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NCT02998385Active, not recruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 7 May 2025

Brief summary (registry, in English)

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)

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
342 (estimated)
First submitted
15 Dec 2016
Start date
20 Jan 2017
Primary completion date
Feb 2030
Lead sponsor
Groupe Oncologie Radiotherapie Tete et Cou
NCT number
NCT02998385

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 342
  • From 20 Jan 2017 to the primary completion date, Feb 2030
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • History of radiotherapy in the ENT region and/or neoadjuvant chemotherapy for the pathology concerned
  • Allergy to cisplatin and/or its excipients
  • Other cancer, except for cancer in situ of the cervix, skin Carcinoma (except melanoma) or cancer controlled for more than 5 years

Lab values

  • 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.

Other

  • Synchronous metastases
  • Contraindications for administration of cisplatin or carboplatin
  • Vaccination against yellow fever, recent or planned
  • Administration of phenytoin with prophylactic purpose
  • 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.

Who the study is looking for

  • \- 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)
  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hôpital Bégin
Coordinator of this site? Confirm its status
Saint-MandéFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.