- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01391572
A Trial Estimating The Optimal Radiation Volume Of Postsurgical Radiation For Patients With Esophageal Cancer
A Randomized Phase II Trial Estimating The Optimal Radiation Volume Of Postsurgical Radiation For Patients With Locoregionally Advanced Thoracic Esophageal Squamous Cell Carcinoma
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Patient Population:
Thoracic esophageal squamous cell carcinoma after esophagectomy with at least 15 lymph nodes removed for adequate nodal staging.
T3-4, any N, M0.
Scheme:
After esophagectomy, patients are firstly stratified by 2 factors: (1)number of lymph node metastasis (<3 or >=3) and (2)tumor resection status (R1 resection or R2 resection).
Note: Pathological R0 resection status is required for this study. So here R1 and R2 resection are not actually pathological status of resection, only clinical judgement by physician based on the chest-CT before esophagectomy.
Then patients are randomized to 2 arms:
Arm A:
Large field radiation (tumor bed + ENI (elective nodal irradiation)) + Sequential chemotherapy (4 cycles).
Arm B:
Small field radiation (tumor bed only) + Sequential chemotherapy (4 cycles).
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Shanghai
-
Shanghai, Shanghai, Kina, 200032
- Rekruttering
- Fudan University Cancer Center
-
Kontakt:
- Xu-Wei Cai, M.D., Ph.D.
- Telefonnummer: 1504 8621-64175590
- E-mail: birdhome2000@hotmail.com
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Ledende efterforsker:
- Xiao-Long Fu, M.D., Ph.D.
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Age ≥ 18 and ≤70
- Performance status 0-1
- Weight is not less than 90% of it before operation
- Registration within 8 weeks after esophagectomy
- Histologically proven primary thoracic esophageal squamous cell carcinoma
- R0 resection and number of lymph nodes dissected ≥15 after esophagectomy
- Pathological stage of T3-4N0-3M0
- Chest and abdominal contrast enhanced CT within 6 weeks prior to registration(PET/CT scan is selective)
- Without supraclavicular nodes and abdominal regions nodes existed after surgery
- Without neo-adjuvant chemotherapy and radiotherapy
- WBC≥ 4.0X109/L ,Absolute neutrophil count (ANC) ≥ 2.0X109/L
- Platelets ≥ 100X109/L
- Hemoglobin ≥ 90g/L(without blood transfusion)
- AST (SGOT)/ALT (SGPT) ≤ 2.5 x upper limit of normal, Bilirubin ≤ 1.5 x upper limit of normal
- Creatinine ≤ 1.5 x upper limit of normal
- Sign study-specific informed consent prior to study entry
Exclusion Criteria:
- Multiple primary esophageal tumors
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
Severe, active comorbidity, defined as follows:
3.1 Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months 3.2 Transmural myocardial infarction within the last 6 months 3.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration 3.4 Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration 3.5 Acquired immune deficiency syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.
- Prior systemic chemotherapy, prior radiation therapy or prior target drug therapy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: A
After esophagectomy, patients in Arm A will receive Large field radiation (tumor bed + ENI (elective nodal irradiation)) + Sequential chemotherapy
|
In Arm A, postsurgical radiation target volume includes tumor bed and elective nodes area
|
|
Aktiv komparator: B
After esophagectomy, patients in Arm B will receive small field radiation (tumor bed only) + Sequential chemotherapy
|
In Arm B, postsurgical radiation target volume includes tumor bed only
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
|---|---|
|
Survival
|
To evaluate if the survival outcome of postsurgical radiation with a small target volume involved tumor bed only is not worse than a large volume (tumor bed and elective nodes) for patients with locoregionally advanced thoracic esophageal squamous cell carcinoma.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
|---|---|
|
Safety and Tolerability
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To evaluate the incidence rate of adverse events-especially radiation-induced lung toxicity
|
|
Failure pattern
|
To evaluate the rationality of radiation target volumes by analyzing the therapeutic failure patterns especially by comparing the in-field and out-of-field recurrences.
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Xiao-Long Fu, M.D, Ph.D., Fudan University
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer efter sted
- Neoplasmer, kirtel og epitel
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Neoplasmer i hoved og hals
- Esophageale sygdomme
- Neoplasmer, pladecelle
- Esophageale neoplasmer
- Karcinom
- Karcinom, pladecelle
- Esophageal pladecellekarcinom
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Fluorouracil
Andre undersøgelses-id-numre
- 2011ESO_FU_01
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