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- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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).
Type d'étude
Inscription (Anticipé)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
-
Shanghai
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Shanghai, Shanghai, Chine, 200032
- Recrutement
- Fudan University Cancer Center
-
Contact:
- Xu-Wei Cai, M.D., Ph.D.
- Numéro de téléphone: 1504 8621-64175590
- E-mail: birdhome2000@hotmail.com
-
Chercheur principal:
- Xiao-Long Fu, M.D., Ph.D.
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
|
|
Comparateur actif: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
|---|---|
|
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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
|---|---|
|
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.
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Xiao-Long Fu, M.D, Ph.D., Fudan University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système digestif
- Tumeurs par type histologique
- Tumeurs
- Tumeurs par site
- Tumeurs, glandulaires et épithéliales
- Tumeurs gastro-intestinales
- Tumeurs du système digestif
- Maladies gastro-intestinales
- Tumeurs de la tête et du cou
- Maladies de l'oesophage
- Tumeurs à cellules squameuses
- Tumeurs de l'oesophage
- Carcinome
- Carcinome épidermoïde
- Carcinome épidermoïde de l'œsophage
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Antimétabolites, Antinéoplasique
- Antimétabolites
- Agents antinéoplasiques
- Agents immunosuppresseurs
- Facteurs immunologiques
- Fluorouracile
Autres numéros d'identification d'étude
- 2011ESO_FU_01
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