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

Primary Purpose

HNSCC

Status

Recruiting

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Cisplatin

radiotherapy

About this trial

This is an interventional treatment trial for HNSCC focused on measuring salivary glands, sinus carcinoma, radiochemotherapy concomitant, cisplatin, protontherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

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.

Exclusion Criteria:

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
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.

Sites / Locations

Hôpital BéginRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Radiotherapy

Radiotherapy + concomitant cisplatin

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Progression-free survival

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

Secondary Outcome Measures

Overall Survival

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

Full Information

NCT ID

NCT02998385

First Posted

December 15, 2016

Last Updated

September 21, 2023

Sponsor

Groupe Oncologie Radiotherapie Tete et Cou

Collaborators

National Cancer Institute, France

1. Study Identification

Unique Protocol Identification Number

NCT02998385

Brief Title

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

Acronym

SANTAL

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 Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 20, 2017 (Actual)

Primary Completion Date

February 2030 (Anticipated)

Study Completion Date

March 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Groupe Oncologie Radiotherapie Tete et Cou

Collaborators

National Cancer Institute, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HNSCC

Keywords

salivary glands, sinus carcinoma, radiochemotherapy concomitant, cisplatin, protontherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

342 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Radiotherapy

Arm Type

Active Comparator

Arm Description

Arm Title

Radiotherapy + concomitant cisplatin

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

intravenous, concomitant to irradiation

Intervention Type

Radiation

Intervention Name(s)

radiotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression-free survival

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Overall Survival

Description

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

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Assessment of quality of Life: QLQC30 overall score

Description

Compare quality of life (QLQC30 overall score) between arms

Time Frame

From date of randomization to end of study or death or progression (the first occurred), assessed during 62 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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 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. Exclusion Criteria: 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 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

François Régis FERRAND, MD

Phone

+33 1 78 65 12 49

francoisregis.ferrand@gustaveroussy.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Juliette THARIAT, Prof

Phone

+33 02 51 45 50 50

j.thariat@baclesse.unicancer.fr

Facility Information:

Facility Name

Hôpital Bégin

City

Saint-Mandé

ZIP/Postal Code

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

François Régis FERRAND, MD

francoisregisferrand@gmail.com

First Name & Middle Initial & Last Name & Degree

Nicolas MEERT, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33756515

Citation

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.

Results Reference

derived

PubMed Identifier

33560478

Citation

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.

Results Reference

derived

Learn more about this trial

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

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