Clinical trial NCT02586753: Paclitaxel or S1 Plus Cisplatin in Concurrent Chemoradiotherapy for Squamous Cell Carcinoma of Esophagus
Official title: A Phase II Study to Compare Paclitaxel or S1 Plus Cisplatin in Concurrent Chemoradiotherapy for Squamous Cell Carcinoma of Esophagus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Lead sponsor: Mianyang Central Hospital
Sponsor class: OTHER
First posted: 2015-10-26
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine which regimen is better for esophageal squamous carcinoma in concurrent chemoradiation(CCRT),paclitaxel or S1 plus cisplatin.

Detailed description: Radiotherapy:Patients will be conducted CT simulation, and three-dimensional conformal radiation therapy (3DCRT) was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.

Chemotherapy: Patients will be concurrently administered with irradiation every 3 weeks with PT regimen (cisplatin of 20 mg/m2/d, d1-3; PTX(paclitaxel)of 135mg/m2/d, d1) for 4 cycles or PS regimen (cisplatin of 20 mg/m2/d, d1-3; S1(Tegafur Gimeracil Oteracil Potassium Capsule)of 50mg/m2/d, d1-14) for 4 cycles. For the first 2-cycles of chemotherapy they will be concurrently given with irradiation and the remained 2 cycles, after irradiation.

Eligibility criteria: Inclusion Criteria:

1. Pathologically proven squamous cell carcinoma of esophagus .
2. Locally advanced esophageal cancer , with no operation indication
3. M1a disease defined ( AJCC 1998) , including celiac lymph node for lower thoracic esophageal cancer and cervical lymph node involvement for upper thoracic esophageal cancer
4. Subjects haven't been given neither radiotherapy nor chemotherapy before
5. Age of 18-70
6. PS ≦2
7. Hemogram : WBC≧ 4000/mm3 or ANC ≧ 2000 /mm3 and Platelet ≧ 100,000/mm3 . Biochemistry : GOT/GPT ≦ 3.5 times , Cr ≦ 1.5 mg/dl and Bilirubin ≦ 2.0 mg/dl
8. With no difficulty in eating
9. Expected lifetime ≧3 months

Exclusion Criteria:

1. Invasion to surrounding organ ( T4 disease ) .
2. Distant metastasis , except M1a disease .
3. Complete obstruction of the esophagus, or patients who have the potential to develop perforation
4. Women in status of pregnancy
5. Patients who have complications exist as following:

   * Uncontrolled angina and heart failure, have a history of hospitalization in 3 months
   * A history of myocardial infarction in the past 6 months
   * There is a need for antibiotic treatment of acute bacterial or fungal infection
   * Chronic obstructive pulmonary disease, or other lung disease requiring hospitalization
   * Drug addiction, alcoholism and AIDS disease or long-term virus carriers
   * Uncontrollable seizures, or loss of insight because of mental illness

Primary outcomes:
measure: Overall survival (OS)
timeFrame: five years after enrollment
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: five years after enrollment
Other outcomes:
Locations:
Study officials:
affiliation: Mianyang Central Hospital
name: Bo X Du, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Conroy T, Yataghene Y, Etienne PL, Michel P, Senellart H, Raoul JL, Mineur L, Rives M, Mirabel X, Lamezec B, Rio E, Le Prise E, Peiffert D, Adenis A. Phase II randomised trial of chemoradiotherapy with FOLFOX4 or cisplatin plus fluorouracil in oesophageal cancer. Br J Cancer. 2010 Oct 26;103(9):1349-55. doi: 10.1038/sj.bjc.6605943. Epub 2010 Oct 12.