Neoadjuvant chemoradiation followed by surgery versus surgery alone for patients with adenocarcinomas or squamous cell carcinomas of the esophagus

ISRCTN	ISRCTN80832026
DOI	https://doi.org/10.1186/ISRCTN80832026
Secondary identifying numbers	NTR487; EMC 03-209 (CKTO 2004-13)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr A. Gaast, van der
Scientific

Erasmus Medical Center
Department of Medical Oncology
P.O. Box 5201
Rotterdam
3008 AE
Netherlands

Study design	Multicentre randomised active controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	CROSS II
Study objectives	Surgery is the standard therapy for esophageal cancer. However, 30% of the resections are irradical. It is thought that preceding chemoradiotherapy will improve the surgery results.
Ethics approval(s)	Received from the local medical ethics committee
Health condition(s) or problem(s) studied	Esophageal cancer
Intervention	Paclitaxel 50 mg/m2 and carboplatin AUC = 2 on days 2, 8, 15, 22 and 29. Radiotherapy will start on day 1 of chemotherapy. A total of 41.4 Gy, 23 fractions of 1.8 Gy, 5 fractions a week. Surgery (if randomised in this arm) will preferably be performed within 6 weeks after completion of chemoradiation.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Paclitaxel, carboplatin
Primary outcome measure	1. To compare median survival rates between patients treated for surgical resectable esophageal adenocarcinoma or squamous cell carcinoma 2. To compare quality of life before, during and after treatment
Secondary outcome measures	1. To compare pathological responses 2. Progression free survival 3. Number of R0 resections 4. Treatment toxicity 5. Costs
Overall study start date	18/03/2004
Completion date	01/01/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	350
Key inclusion criteria	1. Age >18, <75 years 2. Surgical resectable T2-3, N0-1, M0 3. Tumour length longitudinal <8 cm and radial <5 cm 4. No invasion tracheobronchial tree 5. Tumour must not extend more than 2 cm into the stomach 6. ECOG 0-2
Key exclusion criteria	1. T1N1 2. T1N0 3. Past or current history of malignancy other than entry diagnosis 4. Previous chemotherapy or radiotherapy 5. MI in last 6 months 6. Congestive heart failure or arrhythmia requiring medication 7. Neurotoxicity grade >1 8. Inadequate caloric and or fluid intake 9. Weight loss 10%
Date of first enrolment	18/03/2004
Date of final enrolment	01/01/2006

Erasmus Medical Center

Rotterdam
3008 AE
Netherlands

Erasmus Medical Center, Department of Medical Oncology (Netherlands)
Not defined

P.O. Box 5201
Rotterdam
3008 AE
Netherlands

"ROR"	https://ror.org/018906e22

Charity

Dutch Cancer Society (Netherlands)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	result	01/06/1991		Yes	No