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HNSCCPhase 3SANTALNCT02998385

Chemo-radiotherapy Versus Radiotherapy in the Treatment of Salivary Glands and Nasal Tumors (IMRT or Protontherapy)

A Phase 3 study testing Cisplatin and radiotherapy in people with HNSCC, run by Groupe Oncologie Radiotherapie Tete et Cou at 1 site in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

A phase III, multicenter, randomized, open-label, french study comparing: Arm A : Radiotherapy alone (66 to 70 Gy; 5 fractions/week; 1fraction/day; 2 Gy/fraction) (IMRT or protontherapy) Arm B: Radiotherapy (66 to 70 Gy; 5 fractions/week; 1fraction/day; 2 Gy/fraction; IMRT or protontherapy) + concomitant cisplatin 100… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HNSCC
What is being tested?
Cisplatin and radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
342 participants
Where
1 siteFrance
Study dates
20 Jan 2017to Mar 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Resected tumors of the sinus or the salivary glands T3-4, N1-3 or T1-2 N0, with overgrown banks or positive margins (< 5 mm)
  • or
  • Unresectable or not operable tumors of salivary glands or sinuses
  • Carcinomas of the main salivary glands (parotid, submandibular or sublingual glands) and accessories or Malignant sinus tumors with any histological type except melanoma, lymphoma, mesenchymal tumor (sarcoma type), squamous cell carcinoma and nasopharyngeal carcinoma type 1, 2, 3.
  • Age ≥ 18 years
  • Performance status 0 -2 (WHO criteria)
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  • For patients ≥ 70 years, the score to the G8 questionnaire must be > 14 with no fall in the previous 12 months or with a geriatric assessment consistent with the administration of chemotherapy
  • Estimated life expectancy greater than or equal to 6 months
  • Neutrophils > 1.5 x 109/l, platelets > 100 x 109/l, hemoglobin ≥ 9.5 g/dl, bilirubin ≤ 3 x upper normal value (ULN), AST/ALT < 5 ULN, PAL < 3 ULN
  • Creatinin Clearance ≥ 60 mL/min (Cockroft formula)
  • Adequate cardiac function according to the investigator, compatible with the administration of cisplatin 100 mg/m²
  • Affiliation to a social insurance or beneficiary of such a regimen
  • Patient having given his written consent signed before any study specific procedure.

Who cannot join

  • History of radiotherapy in the ENT region and/or neoadjuvant chemotherapy for the pathology concerned
  • Synchronous metastases
  • Contraindications for administration of cisplatin or carboplatin
  • Allergy to cisplatin and/or its excipients
  • Vaccination against yellow fever, recent or planned
  • Administration of phenytoin with prophylactic purpose
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  • Other cancer, except for cancer in situ of the cervix, skin Carcinoma (except melanoma) or cancer controlled for more than 5 years
  • Pregnant, breastfeeding or without birth control woman. Woman having the ability to procreate should have (serum or urinary) negative pregnancy test within 14 days prior to study treatment decision-making. (Men or women) patients should use a reliable contraceptive method throughout the treatment and at least 6 months after the end of chemotherapy.
  • Persons deprived of liberty under supervision or under curatorship, or unable to adhere to medical follow-up of the study for geographical, social or psychological reasons.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hôpital Bégin

    Saint-Mandé, 94

Other trials in France

About this study

Official title: A Phase III Randomized Study of Chemo-radiotherapy Versus Radiotherapy Alone in the Adjuvant Treatment of Salivary Glands and Nasal Tumors (IMRT or Protontherapy)

A phase III, multicenter, randomized, open-label, french study comparing:

  • Arm A : Radiotherapy alone (66 to 70 Gy; 5 fractions/week; 1fraction/day; 2 Gy/fraction) (IMRT or protontherapy)
  • Arm B: Radiotherapy (66 to 70 Gy; 5 fractions/week; 1fraction/day; 2 Gy/fraction; IMRT or protontherapy) + concomitant cisplatin 100 mg/m2 IV on day 1 - J22 - 43 (3 cycles)
Read the detailed description

Carcinomas of the sinuses and the salivary glands are rare. They are heterogeneous in terms of anatomical sites and histology subtypes. For this reason and in the absence of prospective study, their treatment is still largely extrapolated from data of frequent carcinomas of the upper digestive tract. These tumors are most often diagnosed lately. Their treatment is based on a multimodal management of care, with a central place for the surgery and radiotherapy (Proof level Grade C). Despite the advances in surgical techniques, and the addition of radiation therapy, the 5-year overall survival probability does not exceed 65% mainly due to a loco regional development.

In this context, a chemotherapy administered concomitantly to radiotherapy, could increase the efficacy of the locoregional treatment by a radiosensibilization process and regardless of the histology. This point is regularly discussed in multidisciplinary concertation meeting, including bi-monthly national REFCOR meeting (network of French Expertise on rare Cancers of the head and neck). At present, the lack of data brings even to discuss the addition of cisplatin to exclusive irradiation of unresectable or not operable tumors.

No randomized study has been published in this context. The first comparative prospective study addressing the addition of weekly cisplatin to the adjuvant irradiation of salivary, is a phase II randomized study (Radiation Therapy Oncology Group - RTOG 1008) currently enrolling patients in the United States of America.

The Sponsor propose to conduct a phase III randomized study evaluating the impact of the addition of cisplatin to a treatment by radiotherapy in adjuvant setting (≥ 65 Gy) in case of a high risk of recurrence: case of radioresistant histologies (e.g. cystic fibrosis adenoids carcinomas), or case of unfavourable histo-prognostic criteria (incomplete resection, presence of emboli, etc.) in this population.

Conditions
HNSCC
Being tested
Cisplatin, radiotherapy
Keywords
salivary glands, sinus carcinoma, radiochemotherapy concomitant, cisplatin, protontherapy
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.

  • CisplatinDrug

    intravenous, concomitant to irradiation

  • radiotherapyRadiation

    66 à 70 Gy per fractions of 2 Gy, 1 fraction/day, 5 fractions/week

Study groups in NCT02998385
Study groupRoleWhat they receive
RadiotherapyActive comparatorArm A Radiation therapy: 66 to 70 Gy in fractions of 2 Gy, 1 fraction/day, 5 fractions per week. Radiation therapy will be conducted by conformational intensity modulation radiotherapy (IMRT) or protontherapy. Irradiation by 3D conformational radiotherapy can be discussed on a case by case with the Intergroup Coordinator GORTEC.
Receives: Radiation: radiotherapy
Radiotherapy + concomitant cisplatinExperimentalArm B Concomitant systemic treatment with cisplatin + radiotherapy According to standard protocol of concomitant cisplatin 100 mg/m2 IV on day 1 - J22 - 43 (3 maximum cycles). Radiation therapy: 66 to 70 Gy in fractions of 2 Gy, 1 fraction/day, 5 fractions per week. Radiation therapy will be conducted by conformational intensity modulation radiotherapy (IMRT) or protontherapy. Irradiation by 3D conformational radiotherapy can be discussed on a case by case with the Intergroup Coordinator GORTEC
Receives: Drug: Cisplatin; Radiation: radiotherapy

What is being measured

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

  1. Progression-free survival

    Compare progression-free survival between the 2 treatment arms: radiation therapy alone versus radiochimiotherapy in adjuvant patients treatment operated.

    Measured: From date of randomization to date of disease progression or death, which occur first, assessed during 62 months

Secondary outcomes (1)

  1. Overall Survival

    Compare the 2 arms of treatment in operated patients in terms of overall survival

    Measured: From date of randomization to date of death, assessed during 62 months

Timeline

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

  1. First posted20 Dec 2016 (estimated)
  2. Study start20 Jan 2017
  3. Primary completionFeb 2030 (estimated)
  4. Study completionMar 2030 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
342 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02998385
Sponsor's protocol ID
GORTEC 2016-02
Acronym
SANTAL
Status last verified
May 2025
First submitted
15 Dec 2016
Last updated
7 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ferrari M, Orlandi E, Bossi P. Sinonasal cancers treatments: state of the art. Curr Opin Oncol. 2021 May 1;33(3):196-205. doi: 10.1097/CCO.0000000000000726.

    PubMed 33756515

  • Joshi NP, Broughman JR. Postoperative Management of Salivary Gland Tumors. Curr Treat Options Oncol. 2021 Feb 9;22(3):23. doi: 10.1007/s11864-021-00820-9.

    PubMed 33560478

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cisplatin and radiotherapy in people with HNSCC, 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 9 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: under way, not looking for participants, as of the sponsor's last update on 7 May 2025. 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 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?

This study is still under way. Results are not available in the source record yet.

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?

Progression-free survival (time frame: From date of randomization to date of disease progression or death, which occur first, assessed during 62 months). 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 NCT02998385, which also lists 2 linked publications.

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 7 May 2025.

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