CCRT for Esophageal Cancer.

Phase 2

Completed

• Conditions: Paclitaxel; Esophageal Cancer; Oxaliplatin; Concurrent Chemoradiotherapy
• Interventions: Drug: Paclitaxel; Drug: Oxaliplatin; Radiation: Radiotherapy

• Registration Number: NCT02607982
• Lead Sponsor: Hangzhou Cancer Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2014-06
• Study Completion: 2015-11
• Study First Submitted: 2015-11-16
• Study First Submitted QC: 2015-11-16
• Study First Posted: 2015-11-18
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-14
• Last Update Posted: 2016-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

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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;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Concurrent Chemoradiotherapy Arm	Radiotherapy	Radiotherapy was delivered with a daily fraction of 2.0 Gy to a total dose of 60 Gy over 6 weeks. Concurrent paclitaxel (135mg/m², d1) and oxaliplatin (125mg/ m², d1) were administered on Days 1 and Day 29 of radiotherapy.
Concurrent Chemoradiotherapy Arm	Oxaliplatin	Radiotherapy was delivered with a daily fraction of 2.0 Gy to a total dose of 60 Gy over 6 weeks. Concurrent paclitaxel (135mg/m², d1) and oxaliplatin (125mg/ m², d1) were administered on Days 1 and Day 29 of radiotherapy.
Concurrent Chemoradiotherapy Arm	Paclitaxel	Radiotherapy was delivered with a daily fraction of 2.0 Gy to a total dose of 60 Gy over 6 weeks. Concurrent paclitaxel (135mg/m², d1) and oxaliplatin (125mg/ m², d1) were administered on Days 1 and Day 29 of radiotherapy.

Primary Outcome Measures

Name	Time	Method
response rate	week 4	Response rate was done after 4 weeks following the last radiotherapy session.

Secondary Outcome Measures

Name	Time	Method
Survival outcome	year 0- year 5	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.
Toxicity	year 0- year 5	Acute toxicities and late toxicities based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0).