CCRT for Esophageal Cancer.

Esophageal Cancer Clinical Trial

Official title:

Long-term Results of Definitive Concurrent Chemoradiotherapy Using Paclitaxel Plus Oxaliplatin in Unresectable Locally Advanced Esophageal Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02607982
• Other study ID #: HangzhouCH03
• Status: Completed
• Phase: Phase 2
• First received: November 16, 2015
• Last updated: February 14, 2016
• Start date: January 2005
• Est. completion date: November 2015

Study information

• Verified date: February 2016
• Source: Hangzhou Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aimed at assessing the efficiency and safety of concurrent chemoradiotherapy (CCRT) using paclitaxel (PTX) plus oxaliplatin (OHP) in unresectable locally advanced esophageal cancer patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: November 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Cytologically or histologically confirmed esophageal carcinoma

2. Age of 20 -80

3. ECOG performance status: 0-1;

4. No treatments prior to enrollment;

5. At least one measurable lesion on CT, MRI or esophageal barium exam;

6. Normal functions of heart, lung, liver, kidney and bone marrow

7. Blood exams qualified for chemotherapy, which included hemoglobulin =9 g/dl, neutrophil =1.5×109/L and platelet (PLT) =100×109/L, creatinine =1.5 UNL

8. Informed consent signed

Exclusion Criteria:

1. Prior treatments of chemotherapy or irradiation;

2. Poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable;

3. Contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis;

4. Participating in other clinical trials;

5. Pregnancy, breast feeding, or not adopting birth control;

6. Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities

7. The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin;

Related Conditions & MeSH terms

• Concurrent Chemoradiotherapy
• Esophageal Cancer
• Esophageal Neoplasms
• Oxaliplatin
• Paclitaxel

Intervention

Drug:
• Paclitaxel
PTX 135 mg/m2 was administered intravenously over 3 hours on Day 1 and Day 29 with standard premedications.
• Oxaliplatin
oxaliplatin (125mg/ m²) was given as a 2 hours infusion. Chemotherapy was started concurrently with radiation on day 1.

Radiation:
• Radiotherapy
Radiotherapy was given concurrently on the first day of the first cycle of chemotherapy. The GTV received 60Gy (30 fractions at 2Gy per fraction) and CTV was 40 Gy (20 fractions at 2Gy per fraction). Radiotherapy was delivered in three-dimensional conformal technique (3D-CRT) and no intensity-modulated radiotherapy was used.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Cancer Hospital

References & Publications (1)

Zhang P, Xie CY, Wu SX. [Concurrent chemoradiation with paclitaxel and platinum for locally advanced esophageal cancer]. Zhonghua Zhong Liu Za Zhi. 2007 Oct;29(10):773-7. Chinese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate	Response rate was done after 4 weeks following the last radiotherapy session.	week 4
Secondary	Survival outcome	Progression-free survival (PFS) was calculated from the date of CCRT initiation to the date of documented failure (local recurrence or metastasis occurrence) or the date of the last follow-up for those remaining. Overall survival (OS) was determined as the time (in months) between the first day of therapy and the last follow-up or the date of death.	year 0- year 5
Secondary	Toxicity	Acute toxicities and late toxicities based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0).	year 0- year 5