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A Trial Estimating The Optimal Radiation Volume Of Postsurgical Radiation For Patients With Esophageal Cancer

20. juli 2011 opdateret af: Fudan University

A Randomized Phase II Trial Estimating The Optimal Radiation Volume Of Postsurgical Radiation For Patients With Locoregionally Advanced Thoracic Esophageal Squamous Cell Carcinoma

A randomized phase II trial to estimate the optimal radiation volume of postsurgical radiation for patients with locoregionally advanced thoracic esophageal squamous cell carcinoma (T3-4, any N, M0).

Studieoversigt

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

Interventionel

Tilmelding (Forventet)

300

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Shanghai
      • Shanghai, Shanghai, Kina, 200032
        • Rekruttering
        • Fudan University Cancer Center
        • Kontakt:
        • Ledende efterforsker:
          • Xiao-Long Fu, M.D., Ph.D.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Age ≥ 18 and ≤70
  2. Performance status 0-1
  3. Weight is not less than 90% of it before operation
  4. Registration within 8 weeks after esophagectomy
  5. Histologically proven primary thoracic esophageal squamous cell carcinoma
  6. R0 resection and number of lymph nodes dissected ≥15 after esophagectomy
  7. Pathological stage of T3-4N0-3M0
  8. Chest and abdominal contrast enhanced CT within 6 weeks prior to registration(PET/CT scan is selective)
  9. Without supraclavicular nodes and abdominal regions nodes existed after surgery
  10. Without neo-adjuvant chemotherapy and radiotherapy
  11. WBC≥ 4.0X109/L ,Absolute neutrophil count (ANC) ≥ 2.0X109/L
  12. Platelets ≥ 100X109/L
  13. Hemoglobin ≥ 90g/L(without blood transfusion)
  14. AST (SGOT)/ALT (SGPT) ≤ 2.5 x upper limit of normal, Bilirubin ≤ 1.5 x upper limit of normal
  15. Creatinine ≤ 1.5 x upper limit of normal
  16. Sign study-specific informed consent prior to study entry

Exclusion Criteria:

  1. Multiple primary esophageal tumors
  2. 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).
  3. 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.

  4. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.
  5. Prior systemic chemotherapy, prior radiation therapy or prior target drug therapy

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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
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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2011

Primær færdiggørelse (Forventet)

1. december 2013

Datoer for studieregistrering

Først indsendt

8. juli 2011

Først indsendt, der opfyldte QC-kriterier

11. juli 2011

Først opslået (Skøn)

12. juli 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

22. juli 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juli 2011

Sidst verificeret

1. marts 2011

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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