CCRT for Esophageal Cancer.

NCT ID: NCT02607982

Last Updated: 2016-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2015-11-30

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.

Conditions

Esophageal Cancer; Concurrent Chemoradiotherapy; Oxaliplatin; Paclitaxel

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Concurrent Chemoradiotherapy Arm

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.

Group Type: EXPERIMENTAL

Paclitaxel

Intervention Type: DRUG

PTX 135 mg/m2 was administered intravenously over 3 hours on Day 1 and Day 29 with standard premedications.

Oxaliplatin

Intervention Type: DRUG

oxaliplatin (125mg/ m²) was given as a 2 hours infusion. Chemotherapy was started concurrently with radiation on day 1.

Radiotherapy

Intervention Type: RADIATION

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.

Interventions

Paclitaxel

PTX 135 mg/m2 was administered intravenously over 3 hours on Day 1 and Day 29 with standard premedications.

Intervention Type: DRUG

Oxaliplatin

oxaliplatin (125mg/ m²) was given as a 2 hours infusion. Chemotherapy was started concurrently with radiation on day 1.

Intervention Type: DRUG

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.

Intervention Type: RADIATION

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hangzhou Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shixiu Wu

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: BACKGROUND

PMID: 18396692 (View on PubMed)

Other Identifiers

HangzhouCH03

Identifier Type: -

Identifier Source: org_study_id