Stereotactic Radiotherapy Combined With Chemotherapy or Not for Treatment of Oligometastases in HNSCC (OMET)
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|ClinicalTrials.gov Identifier: NCT03070366|
Recruitment Status : Recruiting
First Posted : March 3, 2017
Last Update Posted : April 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Squamous Cell Carcinoma||Drug: Chemotherapy Radiation: Stereotactic radiotherapy||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||September 21, 2015|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||December 2020|
Active Comparator: Chemotherapy combined with stereotactic radiotherapy (RT)
Chemotherapy is based on patient Performance Status (PS) and comorbidities:
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.
Radiation: Stereotactic radiotherapy
Experimental: stereotactic radiotherapy
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
- Overall Survival without quality of life deterioration [ Time Frame: 1 year ]Overall Survival rate without definitive deterioration of quality of life (by QLQC30) measured at 1 year post treatment
- Overall Survival [ Time Frame: 1 year ]
- Progression free survival [ Time Frame: 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 [ Time Frame: up to 6 months ]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 [ Time Frame: through study completion, an average of 1 year ]
- Overall response rate [ Time Frame: through study completion, an average of 1 year ]
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): NCT03070366
|Contact: Juliette THARIAT, Pr||(0)6 45 53 98 01 ext +firstname.lastname@example.org|
|Contact: Xu Shan SUN, MD||(0)3 81 98 88 68 ext +email@example.com|
|Hôpital Nord Franche Comté||Recruiting|
|Montbéliard, France, 25209|
|Contact: Xu Shan SUN, MD (0)3 81 98 88 68 ext +33 firstname.lastname@example.org|