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)

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) - 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)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000861

Enrollment

364

Registered

2007-10-23

Start date

2004-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced unresectable esophageal cancer in the thorax

Interventions

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.)

Eligibility

Sex/Gender

All

Inclusion criteria

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 8)Age from 20 to 75 years 9)Performance status of 0-2 10)Adequate organ function 11)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Simultaneous or metachronous (within 5 years) double cancers 2)Pregnancy or lactation 3)Serious psychiatric illness 4)Steroid treatment 5)HBs antigen positive 6)Uncontrollable diabetes 7)Myocaedial infarcion within 3 months 8)Serious comorbidity 9)Active bacterial or fungous infection

Design outcomes

Primary

Measure	Time frame
overall survival	—

Secondary

Measure	Time frame
complete response rate, treatment completion rate, treatment completion rate by PS, adverse events	—

Countries

Japan

Contacts

Public ContactMasayuki Shinoda

JCOG0303 Coordinating Office Department of Thoracic Surgery, Aichi Cancer Center Hospital

JCOG_sir@ml.jcog.jp052-762-6111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026