CROSS II.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20325

Enrollment

350

Registered

2005-09-16

Start date

2004-03-18

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Esophageal cancer.

Interventions

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 r

Eligibility

Inclusion criteria

Inclusion criteria: 18 < age < 75 year, surgical resectable T2-3, N0-1, M0, tumour length longitudinal <8cm and radial <5cm, no invasion tracheobronchial tree, tumour must not extend more than 2 cm into the stomach, ECOG 0-2.

Exclusion criteria

Exclusion criteria: T1N1, T1N0, past or current history of malignancy other than entry diagnosis, previouw chemotherapy or radiotherapy, MI in last 6 months, congestive heart failure or arrhythmia requiring medication, neurotoxicity grade >1, inadequate caloric and or fluid intake, weight loss 10%.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1. To compare pathological responses; 2. Progression free survival; 3. Number of R0 resections; 4. Treatment toxicity; 5. Costs.	—

Contacts

Public ContactA. Gaast, van der

Erasmus Medical Center, Department of Medical Oncology, P.O. Box 2040,

a.vandergaast@erasmusmc.nl+31 (0)10 4634897

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)