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

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ClinicalTrials.gov Identifier: NCT02998385
Recruitment Status : Recruiting
First Posted : December 20, 2016
Last Update Posted : December 31, 2018
Sponsor:
Information provided by (Responsible Party):
Groupe Oncologie Radiotherapie Tete et Cou

Brief 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 mg/m2 IV on day 1 - J22 - 43 (3 cycles)

Condition or disease Intervention/treatment Phase
HNSCC Drug: Cisplatin Radiation: radiotherapy Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : November 2016
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Arm Intervention/treatment
Active Comparator: Radiotherapy

Arm 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.

Radiation: radiotherapy
Experimental: Radiotherapy + concomitant cisplatin

Arm 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

Drug: Cisplatin
intravenous, concomitant to irradiation

Radiation: radiotherapy



Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: From date of randomization to date of disease progression or death, which occur first, assessed during 62 months ]
    Compare progression-free survival between the 2 treatment arms: radiation therapy alone versus radiochimiotherapy in adjuvant patients treatment operated.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: From date of randomization to date of death, assessed during 62 months ]
    Compare the 2 arms of treatment in operated patients in terms of overall survival


Other Outcome Measures:
  1. Quality of Life [ Time Frame: From date of randomization to end of study or death or progression (the first occurred), assessed during 62 months ]
    Compare quality of life (QLQC30 overall score) between arms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- 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 major salivary glands (Parotid, submandibular and sublingual glands) and accessories with the following histologies: adenoid cystic Carcinoma, adenocarcinoma without another indication (SAI) of high-grade, muco-epidermoid of intermediate grade or high grade Carcinoma, salivary ductal carcinoma, carcinomas to turn cells (with dedifferencie contingent or Ki 67 > 10%), Sebaceous Carcinoma, large cell carcinoma, small cell carcinomas Mucinous adenocarcinoma, carcinoma on massively invasive Pleomorphic adenoma, oncocytic carcinomas, myoepithelial Carcinoma

or

Malignant tumors of the sinus with the following histology: adenocarcinomas of the ethmoid (ADE) of bowel and no intestinal type, CF adenoids carcinomas and other carcinomas of salivary origin (COS).

  • 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
  • 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.

Exclusion Criteria:

  • History of radiation therapy in the ENT area
  • Synchronous metastases
  • Contraindications for administration of cisplatin or carboplatin
  • Allergy to cisplatin and/or its excipients
  • Melanoma, lymphoma, tumors of mesenchymal (of type Sarcoma), epidermoid carcinomas, (SCUNC) neuroendocrine carcinomas and carcinoma undifferentiated (SNUC), nasopharyngeal carcinomas type 1, 2, and 3.
  • Vaccination against yellow fever, recent or planned
  • Administration of phenytoin with prophylactic purpose
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02998385


Contacts
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Contact: François Régis FERRAND +33 1 43 98 50 78 francoisregisferrand@gmail.com

Locations
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France
Hôpital Bégin Recruiting
Saint-Mandé, France, 94
Contact: François Régis FERRAND, MD       francoisregisferrand@gmail.com   
Sponsors and Collaborators
Groupe Oncologie Radiotherapie Tete et Cou

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Responsible Party: Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier: NCT02998385     History of Changes
Other Study ID Numbers: GORTEC 2016-02
First Posted: December 20, 2016    Key Record Dates
Last Update Posted: December 31, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Groupe Oncologie Radiotherapie Tete et Cou:
salivary glands
sinus carcinoma
radiochemotherapy concomitant
cisplatin
protontherapy

Additional relevant MeSH terms:
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Cisplatin
Antineoplastic Agents