- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03000816
A Study of SBRT for OligoMetastatic ESCC
A Phase 2 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of OligoMetastatic Esophageal Squamous Cell Carcinoma
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Shanghai
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Shanghai, Shanghai, Kina, 200032
- Fudan Universtiy Shanghai Cancer Center
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Patients with metastatic esophageal squamous cell carcinoma who have received initial treatment for the primary site including surgery or chemoradiotherapy. Primary tumor site without progression at registration. The sites of allowed metastases are: peripheral lung, central lung, medistinal/cervical lymph node, liver, spinal/paraspinal, osseous, and abdominal-pelvic lymph node. All metastases not resected must be amenable to SBRT.
- 1-4 radiographically distinct metastases of any distribution in 2 or less allowed anatomical sites. The diameters of lesions should be less than or equal to 5cm.
- Initial treatment should be completed at least 3 months prior to study registration.
- All the metastases treated with SBRT should not be treated with surgery, radiation, radio frequency ablation or other regional therapeutic modalities prior to study registration. The other (s) lesions should have been surgically removed.
- Age ≥ 18. PS ECOG 0-2,wight loss<30% during the latest 6 months.
- Evaluation by a radiation oncologist that the patient could tolerate the treatment of SBRT.
- Patient must provide study specific informed consent prior to study entry.
- For females of child-bearing potential, negative serum/urine pregnancy test within 14 days prior to study registration.
Exclusion Criteria:
- Progression of primary tumor site at time of registration.
- Metastases with indistinct borders making targeting not feasible.
- Known brain metastases.
- Prior palliative radiotherapy to metastases.
Metastases located within 3 cm of the previously irradiated structures:
a).Spinal cord previously irradiated >80Gy(Biological equivalent dose with α/β=2), b).Brachial plexus previously irradiated to > 100Gy(Biological equivalent dose with α/β=2), c).Small intestine, large intestine, or stomach previously irradiated to > 90Gy (Biological equivalent dose with α/β=2), d).Whole lung previously irradiated with prior V20Gy > 30% (delivered in ≤ 3 Gy/fraction), e)Metastasis irradiated with SBRT.
- Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives.
- Drug addiction,Alcoholism or AIDS.
- Patients with severe organ dysfunction or Acute bacterial or fungal infection who are considered not suitable to enroll the study at the time of registration.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Experimental Arm
Patients in this arm will receive a treatment of SBRT for their oligometastatic lesions.
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Patients with 1-4 metastases located in less than 2 organs/ lymphatic drainage regions that are 5 cm or less from each other and simultaneously treated with SBRT.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Progression-free survival
Tidsram: The survival time from the date each patient enrolled to the date of progression or date of death from any cause, whichever came first, assessed up to 5 years
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progression-free survival will be measured as time to either progression or death
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The survival time from the date each patient enrolled to the date of progression or date of death from any cause, whichever came first, assessed up to 5 years
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Local control
Tidsram: the time from the date each patient enrolled to the date of local failure or the last follow-up, assessed up to 5 years.
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Local control will be measured as time to local recurrence
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the time from the date each patient enrolled to the date of local failure or the last follow-up, assessed up to 5 years.
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overall survival
Tidsram: The survival time from the date each patient enrolled to the date of death or the last follow-up, assessed up to 5 years.
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Overall survival will be measured as time until death from any cause
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The survival time from the date each patient enrolled to the date of death or the last follow-up, assessed up to 5 years.
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Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Kuaile Zhao, MD., Fudan Universtiy Shanghai Cancer Center
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Neoplasmer efter histologisk typ
- Neoplasmer
- Neoplasmer efter plats
- Neoplasmer, körtel och epitel
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Gastrointestinala sjukdomar
- Neoplasmer i huvud och hals
- Esofagussjukdomar
- Neoplasmer, skivepitelceller
- Esofagusneoplasmer
- Carcinom
- Karcinom, skivepitel
- Esofagus skivepitelcancer
Andra studie-ID-nummer
- ESO-Shanghai10
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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