A Randomized PhaseII/III Study of Concurrent Chemoradiotherapy with Low Dose Cisplatin plus 5-FU versus Concurrent Chemoraiotherapy with Standard Dose Cisplatin plus 5-FU for Locally Advanced Unresetable Esophageal Cancer in the Thorax.(JCOG0303)

INTERVENTION: A: Standard Dose concurrent chemoradiotherapy (RT: 60Gy/30fr/6w; Cisplatin 70mg/m2 on day 1,29; 5‐FU 700mg/m2 on days 1‐4, 29‐32) B:Low Dose concurrent chemoradiotherapy (RT: 60Gy/30fr /6w; Cisplatin 4mg/m2 and 5‐FU 200mg/m2, 5 days every week, repeatedly for 6 weeks.) CONDITION: Locally advanced unresectable esophageal cancer in the thorax PRIMARY OUTCOME: overall survival SECONDARY OUTCOME: complete response rate, treatment completion rate, treatment completion rate by PS, adverse events INCLUSION CRITERIA: 1)Esophageal cancer histologically proven by GIF biopsy (squamons cell carcinoma, adenosquamous carcinoma, basaloid carcinoma) 2)Location of the lesion confirmed by esophagogram i)Lesion mainly located in the thoracic esophagus ii)Both primary lesion and intramural matastasis do not invade beyond GE junction 3)Radiotherapist determines before registration that irradiation up to 60 Gy can be completed safely. 4)Tumors are judged unresectable by CT and palpation for the following reason. i)Primary tumor invasion depth T4 ii)Metastatic regional lymph node(s) invasion to adjacent organ. iii)Metastatic lymph node(s) such as fixed supraclavicular or coeliac lymph node(s) provided according to the location of main tumor. 5)No distant organ metastasis. 6)Neither esophago‐airway fistula nor esophago‐mediastinal fistula 7)Neither Radiotherapy nor chemotherapy against any cancers. No previous therapy except EMR against esophageal cancer

Epistemonikos ID: 763484ec772289b9f2a7b7b34e7ee4b7d119f169
First added on: Aug 21, 2024