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Trial of Laryngeal Preservation Comparing Induced CT Followed by RT vs CT Concomitant to RT (SALTORL)

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ClinicalTrials.gov Identifier: NCT03340896
Recruitment Status : Recruiting
First Posted : November 14, 2017
Last Update Posted : April 10, 2020
Sponsor:
Information provided by (Responsible Party):
Groupe Oncologie Radiotherapie Tete et Cou

Brief Summary:
This study compare the survival without laryngeal dysfunction 2 years after the end of treatment, obtained by chemotherapy followed by radiotherapy or chemotherapy with cisplatin administrated during radiotherapy.

Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinoma Drug: Docetaxel Drug: Cisplatin Drug: Fluorouracil Radiation: radiotherapy Phase 3

Detailed Description:

In patients with tumors classified as T3 or T4 larynx and hypopharynx, the usually recommended treatment was total laryngectomy.This intervention allows to obtain locoregional disease control in 75% of cases, without laryngectomy

TPF arm followed by radiotherapy was validated in a Phase III (GORTEC 2000-01), it will be the standard treatment.

The RTOG study concluded that chemotherapy administrated during radiotherapy became a standard of laryngeal preservation.

Taking together all these considerations, it is necessary to perform a direct comparison in a randomized trial to further test this hypothesis. Chemotherapy followed by radiotherapy will be the standard arm. It hopes to increase the survival rate from 52% to 65% in the experimental arm.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Trial of Laryngeal Preservation Comparing Induction Chemotherapy With Cisplatin, 5-fluorouracil and Docetaxel (TPF) Followed by Radiotherapy and Concomitant Administration of Radiotherapy With Cisplatin
Actual Study Start Date : June 25, 2015
Estimated Primary Completion Date : September 24, 2026
Estimated Study Completion Date : September 24, 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: TPF followed by radiotherapy

Induction chemotherapy by Docetaxel 75 mg/m² day 1,cisplatin 75 mg/m² day 1 and 5 fluorouracil 750mg/m²(day 1 to day 5) 3 cycles day1, day 22, day 43 followed (for responders or stable disease patients) by radiotherapy

Radiotherapy ;70 gray fractionization: 2Gy/day, 5days/week, for 7 weeks.

Drug: Docetaxel
Docetaxel 75 mg / m² administered on day 1 of each cycle every 3 weeks as an intravenous (IV) infusion of one hour followed by cisplatin 75 mg / m² administered on day 1 hour infusion followed by 5-FU, 750 mg / m² / day administered in continuous infusion from D1 to D5 (or 120 hours)
Other Name: Taxotere

Drug: Cisplatin
Cisplatin: 75 mg/m² for experimental arm and 100mg/m² for comparator arm administered on day 1 of each cycle every 3 weeks as an intravenous (IV) infusion.
Other Name: Cisplatine

Drug: Fluorouracil
5-FU, 750 mg / m² / day administered in continuous infusion from D1 to D5 (or 120 hours)
Other Name: 5 FU

Radiation: radiotherapy
Radiotherapy : 70Gy (2Gy/day) for 7 weeks.
Other Name: radiation therapy

Experimental: Cisplatin and radiotherapy

Drug and radiation • Cisplatin: 100 mg / m² administered IV at J1, J22 and J43 of radiotherapy

. Radiotherapy 70 gray fractionization: 2Gy/day, 5days/week, for 7 weeks.

Drug: Cisplatin
Cisplatin: 75 mg/m² for experimental arm and 100mg/m² for comparator arm administered on day 1 of each cycle every 3 weeks as an intravenous (IV) infusion.
Other Name: Cisplatine

Radiation: radiotherapy
Radiotherapy : 70Gy (2Gy/day) for 7 weeks.
Other Name: radiation therapy




Primary Outcome Measures :
  1. free survival [ Time Frame: 24 months after treatment initiation ]
    Minimum time between randomization and the occurrence of events such as: death, total laryngectomy, tracheotomy.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 60 months ]
    "From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months").

  2. Progression free survival [ Time Frame: 60 months ]
    "From date of randomization until the date of first documented progression assessed up to 60 months").

  3. Larynx Preservation [ Time Frame: 24 months after treatment initiation ]
    From date of randomization up to 24 months evaluated by dynamic deglutition videoscopy

  4. Feasibility of salvage surgery [ Time Frame: 60 months after randomization ]
    Assessing the number of recurrences that could be successfully treated with salvage surgery and description of postoperative



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Squamous cell carcinoma of the larynx or hypopharynx, histologically proven, locally advanced:

    • T2 not accessible to a supra-cricoid partial laryngectomy or not,
    • T3 without massive infiltration by endolarynx transglottic injury,
    • N0 to N2c
    • No distant metastasis
    • No associated cancer or earlier
  • Patients Previously Untreated
  • Age> 18 years and <75 years
  • PS 0 or 1 according to WHO
  • Tumor volume assessable by RECIST.
  • Absence of distant metastasis, confirmed by chest TDM, abdominal ultrasound (or TDM) in case of abnormal liver function and bone scan if local symptoms.
  • Absence of any participation in a clinical trial within 30 days prior to inclusion.
  • Absence of any concomitant cancer treatment.
  • Absence of any chronic treatment ( ≥3 months) with a daily corticosteroid dose is ≥20 mg / day of methylprednisolone or equivalent.
  • Hematological function: neutrophils ≥1.5 x 109 / L, platelets ≥100 x 109 / l, hemoglobin ≥10 g / dl (or 6.2 mmol / l).
  • Hepatic function: normal total bilirubin; AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN (LNS) of each center; alkaline phosphatase ≤ 5 x LNS.
  • Renal function: serum creatinine ≤ 120 mol / l (1.4 mg / dl); if creatinine > 120 mol / l, creatinine clearance should be ≥ 60 ml / min.
  • calculated creatinine clearance (Crockcroft formula) or measured ≥ 60 ml / min
  • Estimated life expectancy ≥ 3 months
  • Weight loss less than 10% over the last 3 months
  • VHI and DHI questionary
  • Quality of Life Questionnaire QLQ-C30 and QLQ-H & N35
  • Patient has given its written consent before any specific procedure of the Protocol.
  • Women and men of childbearing age should have accepted a medically effective contraception during the treatment period and at least 6 months after discontinuation of study treatments (Docetaxel, 5-Fluorouracil and Cisplatin. If pregnancy is declared by a patient or partner of a patient, it must be followed to know the evolution of pregnancy.
  • Dynamic Vidéoscopie of deglutition

Exclusion Criteria:

  • transglottic T3 with massive infiltration of hemilarynx or T4 with massive cartilaginous tumor lysis or reverse cricoarythénoïdenne region or posterior hypopharyngeal wall
  • tumor requiring the completion of an immediately tracheotomy.
  • Tumour available immediately to partial surgery.
  • tumor requiring circular hypopharyngectomie
  • N3 nodal injury
  • Vaccination against yellow fever recent or anticipated
  • Deficit known dihydropyrimidine dehydrogenase (DPD)
  • Other malignancies within 5 years prior to randomization, with the exception of adequately treated basal skin cancer and carcinoma in situ of the cervix.
  • Patients with AST or ALT> 1.5xULN associated with alkaline phosphatase > 2.5x LNS will not be eligible for testing.
  • symptomatic neuropathy grade ≥2 with NCI-CTC.
  • Clinical alteration of hearing function.
  • Other concomitant serious medical conditions (partial list):

    • Unstable cardiac disease despite treatment.
    • Myocardial infarction within 6 months prior to trial entry.
    • Neurological or psychiatric history such as dementia, seizures;
    • Severe uncontrolled infection.
    • Significant gastrointestinal abnormalities, including those that require parenteral nutrition, active peptic ulcer disease and a history of surgical procedures affecting absorption
    • Obstructive pulmonary disease requiring hospitalization in the year before inclusion.
    • Unstable diabetes or other cons-indications to corticosteroids.
    • Significant ophthalmologic abnormality.
    • Moderate or severe eczema.
  • Allergy to iodine.
  • Hypersensitivity to Docetaxel, Cisplatin or at one of their excipients.
  • Concomitant use of phenytoin, carbamazepine, barbiturates and rifampicin.
  • Presence, selection, psychological factors, family, social or geographical may alter patient compliance with the study protocol and follow-up, a criterion of non-inclusion. These factors should be discussed with the patient before inclusion in the trial.
  • Pregnant or nursing women.
  • Patient (male or female) of childbearing age not taking adequate contraceptive measures.

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): NCT03340896


Contacts
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Contact: Gilles CALAIS, Pr + 33 247478265 gilles.calais@univ-tours.fr
Contact: Marie-Hélène GIRARD CALAIS +33 247479121 rc.corad@chu-tours.fr

Locations
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France
Hôpital Bretonneau, Service CORad Pôle Henry S Kaplan Recruiting
Tours, France, 37044
Contact: Gilles CALAIS, Pr    + 33 247478265    gilles.calais@univ-tours.fr   
Contact: Marie-Hélène GIRARD CALAIS    +33 247479121    rc.corad@chu-tours.fr   
Sponsors and Collaborators
Groupe Oncologie Radiotherapie Tete et Cou
Investigators
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Principal Investigator: Gilles CALAIS Hôpital Bretonneau, Service CORad Pôle Henry S Kaplan
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Responsible Party: Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier: NCT03340896    
Other Study ID Numbers: GORTEC 2014-03
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: April 10, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Groupe Oncologie Radiotherapie Tete et Cou:
Larynx, hypopharynx
Additional relevant MeSH terms:
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Squamous Cell Carcinoma of Head and Neck
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Docetaxel
Fluorouracil
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs