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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 : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Groupe Oncologie Radiotherapie Tete et Cou

Tracking Information
First Submitted Date  ICMJE December 15, 2016
First Posted Date  ICMJE December 20, 2016
Last Update Posted Date January 18, 2020
Study Start Date  ICMJE November 2016
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2016)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 15, 2020)
Assessment of quality of Life: QLQC30 overall score [ 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
Original Other Pre-specified Outcome Measures
 (submitted: December 16, 2016)
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
 
Descriptive Information
Brief Title  ICMJE Chemo-radiotherapy Versus Radiotherapy in the Treatment of Salivary Glands and Nasal Tumors (IMRT or Protontherapy)
Official Title  ICMJE A Phase III Randomized Study of Chemo-radiotherapy Versus Radiotherapy Alone in the Adjuvant Treatment of Salivary Glands and Nasal Tumors (IMRT or Protontherapy)
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)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HNSCC
Intervention  ICMJE
  • Drug: Cisplatin
    intravenous, concomitant to irradiation
  • Radiation: radiotherapy
Study Arms  ICMJE
  • 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.

    Intervention: 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

    Interventions:
    • Drug: Cisplatin
    • Radiation: radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 16, 2016)
260
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2026
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: François Régis FERRAND +33 1 43 98 50 78 francoisregisferrand@gmail.com
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02998385
Other Study ID Numbers  ICMJE GORTEC 2016-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Groupe Oncologie Radiotherapie Tete et Cou
Study Sponsor  ICMJE Groupe Oncologie Radiotherapie Tete et Cou
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Groupe Oncologie Radiotherapie Tete et Cou
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP