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

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ClinicalTrials.gov Identifier: NCT01591135
Recruitment Status : Active, not recruiting
First Posted : May 3, 2012
Last Update Posted : February 2, 2017
Sponsor:
Collaborators:
Jiangsu Cancer Institute & Hospital
First Affiliated Hospital of Zhejiang University
The First Affiliated Hospital of Xiamen University
Fujian Cancer Hospital
Affiliated Hospital of Jiangnan University
Fudan University Shanghai Cancer Center Minhang Branch
Information provided by (Responsible Party):
Kuai Le Zhao, MD, Fudan University

Brief Summary:
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 or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma Drug: Paclitaxel plus 5-fluorouracil Drug: Cisplatin plus 5-fluorouracil Radiation: Radiation therapy Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 436 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2012
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 3-yr overall survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Disease progression-free survival [ Time Frame: 3 years ]
  2. Local progression-free survival [ Time Frame: 3 years ]
  3. Number and grade of Participants with Adverse Events [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01591135


Locations
China, Shanghai
Fudan University Cancer Center
Shanghai, Shanghai, China
Sponsors and Collaborators
Fudan University
Jiangsu Cancer Institute & Hospital
First Affiliated Hospital of Zhejiang University
The First Affiliated Hospital of Xiamen University
Fujian Cancer Hospital
Affiliated Hospital of Jiangnan University
Fudan University Shanghai Cancer Center Minhang Branch
Investigators
Principal Investigator: Kuai Le Zhao, M.D. Fudan University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kuai Le Zhao, MD, Principal Investigator, Fudan University
ClinicalTrials.gov Identifier: NCT01591135     History of Changes
Other Study ID Numbers: ESO-Shanghai1
First Posted: May 3, 2012    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: February 2017

Keywords provided by Kuai Le Zhao, MD, 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
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Fluorouracil
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs