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

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:

MedlinePlus related topics: Esophagus Disorders

Drug Information available for: Fluorouracil Cisplatin Paclitaxel

U.S. FDA Resources

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.

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

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 Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Diseases
Digestive System Diseases
Cisplatin
Fluorouracil
Paclitaxel
Antineoplastic Agents

Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 19, 2013