A Phase ?Single-centered Randomized Controlled Trials of Concurrent Chemoradiotherapy with S-1 Plus Cisplatin (PS1 Regimen) Compared to 5-fluorouracil Plus Cisplatin (PF Regimen) in Non-operable Esoph

A Phase ?Single-centered Randomized Controlled Trials of Concurrent Chemoradiotherapy with S-1 Plus Cisplatin Compared to 5-fluorouracil Plus Cisplatin in Non-operable Esophageal Carcinoma

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-11001492

Enrollment

Unknown

Registered

2011-08-27

Start date

2011-10-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Esophageal carcinoma

Interventions

Group B:Concurrent chemoradiotherapy with PF regimen

Group A:Concurrent chemoradiotherapy with PS1 regimen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologic diagnosis of esophageal carcinom; 2. Patients must not have received any prior anticancer therapy; 3.There is at least one measurable lesion; 4. Age ranges from 18 to 75 years, both male and female; 5. Zubrod performance status =4.0*10^9/L, neutrophil >=1.5*10^9/L, hemoglobin >=90g/L, platelets >=100.0*10^9/L; A total serum bilirubin level within normal limits, serum alanine amino transferase, glutamic oxalacetic transaminase and alkaline phosphatase level <=2.5 times the upper limit of normal (ULN) in non liver-metastatic condition and <=5 times the upper limit of normal (ULN) in liver-metastatic condition; blood urea nitrogen and serum creatinine level <= 1.5 times the upper limit of normal (ULN); 9. Pregnancy tests negative in women of reproductive age.

Exclusion criteria

Exclusion criteria: 1. Patients have received anti-tumor therapy including chemotherapy, radiotherapy and surgery; 2. Patients are diagnosed or suspected to be allergic to cisplatin or 5-FU; 3. Patients are being treated with drugs interacted with S-1; 4. Patients with brain metastasis; 5. Patients with serious medical diseases or acute infectious diseases; 6. Pregnant and lactation women; 7. Women of reproductive age and men who reject contraceptives; 8. Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more; 9. Have a prior malignancy other than esophageal carcinoma, carcinoma in situ of the cervix, nonmelanoma skin cancer or cured early stage of prostate cancer.

Design outcomes

Primary

Measure	Time frame
Progression-free survival;Short term treatment effect;	—

Secondary

Measure	Time frame
3-year survival rate;Overall survival;5-year survival rate;	—

Countries

China

Contacts

Public ContactLIN Zhi-xiong, Chen Lei

zxlin5@yahoo.com+86 754 88555844-1138

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026