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

NCT03070366 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: GORTEC 2014-04
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Oligometastasis; stereotactic irradiation

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Secondary Outcomes (5)

• Overall Survival

  1 year

• Progression free survival

  through study completion, an average of 1 year

• Number of participants with adverse events grade 3 as assessed by CTCAE v4.0 within the first 6 months of treatment

  up to 6 months

• Number of participants with treatment related adverse events as assessed by CTCAE v4.0

  through study completion, an average of 1 year

• Overall response rate

  through study completion, an average of 1 year

Study Arms (2)

Chemotherapy combined with stereotactic radiotherapy (RT)

ACTIVE COMPARATOR

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.

Drug: Chemotherapy; Radiation: Stereotactic radiotherapy

stereotactic radiotherapy

EXPERIMENTAL

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.

Radiation: Stereotactic radiotherapy

Interventions

Chemotherapy DRUG

* cisplatin * 5FU * carboplatin * cetuximab

Chemotherapy combined with stereotactic radiotherapy (RT)

Stereotactic radiotherapy RADIATION

Stereotactic radiotherapy

Chemotherapy combined with stereotactic radiotherapy (RT); stereotactic radiotherapy

Eligibility Criteria

• Age: 18 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Groupe Oncologie Radiotherapie Tete et Cou: lead

Study Sites (1)

Hôpital Nord Franche Comté

Montbéliard, 25209, France

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Drug Therapy; Radiosurgery

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Therapeutics; Radiotherapy; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2017
• First Posted: March 3, 2017
• Study Start: September 21, 2015
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)