Few results directly study the combination of docetaxel and oxaliplatin in the squamous cell cancer of the esophagus, but some studies have shown that it is safe to In the phase II study for the patients with gastroesophageal junction adenocarcinoma, The efficacy and safety of the combination therapy of docetaxel 80mg/m2 and oxaliplatin 100mg/m2 every 3 weeks schedule. Entire response rate was 34% and median survival duration was 11.6 months. Over grades 3 anemia and neutropenia were found in 17%, respectively, and non-hematological toxicities were mostly mild to moderate. In this study, a five-day preventive granulocyte colony-stimulating factor (G-CSF) was used to reduce hematology toxicity. 
Meanwhile, there was the phase I/II studies of added capecitabine to docetaxel and oxaliplatin with divided schedule d1 and d8 every 3weeks for reducing toxicities. The subjects who participated in this study had at least one previous history of chemotherapy, but overall response rates were 43% and median values for the entire duration of survival were 9.8months. However, the side effects were significant, with 30 % of patients seeing diarrhea of Grade 3 or higher and 17 % seeing infection of Grade 3 or higher (SAE) reported at 37 %. 
Looking at the reasons and background for this, the effects of docetaxel on esophageal squamous cell cancer patients are already known, and weekly divided administration has also demonstrated a reasonable level of effectiveness and safety. In studies conducted on gastric and esophageal adenocarcinoma, the combination of docetaxel and oxaliplatin also showed reasonable levels of effects and side effects. 
In this study, we wanted to look at the effects and safety of first line docetaxel and oxaliplatin weekly administration chemotherapy for the patients with inoperable or metastatic esophageal squamous cell carcinoma.

Treatment

• Docetaxel-PM 35mg/m2 D1, 8 I.V. over 1hr
 • Oxaliplatin 120mg/m2 D1 I.V. over 2hr
Every 3 weeks till progression

Arm Label

Target Number of Participant

Arm Type

Arm Description

• Docetaxel-PM 35mg/m2 D1, 8 I.V. over 1hr
 • Oxaliplatin 120mg/m2 D1 I.V. over 2hr
Every 3 weeks till progression

Gender

Age

Description

(1) A patient whose squamous cell cancer of the esophagus or esophago-gastric junction has been confirmed by biopsy or cytology.
(2) A patient who is not subject to local treatment such as surgical excision or concurrent definitive chemoradiotherapy.
(3) Metastatic or relapsed esophageal cancer patients who planned first line palliative treatment. 
(4) Patients’ age over 18
(5) Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-2 
(6) Patient has measurable lesions with Response evaluation in solid tumor (Response Evaluation Criteria in Solid Tumors) v1.1
(7) Patients with appropriate organ functions, such as the following, within seven days prior to the start of a clinical trial 
 - Proper bone marrow function (ANC ≥ 1500/uL, Platelets ≥ 100,000/uL and Hb 8/uL )
 - Proper kidney function (serum creatinine ≤ 1.5 mg/L, 24-hour urine test or creatinine clearance ≥ 60 ml/min based on Cockcroft-Gault formula)
 - Appropriate liver function (bilirubin ≤ 1.5 mg/dL, ALT and AST ≤ 2.5 times normal upper limit)
(8) Patients with at least three months of an expected life. 
(9) Signing written consent from patients or their legal guardians and understanding the right to withdraw consent at any time without disadvantage.

(1) In the case that the following treatment has been received in the past for the local stage treatment more than 6 months from the end of the treatment, enrolment is allowed.
 - Neoadjuvant chemotherapy
 - Concurrent or sequential chemoradiotherapy
 - Adjuvant chemotherapy
 - Adjuvant concurrent or sequential chemoradiotherapy
 - Definitive concurrent or sequential chemoradiotherapy
(2) Patients with a history of administration of docetaxel, paclitaxel, or oxaliplatin at any time in the past.
(3) Patients who have been treated for other active cancers other than esophageal cancer less than five years (but cured kin basal cell cancer or cured cervical CIS are excluded).
(4) The clinically confirmed esophagus obstruction, gastrointestinal bleeding, or perforation (except if the symptoms are sufficiently controlled through proper procedures such as stents).
(5) Patients with significant, uncontrolled cardiovascular disease, infection, or infectious fever.
(6) Patients with uncontrolled brain metastasis.
(7) In the case of major surgery within the first two weeks of clinical trial treatment, the patient must recover sufficiently from the effects of this surgery.
(8) Patients with pregnancy, breast feeding, or future plans.
(9) Because of uncontrolled diabetes or diabetic neuropathy, patients who have any subjective symptoms regardless of their degree 
(10) Patients who have taken antihistamine or steroid within four weeks of clinical trial treatment
(11) In combination with the state of Docetaxel-PM, patients who are not permitted to take combined medication (patients with severe renal dysfunction, para-platin, platinum compound, patients who have hypersensitivity to mannitol, etc.)
(12) Patients with hypersensitivity history of Polysorbate 80
(13) A patient who has hypersensitivity history to Docetaxel-PM or oxaliplatin or any drug containing platinum.
(14) Patients with peripheral sensory neuropathy with functional impairment (may aggravate peripheral neuropathy) prior to clinical trial
(15) Other cases
- Have experienced an infection or other serious medical problems that could cause damage to a patient's functions, making it difficult for the patient to receive treatment in a research plan.
- mental, neurological, or dementia that can prevent a person from understanding and submitting a written statement and consent form
- Patients who are certain to be out of the clinical trial or who cannot be monitored regularly for the following reasons: For example, psychological, social, family or geographical reasons, or conditions that make it difficult to observe or comply with appropriate clinical trial plans.
- Incontrolled hepatitis and chronic liver disease
- Other patients who are judged unfit for clinical trials by their physicians and researchers

overall response rate

up to 6 months

progression free survival

up to 12 months

overall survival

up to 12 months

adverse events

up to 12 months