1 N1-N2 or T2-T3 N0 to N2 (AJCC 2018)
  • HPV positive status (positive staining for p16 in immunochemistry)
  • Presence of at least one measurable lesion according to RECIST v1.1 criteria (longest diameter recorded ≥10 mm with CT scan)
  • No prior anticancer therapy for OSCC
  • Patient eligible for definitive radiochemotherapy
  • Age ≥ 18 years
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  • WHO performance status < 2 i.e. 0 or 1
  • Body weight >30kg
  • Life expectancy more than 3 months
  • Adequate Hematology laboratory data within 6 weeks prior to start of treatment: Absolute neutrophils> 1.5 x 109/L, Platelets ≥ 100 x 109/L, Hemoglobin ≥ 9 g/dL
  • Adequate Biochemistry laboratory data within 6 weeks prior to start of treatment: Total bilirubin ≤ 1.5 x upper the normal limit, Transaminases ≤ 2.5 xUNL, Alkalin phosphatases ≤ 5 x UNL, Creatinin clearance ≥ 60 mL/min (Cockcroft), Glycemia ≤ 1.5 x UNL
  • Adequate Hemostasis laboratory data within 6 weeks prior to start of treatment: TP within the normal range
  • Women should be post-menopaused or willing to accept the use an effective contraceptive regimen during the treatment period and at least 3 months (durvalumab arm) or 6 months (cisplatin arm) after the end of the study treatment. All non-menopaused women should have a negative pregnancy test within 72 hours prior to registration. Men should accept to use an effective contraception during treatment period and at least 3 months (durvalumab arm) or 6 months (cisplatin arm) after the end of the study treatment
  • Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
  • Signed written informed consent

Who cannot join

  • T1 N0, T1-T3 N3, T4 N0-N3, p16 + OSCC
  • Previous treatment with another check-point inhibitor
  • Other histologies : UCNT, p16- SCCHN, sino-nasal tumors
  • Patient ineligible for Cisplatin according to the updated SmPC of the drug (including patient with auditory deficiency, patient with neuropathy induced by previous Cisplatin treatment or patient treated with prophylactic phenytoin)
  • Metastatic disease
  • Previous radiotherapy, except anterior strictly out of field radiotherapy, received for treatment of another primary tumor considered in remission in the past 5 years
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  • Participation in another therapeutic trial within the 30 days prior to entering this study
  • Uncontrolled disease such as diabetes, hypertension, symptomatic congestive heart or pulmonary failure, renal or hepatic chronic diseases... (non-exhaustive list)
  • Clinically significant cardiac disease or impaired cardiac function, such as:
  • Congestive heart failure requiring treatment (New York Heart Association (NYHA) Grade ≥ 2), left ventricular ejection fraction (LVEF) < 50% as determined by multi-gated acquisition (MUGA) scan or echocardiogram (ECHO), or uncontrolled arterial hypertension defined by blood pressure > 140/100 mm Hg at rest (average of 3 consecutive readings),
  • History or current evidence of clinically significant cardiac arrhythmias, atrial fibrillation and/or conduction abnormality, e.g. congenital long QT syndrome, high- Grade/complete AV-blockage
  • Acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass graft (CABG), coronary angioplasty, or stenting), < 3 months prior to screening
  • QT interval adjusted according to Fredericia (QTcF) > 470 msec on screening ECG
  • Current or prior use of immunosuppressive medication within 28 days before the first fraction of RT (exception: systemic corticosteroids at physiologic doses not exceeding 10 mg/day of prednisone or equivalent are allowed as well as steroids as premedication for hypersensitivity reactions (eg, CT scan premedication) - Topical, inhaled, nasal and ophthalmic steroids are not prohibited)
  • Active suspected or prior documented autoimmune disease (including inflammatory bowel disease, celiac disease, irritable bowel syndrome, Wegner's granulomatosis and Hashimoto's thyroiditis, diverticulitis with the exception of diverticulosis, systemic lupus erythematosus, Sarcoidosis syndrome). Note: participants with vitiligo or alopecia, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, patients with celiac disease controlled by diet alone, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger, are permitted to enroll
  • Known primary immunodeficiency or active HIV (positive HIV 1/2 antibodies)
  • Known active or chronic viral hepatitis or history of any type of hepatitis within the last 6 months indicated by positive test for hepatitis B surface antigen (HBV sAG) or hepatitis C virus ribonucleic acid (HCV antibody)
  • History of organ transplant requiring use of immunosuppressive medication
  • History of active tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice)
  • Current pneumonitis or interstitial lung disease
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
  • History of another primary malignancy except for:
  • Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
  • Adequately treated carcinoma in situ without evidence of disease
  • History of severe allergic reactions to any unknown allergens or any components of the study drug
  • History of leptomeningeal carcinomatosis
  • Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
  • Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician
  • Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician
  • Uncontrolled severe infectious disease, active hemorrhagic syndrome
  • Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP
  • Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
  • Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP
  • Vaccination for yellow fever
  • Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy or 180 days after the last dose of cisplatin

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • CHU Bordeaux

    Bordeaux

  • Institut Universitaire du Cancer Toulouse (IUCT-O)

    Toulouse, 31059

Other trials in France

About this study

This study is a phase II, multicenter, open-label study that has been designed to evaluate the efficacy and the safety of definitive Radiotherapy (RT) (70 Gy) delivered in combination with the anti-PD-L1 Durvalumab immunotherapy in patients with Human Papilloma Virus (HPV)-related oropharyngeal squamous cell carcinoma.

In this phase II trial, patients will be assigned in one of the two treatment arms:

  • Arm A (standard arm): Chemoradiotherapy arm
  • Arm B (Experimental arm): Immunotherapy + Radiotherapy arm

Total duration of treatment will be 6 months (at maximum in the experimental arm).

Patients will be followed for a maximum of 2 years following the date of randomization.

Being tested
Chemoradiotherapy arm, Immunotherapy + Radiotherapy arm
Keywords
Oropharyngeal Squamous Cell Carcinoma, Anti PD-L1, Durvalumab, Radiation therapy, Cisplatin, Human Papilloma Virus
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.

  • Chemoradiotherapy armDrug

    Radiation Therapy in combination with Chemotherapy (Cisplatin)

  • Immunotherapy + Radiotherapy armDrug

    Radiation Therapy in combination with Immunotherapy drug (Durvalumab)

Study groups in NCT03623646
Study groupRoleWhat they receive
Arm A (standard arm): Chemoradiotherapy armOtherNot described
Receives: Drug: Chemoradiotherapy arm
Arm B (Experimental arm): Immunotherapy + Radiotherapy armExperimentalNot described
Receives: Drug: Immunotherapy + Radiotherapy arm

What is being measured

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

  1. The rate of patients alive without progression at 12 months.

    Measured: 12 months for each patient

Secondary outcomes (5)

  1. Progression-free survival.

    Measured: 24 months for each patient

  2. Overall survival.

    Measured: 24 months for each patient

  3. Safety will be evaluated using National Cancer Institute Common Toxicity Criteria Adverse Event (NCI-CTCAE) version 4.03.

    Measured: 24 months for each patient

  4. Quality of life will be evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30).

    Measured: 24 months for each patient

  5. Quality of life will be evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Head & Neck 35 (EORTC QLQ-H&N35).

    Measured: 24 months for each patient

Timeline

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

  1. First posted9 Aug 2018
  2. Study start15 Mar 2019
  3. Primary completion26 Feb 2022
  4. Study completion14 Feb 2023

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
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03623646
Sponsor's protocol ID
18 VADS 06
Acronym
CITHARE
Status last verified
Jul 2025
First submitted
2 Aug 2018
Last updated
8 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chemoradiotherapy arm and Immunotherapy + Radiotherapy arm in people with Oropharyngeal Squamous Cell Carcinoma, run by Institut Claudius Regaud at 2 sites 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 15 inclusion and 36 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 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The rate of patients alive without progression at 12 months. (time frame: 12 months for each patient). 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 NCT03623646.

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 8 Aug 2025.

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