Chemoradiotherapy Followed by Planned Surgery or by Surveillance and Surgery Only When Needed for Oesophageal Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

1,020

Participants

Timeline

Start Date

November 27, 2020

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2031

Conditions
Esophageal Squamous Cell Carcinoma
Interventions
RADIATION

Neoadjuvant radiotherapy (arm A)

1.8 Gy fractions 5 days per week in 23 fractions to a total dose of 41.4 Gy.

DRUG

Carboplatin, paclitaxel

Carboplatin AUC 2 + Paclitaxel 50mg/m2 weekly x 5 (day 1, 8, 15, 22, 29), starting same day as radiotherapy

PROCEDURE

Esophagectomy

Esophagectomy performed within 8 weeks after termination of chemoradiotherapy

RADIATION

Neoadjuvant radiotherapy (arm B)

"Two alternative schemes:~1. 1.8 Gy fractions five days per week in 28 fractions to a total dose of 50.4 Gy.~2. 2.0 Gy fractions five days per week in 25 fractions to a total dose of 50 Gy."

DRUG

Carboplatin, paclitaxel

Carboplatin AUC 2 + Paclitaxel 50mg/m2 on day 1 weekly during the full course of radiotherapy (5 weeks or 6 weeks, depending on the radiotherapy regimen used).

DRUG

Cisplatin, paclitaxel

Cisplatin 75mg/m2 on the first day of weeks 1 and 5 + 5-fluorouracil 1000 mg/m2/day by continuous infusion on the first four days of weeks 1 and 5.

DRUG

Oxaliplatin, calcium folinate, 5-fluorouracil

FOLFOX: Oxaliplatin 85 mg/m2, calcium folinate 200 mg/m2 and 5-fluorouracil 400 mg/m2 on the first days of weeks 1, 3 and 5 + 5-fluorouracil 800 mg/m2 by continuous infusion on the first two days of weeks 1, 3 and 5.

PROCEDURE

Esophagectomy

Esophagectomy only in case of residual or recurrent locoregional cancer.

Trial Locations (12)

Unknown

RECRUITING

McGill University Health Centre, Montreal

RECRUITING

Oslo universitetssykehus, Oslo

RECRUITING

Universitetssykehuset Nord-Norge, Tromsø

RECRUITING

St Olavs Hospital, Trondheim

RECRUITING

Linköpings universitetssjukhus, Linköping

RECRUITING

Skånes universitetssjukhus, Lund

RECRUITING

Örebro universitetssjukhus, Örebro

RECRUITING

Karolinska University Hospital, Stockholm

RECRUITING

Norrlands universitetssjukhus, Umeå

RECRUITING

Akademiska sjukhuset, Uppsala

RECRUITING

Chang Gung Memorial Hospital, Linkou District

D08 NHY1

RECRUITING

Cancer Clinical Trials Unit (CCTU) at St. James's Hospital, Dublin

All Listed Sponsors
collaborator

University of Leipzig

OTHER

collaborator

The Swedish Research Council

OTHER_GOV

lead

Karolinska University Hospital

OTHER