A Phase III Study of Comparing Paclitaxel Plus 5-Fluorouracil Versus Cisplatin Plus 5-Fluorouracil in Chemoradiotherapy for Locally Advanced Esophageal Carcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by Fudan University
Sponsor:
Information provided by (Responsible Party):
Kuai Le Zhao, MD, Fudan University
ClinicalTrials.gov Identifier:
NCT01591135
First received: April 18, 2012
Last updated: May 2, 2012
Last verified: May 2012
  Purpose

The primary objective of this trial is to study whether paclitaxel plus 5-fluorouracil has better overall survival than cisplatin plus 5-fluorouracil in chemoradiotherapy for patients with locally advanced esophageal squamous cell carcinoma. 436 patients will be recruited into this study.


Condition Intervention Phase
Esophageal Squamous Cell Carcinoma
Drug: Paclitaxel plus 5-fluorouracil
Drug: Cisplatin plus 5-fluorouracil
Radiation: Radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Randomized Clinical Trial of Comparing Paclitaxel Plus 5-Fluorouracil Versus Cisplatin Plus 5-Fluorouracil in Chemoradiotherapy for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • 1-yr overall survivals [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 2-yr overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 3-yr overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease progression-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Local progression-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Number and grade of Participants with Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 436
Study Start Date: April 2012
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cisplatin
Chemoradiotherapy with cisplatin and 5-fluorouracil for 2 cycles followed by adjuvant chemotherapy for 2 cycles.
Drug: Cisplatin plus 5-fluorouracil
cisplatin 25 mg/m2/d, d1-3, once every 4 weeks for 4 cycles (week 1, week 5, week 9 and week 13); 5-FU 600 mg/m2/d, d1-3, continuously infusion for 72 hrs,once every 4 weeks for 4 cycles (week 1, week 5, week 9 and week 13).
Radiation: Radiation therapy
A total dose of 61.2 Gy will be delivered in 34 fractions at 1.8 Gy/fraction, 5 fractions per week in 6.8 weeks.
Experimental: Paclitaxel
Patients randomized in Arm B will receive chemoradiation with weekly paclitaxel and 5-fluorouracil for 5 weeks followed by adjuvant chemotherapy with paclitaxel and 5-fluorouracil for 2 cycles.
Drug: Paclitaxel plus 5-fluorouracil
5-fluorouracil 300 mg/m2, d1-4, continuous infusion for 96 hours and paclitaxel 50 mg/m2 over 3 hours, d1 (week 1, week 2, week 3, week 4 and week 5); 5-fluorouracil 600 mg/m2/d d1-3 and paclitaxel 175 mg/m2 d1(week 9 and week 13).
Radiation: Radiation therapy
A total dose of 61.2 Gy will be delivered in 34 fractions at 1.8 Gy/fraction, 5 fractions per week in 6.8 weeks.

Detailed Description:

Locally advanced esophageal squamous cell carcinoma. T2-4N0-1M0-1a,TxN1M0-1a,TxNxM1a (according to AJCC2002)

Scheme:

Eligible recurrent patients with esophageal cancer will first be stratified by nodal staging (N0 or N1), then randomized to 2 arms at 1:1 ratio.

Arm Cisplatin:

Chemoradiotherapy with cisplatin and 5-fluorouracil for 4 cycles.

Arm Paclitaxel:

Chemoradiotherapy with weekly paclitaxel and 5-fluorouracil for 5 weeks followed by adjuvant chemotherapy for 2 cycles.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Joined the study voluntarily and signed informed consent form;
  • Age 18-75
  • Both genders
  • Esophageal squamous cell carcinoma confirmed by pathology
  • Local advanced esophageal squamous cell carcinoma (T2N0M0-TxNxM1a, AJCC 2002)
  • No radiotherapy, chemotherapy or other treatments prior to enrollment
  • PS ECOG 0-2
  • Life expectancy of more than 3 months
  • Hemoglobin(Hb)≥9 g/dL
  • WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L
  • platelet count (Pt) ≥100x 109/L
  • Hepatic function: ALAT and ASAT < 2.5 x ULN, TBIL<1.5 x ULN
  • Renal function: creatinine < 1.5 x ULN
  • No immuno-deficiency
  • Use of an effective contraceptive for adults to prevent pregnancy.

Exclusion Criteria:

  • Complete esophageal obstruction
  • Deep esophageal ulcer
  • Esophageal perforation
  • Haematemesis
  • After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy
  • Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years
  • Participation in other interventional clinical trials within 30 days
  • Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
  • Drug addiction
  • Alcoholism or AIDS
  • Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
  • Patient who has metastasis such as lung, liver metastasis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01591135

Contacts
Contact: Yun Chen, M.M. 8621-64175590 ext 6726 chenyun_qz@hotmail.com

Locations
China, Shanghai
Fudan University Cancer Center Recruiting
Shanghai, Shanghai, China
Contact: Chen Yun, M.M.    8621-64175590 ext 6726    chenyun_qz@hotmail.com   
Principal Investigator: Zhao Kuai Le, M.D.         
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Kuai Le Zhao, M.D. Fudan University
  More Information

No publications provided

Responsible Party: Kuai Le Zhao, MD, Principal Investigator, Fudan University
ClinicalTrials.gov Identifier: NCT01591135     History of Changes
Other Study ID Numbers: ESO2012-01
Study First Received: April 18, 2012
Last Updated: May 2, 2012
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
Esophageal squamous cell carcinoma
chemoradiotherapy

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Cisplatin
Fluorouracil
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents

ClinicalTrials.gov processed this record on August 28, 2014