- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03731442
Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients
Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients: A Prospective, Multicenter Clinical Trial
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Currently, adjuvant therapy is not recommended for patients with esophageal squamous cell carcinoma who received surgery as their first treatment. However, the recurrence rate is as high as 23.8%-58%, and the median time-to-recurrence is about 10.5 months. In patients who had residual tumor after surgery, evidence lacks for chemoradiation.
Retrospective data of 218 cases in our hospital indicated patients underwent salvage chemoradiation had significantly improved survival compared with chemotherapy, radiotherapy or best supportive care. For patients with locoregional recurrence, the 1-, 3-year overall survival (OS) rates were statistically higher in patients received salvage chemoradiation than radiotherapy (1-year OS, 70.0% vs. 55.2%, 3-year OS, 41.9% vs. 23.5%, p=0.045). Patients received chemotherapy had 1-year OS of 0%.
Data of 218 cases of our hospital indicated patients received radiation dose > 54Gy had a significantly longer median overall survival time of 21.2 months compared with 11.3 months in patients had <54Gy. The optimal radiation dose should be further investigated.
The recurrence pattern of patients with esophageal cancer after esophagectomy mainly consist of supraclavicular and mediastinal lymph nodes. For patients recurred after radical surgery, prophylactic irradiation to high-risk lymph node regions should be considered. The study use simultaneously integrated boost (SIB) intensity-modulated radiation therapy (IMRT) in this trial, which made different radiation dose to recurrent tumor and high-risk lymph node regions possible.
The aim of the study is to evaluate the efficacy and safety of chemoradiation therapy in patients with recurrences after radical surgery or palliative surgery. Patients were further assigned to receive elective field irradiation (ENI) or involved field irradiation (IFI) according to tumor size, tumor location and time-to-recurrence.
Studietype
Registrering (Forventet)
Fase
- Fase 3
Kontakter og plasseringer
Studiekontakt
- Navn: Lei Deng, MD
- Telefonnummer: +86-18611766429
- E-post: dengleipumc@163.com
Studiesteder
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Beijing
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Beijing, Beijing, Kina, 100021
- Rekruttering
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
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Ta kontakt med:
- Zefen Xiao, MD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Locoregional recurrence after radical surgery;
- Positive resection margin (R1/R2) after surgery;
- Out-of-field recurrence after adjuvant chemoradiation or radiotherapy;
- Recurrence after adjuvant chemotherapy;
- No prior therapy after recurrence;
- Age 16-70 years;
- KPS>70;
- No history of drug allergy;
- Sufficient liver and kidney functions;
- White blood cell count > 4.0*10^9/L.
Exclusion Criteria:
- Age>70 or <16 years;
- Pregnancy or lactation;
- History of drug allergy;
- Declining informed consent;
- Insufficient liver or kidney functions, or abnormal CBC test;
- Severe cardiovascular diseases, infections, active ulcerations, diabetes mellitus with unstable blood sugar, mental disorders.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Involved field irradiation
Patients after R0 surgery whose recurrence lesion larger than 5cm in diameter, or largest diameter was less than 5cm but with skip metastasis far from primary tumor or their time-to-recurrence longer than 16 months were assigned to involved field irradiation group.
For lesions far from the thoracic stomach, the prescribed dose is 60Gy/2Gy/30f, and for lesions close to the thoracic stomach, the prescribed dose is 59.4-61.2Gy/1.8Gy/33-34f.
Chest CT scan is planned at 50Gy.
Radiation field should be modified according to the tumor response.
Concurrent chemotherapy of paclitaxel and platinum was delivered every 3 weeks.
PEG-rhG-CSF (3-6mg) should be given after 48 hours of chemotherapy.If patients received postoperative chemotherapy of paclitaxel and platinum and went through local-regional recurrence within six months, it is allowed to deliver chemotherapy regimens in the second line.
Consolidate chemotherapy were adjusted to the patients after radiation therapy.
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Involved field irradiation; intensity-modulated radiation therapy
Paclitaxel 135-150mg/m2, d1, every 3 weeks
for lobaplatin, 30mg/m2, d1-2, total dose should not exceed 50mg,every 3 weeks; for nedaplatin 50mg/m2, d1-2, every 3 weeks;
PEG-rhG-CSF 3-6mg, 48 hours after chemotherapy
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Eksperimentell: Elective field irradiation
Patients after R1/R2 surgery or R0 surgery with the recurrence lesion whose diameter was less than 5cm without skip metastasis far from primary tumor and time-to-recurrence shorter than 16 months were assigned to elective field irradiation group.
For lesions far from the thoracic stomach, the prescribed dose is 50.4Gy/1.8Gy/28f
with a simultaneously integrated boost up to 59.92-62.16Gy/2.14-2.22Gy/28f.
For lesions close to the thoracic stomach, the prescribed dose is 50.4Gy/1.8Gy/28f
with a sequential boost of 10-12Gy/1.8-2Gy/5-7f.
For patients whose planned thoracic stomach V50>50%, the dose should be lowered to 45Gy/1.8Gy/25f.
Concurrent chemotherapy of paclitaxel and platinum was delivered every 3 weeks.
PEG-rhG-CSF should be given in need.
If patients received postoperative chemotherapy of TP and went through local-regional recurrence within 6 months, chemotherapy regimens delivered in the second line.
Consolidate chemotherapy were adjusted to the patients after radiation therapy.
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Paclitaxel 135-150mg/m2, d1, every 3 weeks
for lobaplatin, 30mg/m2, d1-2, total dose should not exceed 50mg,every 3 weeks; for nedaplatin 50mg/m2, d1-2, every 3 weeks;
PEG-rhG-CSF 3-6mg, 48 hours after chemotherapy
Elective field irradiation; intensity-modulated radiation therapy
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
1-, 2-, 3-års total overlevelse
Tidsramme: Fra behandlingsstart til død uansett årsak eller sensur, vurdert opp til 36 måneder
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Total overlevelse
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Fra behandlingsstart til død uansett årsak eller sensur, vurdert opp til 36 måneder
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
1-, 2-, 3-års progresjonsfri overlevelse
Tidsramme: Fra behandlingsstart til første dokumenterte progresjon eller død eller sensur, vurdert opp til 36 måneder
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Progresjonsfri overlevelse
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Fra behandlingsstart til første dokumenterte progresjon eller død eller sensur, vurdert opp til 36 måneder
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1-, 2-, 3-year local progression-free survival
Tidsramme: From treatment initiation to first documented local progression or death or censor, assessed up to 36 months
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Local progression-free survival
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From treatment initiation to first documented local progression or death or censor, assessed up to 36 months
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Simultaneously integrated boost radiation therapy completion rate
Tidsramme: During chemoradation, assessed up to 60 days
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Radiation therapy completion rate
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During chemoradation, assessed up to 60 days
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Toxicities according to RTOG and CTCAE criteria, including hematological and non-hematological toxicities
Tidsramme: Assessed within 3 months from initiation of chemoradiaiton (acute), and 3 months after initiation of chemoradiation (late), according to RTOG and CTCAE criteria, including hematological and non-hematological toxicities
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Toxicities of chemoradiation therapy
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Assessed within 3 months from initiation of chemoradiaiton (acute), and 3 months after initiation of chemoradiation (late), according to RTOG and CTCAE criteria, including hematological and non-hematological toxicities
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Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Patologiske prosesser
- Neoplasmer
- Neoplasmer etter nettsted
- Sykdomsattributter
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Neoplasmer i hode og nakke
- Esophageal sykdommer
- Tilbakefall
- Neoplasmer i spiserøret
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitosemodulatorer
- Antineoplastiske midler, fytogene
- Paklitaksel
Andre studie-ID-numre
- 18-175/1753
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