Radiation Therapy and Chemotherapy, With or Without Cetuximab, Followed by Surgery in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed by Surgery

• Register: ClinicalTrials.gov
• Last refreshed on: 11 March 2013
• Main ID: NCT01107639
• Date of registration: 20/04/2010
• Primary sponsor: Swiss Group for Clinical Cancer Research
• Public title: Radiation Therapy and Chemotherapy, With or Without Cetuximab, Followed by Surgery in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed by Surgery
• Scientific title: Multimodal Therapy With and Without Cetuximab in Patients With Locally Advanced Esophageal Carcinoma - An Open-Label Phase III Trial
• Date of first enrolment: April 2010
• Target sample size: 300
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01107639
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Austria, France, Germany, Hungary, Switzerland

Contacts

• Name: Thomas Ruhstaller, MD

• Name: Thomas Ruhstaller, MD
• Affiliation: Kantonsspital St. Gallen

• Name: Michael Stahl, MD
• Affiliation: Kliniken Essen-Mitte

Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed esophageal carcinoma

- Meets the following criteria:

- Resectable, locally advanced disease as determined by the combination of CT
scan, endoluminal ultrasound (EUS), PET scan, and a multidisciplinary team
discussion

- T2, N1-3; T3, any N; or T4a, any N (if technically resectable with curative
intent [R0] as decided by a multidisciplinary team discussion)

- EUS-guided fine-needle aspiration (FNA) allowed, but determines nodal
status only if positive FNA

- No T1, any N, M0; or T2, N0, M0; T4a (due to infiltration of the
trachea-bronchial tree or organ involvement that cannot be operated on with
curative intent [R0] as decided by a multidisciplinary team discussion);
T4b; or distant metastasis (M1)

- Type I or II disease according to the Siewert classification

- Squamous cell carcinoma (including basaloid-squamous cell and adenosquamous
carcinoma) or adenocarcinoma of the thoracic esophagus or the esophagogastric
junction (from 5 cm below the entrance of the esophagus into the thorax to the
gastric cardia)

- Patients with obstructive tumors are eligible (obstructive tumors will be considered
as locally advanced tumors)

- No cervical esophageal carcinoma and tumors involving the first 5 cm of the thoracic
esophagus

- No airway infiltration in case of tumors at or above the tracheal bifurcation

- No peritoneal carcinomatosis in case of adenocarcinomas infiltrating the gastric
cardia (i.e., esophagogastric junction carcinoma Siewert type I or II)

PATIENT CHARACTERISTICS:

- WHO performance status 0-1

- Neutrophil count = 1.5 x 10^9/L

- Platelet count = 100 x 10^9/L

- Creatinine clearance > 60 mL/min

- Bilirubin = 1.0 times upper limit of normal (ULN)

- Alkaline phosphatase = 2.5 times ULN

- AST = 1.5 times ULN

- INR normal

- PTT = 1.0 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 12 months after
completion of study therapy

- FEV_1 = 1.5 L OR = 75% of the reference value

- Must be compliant and geographically proximal for staging and follow-up

- Considered operable (i.e., appropriate organ functions and ability to undergo general
anesthesia)

- No other malignancies within the past 5 years except nonmelanomatous skin cancer or
adequately treated carcinoma in situ of the cervix

- No severe or uncontrolled cardiovascular disease, including any of the following:

- NYHA class III-IV congestive heart failure

- Unstable angina pectoris

- Myocardial infarction within the past 12 months

- Significant arrhythmias

- No psychiatric disorder precluding understanding of information on trial related
topics, giving informed consent, and answering questionnaires

- No active uncontrolled infection

- No serious underlying medical condition that, in the opinion of the investigator,
could impair the ability of the patient to participate in the trial (e.g.,
uncontrolled diabetes mellitus or active autoimmune disease)

- No preexisting peripheral neuropathy > grade 1

- No definite contraindications for the use of corticosteroids and antihistamines as
premedication

- No known hypersensitivity to trial drugs or hypersensitivity to any other component
of the trial drugs

PRIOR CONCURRENT THERAPY:

- No prior chemotherapy or radiotherapy to the chest

- At least 30 days since prior treatment in another clinical trial

- No concurrent drugs contraindicated for use with the trial drugs

- No other concurrent anticancer treatments

- No other concurrent experimental drugs or investigational treatments



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Adenocarcinoma of the Gastroesophageal Junction

Esophageal Cancer

Intervention(s)

Biological: cetuximab

Drug: cisplatin

Drug: docetaxel

Procedure: adjuvant therapy

Procedure: neoadjuvant therapy

Primary Outcome(s)

Progression-free survival (PFS) [Time Frame: time from randomization to a defined event.]

Secondary Outcome(s)

Adverse events according to CTCAE version 4.0 and major postoperative complications [Time Frame: during treatment and follow-up period.]

In-hospital mortality [Time Frame: occurring after surgery but while the patient remains in hospital]

Overall survival [Time Frame: time from trial randomization to the date of death from any cause]

Pathological remission [Time Frame: Assessed according to the tumor regression model of Mandard]

Progression-free survival after surgery [Time Frame: from date of surgery to an event as defined in PFS.]

Time to locoregional failure after R0 resection [Time Frame: from date of surgery to date of first documented loco-regional failure]

Time to progression (TTP) [Time Frame: Time to progression is defined as time from randomization to one of the following events, whichever comes first: - Tumor progression at any time. - Recurrence at local, regional or distant site after surgery. - Death due to tumor]

Time to systemic failure after R0 resection [Time Frame: from date of surgery to date of first documented systemic failure]

Secondary ID(s)

CDR0000669249

EU-21024

EUDRACT-2009-016584-10

SAKK 75/08

SWS-SAKK-75/08

Source(s) of Monetary Support

Please refer to primary and secondary sponsors