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

• Status: Completed
• Trial end date: 2018-12-09
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Radiation therapy uses high-energy x-rays and to kill tumor cells. Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving radiation therapy together with chemotherapy is more effective with or without cetuximab in treating patients with esophageal cancer.

PURPOSE: This randomized phase III trial is studying giving radiation therapy together with chemotherapy, with or without cetuximab, followed by surgery in treating patients with locally advanced esophageal cancer that can be removed by surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swiss Group for Clinical Cancer Research
• Treatments: Cetuximab; Cisplatin; Docetaxel

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