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Stereotactic Radiotherapy Combined With Chemotherapy or Not for Treatment of Oligometastases in HNSCC (OMET)

Primary Purpose

Head and Neck Squamous Cell Carcinoma

Status
Active
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Chemotherapy
Stereotactic radiotherapy
Sponsored by
Groupe Oncologie Radiotherapie Tete et Cou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Squamous Cell Carcinoma focused on measuring Oligometastasis, stereotactic irradiation

Eligibility Criteria

18 Years - 77 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years
  • PS:0-2
  • Estimated life expectancy ≥ 6 months
  • Histologically confirmed diagnosis of squamous cell carcinoma of the head and neck
  • Target metastases can be treated in stereotactic radiotherapy
  • 1-3 synchronized metastases with unrestricted anatomic site
  • Greater cumulative diameter of synchronous metastases in once organ (liver, lung or brain) ≤ 6 cm with GTV = Clinical Target Volume (CTV)
  • Global maximum diameter (GTV) allowed for pulmonary oligometastases (less than 2 cm from the mediastinum), brain, node, is ≤ 3cm
  • Implementation of a method for taking into account movements and uncertainties (IGRT) for limiting the margin of CTV to PTV (PTV) so as not to exceed 7 cm large cumulative diameter of PTV
  • Performing a positron emission tomography with 18F-2-fluoro-2-deoxy-D-glucose (FDG-PET) 4 weeks before the inclusion
  • In case of cerebral metastases, MRI diagnostic is required
  • If locoregional disease is treated, controlled and non-progressive for more than three months (+/- 4 weeks) at baseline, synchronized initial tumor is possible
  • If metachronous metastases, locoregional disease previously treated should be monitored and considered not progressive for more than three months at baseline
  • In case of prior cancer other than HNSCC, complete remission for over 5 years is possible, any biopsy of metastases is left to the appreciation of referring physician
  • No chemotherapy or local treatment of metastases in the previous 6 months
  • Laboratory tests consistent with the achievement of chemotherapy: Leukocytes> 3,000 / mm3 (including polynuclear> 2000 / mm3) platelets> 150,000 / mm3, serum glutamate oxaloacetate transminase (SGOT), serum glutamate pyruvate transaminase (SGPT), alkaline phosphatase, bilirubin <2.5 upper limit of normal (ULN)
  • Affiliation to an health insurance
  • Informed Consent Form signed

Exclusion Criteria:

  • Concomitant participation in other interventional clinical trial within 4 weeks before inclusion
  • Other prior ablative treatment of targets metastases (surgery, radio frequency) in the previous six months
  • metachronous primitive tumor (second cancer) uncontrolled.
  • contraindication to any systemic therapy (chemotherapy and / or targeted therapy)
  • Known hypersensitivity reaction to 5FU, cisplatin, carboplatin, platin or cetuximab
  • Active infection (infection requiring IV antibiotics), including active tuberculosis and known and declared human immunodeficiency virus (HIV)
  • Other malignancies within 5 years prior to randomization, with the exception of adequately treated basal skin cancer and carcinoma in situ of the cervix
  • Individual deprived of liberty by judicial or administrative decision, or under any kind of guardianship
  • Pregnant or breast feeding women. Every woman who has childbearing potential, must have a negative pregnancy test (serum or urine) within 14 days previous treatment. Patients (men or women) must use a reliable method of contraception throughout treatment and for at least 6 months after discontinuation of chemotherapy.

Sites / Locations

  • Hôpital Nord Franche Comté

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Chemotherapy combined with stereotactic radiotherapy (RT)

stereotactic radiotherapy

Arm Description

Chemotherapy is based on patient Performance Status (PS) and comorbidities: PS 0-1: standard treatment: 6 cycles, every 3 weeks cisplatin (100 mg/m² iv on D1), 5FU (4000 mg/m² total dose starting on Day 1 to Day 4 and during 96h in continuous infusion) PS 2/cardiac contra-indication to 5 Fluorouracil (5FU): 6 cycles, every 3-4 weeks cisplatin (100 mg/m² iv on Day 1) or carboplatin Area Under Curve (AUC) 4 or 5 on Day 1 In both case: Cetuximab (loading dose 400 mg/m² iv on Day1, then 250 mg/m² weekly or 500mg/m² every 2 weeks). Cycle 1 of systemic treatment will be administered before the start of the stereotactic RT. Then, following cycles will be performed after the end of stereotactic irradiation. Cetuximab maintenance: 250 mg/m² iv weekly. It will be given only if at least disease stabilization is observed at the end of chemotherapy, and will be continued until progression or unacceptable toxicity.

Splitting will be based on the tumor diameter, and proximity of organs at risk which constitutes any limiting toxicities. It will be 3 or 5 fractions based on the recommendations (CARO-Stereotactic Body Radiation Therapy (SBRT) 2012) and for the purpose of harmonization practices. The prescription dose is 3 x 10 = 30 Gy 3 x 11 = 33 Gy or 3 x 15 = 45 Gy (if 3 fractions) with the possibility of 3 x 20 Gy to the peripheral lung nodules with tracking in Cyberknife or 5 x 7 = 35 Gy or 5 Gy x 10 = 50 (if 5 fractions). Beyond 3 cm of tumor diameter and / or to a distance of less than 1 cm from the GTV in an organ critical risk (eg spinal cord), a splitting up into 5 sessions must be privileged.

Outcomes

Primary Outcome Measures

Overall Survival without quality of life deterioration
Overall Survival rate without definitive deterioration of quality of life (by QLQC30) measured at 1 year post treatment

Secondary Outcome Measures

Overall Survival
Progression free survival
Number of participants with adverse events grade 3 as assessed by CTCAE v4.0 within the first 6 months of treatment
Toxicity of grade > or equal to 3, occurring within the first 6 months of treatment
Number of participants with treatment related adverse events as assessed by CTCAE v4.0
Overall response rate

Full Information

First Posted
January 16, 2017
Last Updated
June 19, 2023
Sponsor
Groupe Oncologie Radiotherapie Tete et Cou
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1. Study Identification

Unique Protocol Identification Number
NCT03070366
Brief Title
Stereotactic Radiotherapy Combined With Chemotherapy or Not for Treatment of Oligometastases in HNSCC
Acronym
OMET
Official Title
Randomized Phase II Trial Comparing Chemotherapy Combined With Stereotactic Radiotherapy and Stereotactic Radiotherapy Alone, for Treatment of Oligometastases in Squamous Cell Cancers of the Upper Aerodigestive Tract
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 21, 2015 (Actual)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe Oncologie Radiotherapie Tete et Cou

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to evaluate the rate of living patients at 1 year with a quality of life criteria (no decrease) and reduced toxicities. This criteria will be compared in both groups., A cost effectiveness study is scheduled also.
Detailed Description
Patients with cancers of aerodigestive tract have metastases limited in their evolution and a pauci-metastatic disease. In these cases, systemic therapy is the standard attitude. However, patients often received chemotherapy in their history and response rates are relatively low. The median survival is between 7 and 11 months with secondary effects and degradation of quality of life. It is a palliative treatment. Data on systemic treatment in the context of a micro-metastatic disease are limited. In contrast, stereotactic irradiation in pauci-metastatic context leads to better local control rates and may sustainedly reduce the progression of metastatic disease. Stereotactic radiotherapy is increasing use in clinical practice for limited metastatic stages (oligo metastatic with 1-3 synchronized metastases). Radiotherapy in this indication has major advantages and a similar efficacy compared with other ablative treatments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Carcinoma
Keywords
Oligometastasis, stereotactic irradiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chemotherapy combined with stereotactic radiotherapy (RT)
Arm Type
Active Comparator
Arm Description
Chemotherapy is based on patient Performance Status (PS) and comorbidities: PS 0-1: standard treatment: 6 cycles, every 3 weeks cisplatin (100 mg/m² iv on D1), 5FU (4000 mg/m² total dose starting on Day 1 to Day 4 and during 96h in continuous infusion) PS 2/cardiac contra-indication to 5 Fluorouracil (5FU): 6 cycles, every 3-4 weeks cisplatin (100 mg/m² iv on Day 1) or carboplatin Area Under Curve (AUC) 4 or 5 on Day 1 In both case: Cetuximab (loading dose 400 mg/m² iv on Day1, then 250 mg/m² weekly or 500mg/m² every 2 weeks). Cycle 1 of systemic treatment will be administered before the start of the stereotactic RT. Then, following cycles will be performed after the end of stereotactic irradiation. Cetuximab maintenance: 250 mg/m² iv weekly. It will be given only if at least disease stabilization is observed at the end of chemotherapy, and will be continued until progression or unacceptable toxicity.
Arm Title
stereotactic radiotherapy
Arm Type
Experimental
Arm Description
Splitting will be based on the tumor diameter, and proximity of organs at risk which constitutes any limiting toxicities. It will be 3 or 5 fractions based on the recommendations (CARO-Stereotactic Body Radiation Therapy (SBRT) 2012) and for the purpose of harmonization practices. The prescription dose is 3 x 10 = 30 Gy 3 x 11 = 33 Gy or 3 x 15 = 45 Gy (if 3 fractions) with the possibility of 3 x 20 Gy to the peripheral lung nodules with tracking in Cyberknife or 5 x 7 = 35 Gy or 5 Gy x 10 = 50 (if 5 fractions). Beyond 3 cm of tumor diameter and / or to a distance of less than 1 cm from the GTV in an organ critical risk (eg spinal cord), a splitting up into 5 sessions must be privileged.
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
cisplatin 5FU carboplatin cetuximab
Intervention Type
Radiation
Intervention Name(s)
Stereotactic radiotherapy
Intervention Description
Stereotactic radiotherapy
Primary Outcome Measure Information:
Title
Overall Survival without quality of life deterioration
Description
Overall Survival rate without definitive deterioration of quality of life (by QLQC30) measured at 1 year post treatment
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
1 year
Title
Progression free survival
Time Frame
through study completion, an average of 1 year
Title
Number of participants with adverse events grade 3 as assessed by CTCAE v4.0 within the first 6 months of treatment
Description
Toxicity of grade > or equal to 3, occurring within the first 6 months of treatment
Time Frame
up to 6 months
Title
Number of participants with treatment related adverse events as assessed by CTCAE v4.0
Time Frame
through study completion, an average of 1 year
Title
Overall response rate
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
77 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years PS:0-2 Estimated life expectancy ≥ 6 months Histologically confirmed diagnosis of squamous cell carcinoma of the head and neck Target metastases can be treated in stereotactic radiotherapy 1-3 synchronized metastases with unrestricted anatomic site Greater cumulative diameter of synchronous metastases in once organ (liver, lung or brain) ≤ 6 cm with GTV = Clinical Target Volume (CTV) Global maximum diameter (GTV) allowed for pulmonary oligometastases (less than 2 cm from the mediastinum), brain, node, is ≤ 3cm Implementation of a method for taking into account movements and uncertainties (IGRT) for limiting the margin of CTV to PTV (PTV) so as not to exceed 7 cm large cumulative diameter of PTV Performing a positron emission tomography with 18F-2-fluoro-2-deoxy-D-glucose (FDG-PET) 4 weeks before the inclusion In case of cerebral metastases, MRI diagnostic is required If locoregional disease is treated, controlled and non-progressive for more than three months (+/- 4 weeks) at baseline, synchronized initial tumor is possible If metachronous metastases, locoregional disease previously treated should be monitored and considered not progressive for more than three months at baseline In case of prior cancer other than HNSCC, complete remission for over 5 years is possible, any biopsy of metastases is left to the appreciation of referring physician No chemotherapy or local treatment of metastases in the previous 6 months Laboratory tests consistent with the achievement of chemotherapy: Leukocytes> 3,000 / mm3 (including polynuclear> 2000 / mm3) platelets> 150,000 / mm3, serum glutamate oxaloacetate transminase (SGOT), serum glutamate pyruvate transaminase (SGPT), alkaline phosphatase, bilirubin <2.5 upper limit of normal (ULN) Affiliation to an health insurance Informed Consent Form signed Exclusion Criteria: Concomitant participation in other interventional clinical trial within 4 weeks before inclusion Other prior ablative treatment of targets metastases (surgery, radio frequency) in the previous six months metachronous primitive tumor (second cancer) uncontrolled. contraindication to any systemic therapy (chemotherapy and / or targeted therapy) Known hypersensitivity reaction to 5FU, cisplatin, carboplatin, platin or cetuximab Active infection (infection requiring IV antibiotics), including active tuberculosis and known and declared human immunodeficiency virus (HIV) Other malignancies within 5 years prior to randomization, with the exception of adequately treated basal skin cancer and carcinoma in situ of the cervix Individual deprived of liberty by judicial or administrative decision, or under any kind of guardianship Pregnant or breast feeding women. Every woman who has childbearing potential, must have a negative pregnancy test (serum or urine) within 14 days previous treatment. Patients (men or women) must use a reliable method of contraception throughout treatment and for at least 6 months after discontinuation of chemotherapy.
Facility Information:
Facility Name
Hôpital Nord Franche Comté
City
Montbéliard
ZIP/Postal Code
25209
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The Data Monitoring Committee will meet every year either by a physical meeting or by conference call. Data on the recruitment, toxicity and autonomy are submitted every year.

Learn more about this trial

Stereotactic Radiotherapy Combined With Chemotherapy or Not for Treatment of Oligometastases in HNSCC

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