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Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy Concurrent With Chemotherapy for Esophageal Squamous Cell Carcinoma

NCT ID: NCT02916511

Last Updated: 2023-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2023-07-01

Brief Summary

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The purpose of this study is to evaluate safety and 2-year local control rate for extensive clinical target volumes in postoperative radiotherapy concurrent with chemotherapy for esophageal squamous cell carcinoma.

Detailed Description

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Conditions

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Esophageal Squamous Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chemo-radiation group

A total dose of 45Gy will be delivered in 25 fractions at 1.8Gy/fraction, 5 fractions per week in 5 weeks.

The CTV encompassed the bilateral supraclavicular region, all mediastinal lymph nodes, the anastomosis site, and the left gastric and celiac nodes.

Paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; Carboplatin AUC=2, ivgtt, d1; qw\*5

Group Type EXPERIMENTAL

Paclitaxel

Intervention Type DRUG

paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1, qw\*5

Carboplatin

Intervention Type DRUG

carboplatin AUC=2, ivgtt, d1, qw\*5

Radiotherapy

Intervention Type RADIATION

1.8Gy/d, d1-5/week, 25Fx

Interventions

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Paclitaxel

paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1, qw\*5

Intervention Type DRUG

Carboplatin

carboplatin AUC=2, ivgtt, d1, qw\*5

Intervention Type DRUG

Radiotherapy

1.8Gy/d, d1-5/week, 25Fx

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Joined the study voluntarily and signed informed consent form;
* Age 18-75;
* ECOG 0-2;
* Esophageal squamous cell carcinoma, radical surgery ≤ 3 months, R0 resection;
* The operative incision healed well;
* T3-4N0M0, T1-4N1-3M0 (according to AJCC2009);
* No radiotherapy, chemotherapy or other treatments pre (post) surgery;
* PS ECOG 0-2;
* Life expectancy of more than 3 months;
* Hemoglobin (Hb) ≥ 9 g/dL • WBC ≥ 3 x 109/L, Neutrophils (ANC ) ≥ 1.5 x 109/L • platelet count (Pt) ≥ 100 x 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 after surgery, Esophageal perforation, Haematemesis;
* 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;
* Unsuitable to be enrolled in the trial in the opinion of the investigators.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Kuai Le Zhao, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fudan Universtiy Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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Ai D, Chen Y, Liu Q, Deng J, Zhang X, Zhang J, Chu L, Shen J, Ma L, Zhang Y, Chen H, Miao L, Zhao K, Xiang J. Extensive clinical target volume in postoperative chemoradiotherapy for esophageal squamous cell carcinoma: a phase II clinical trial (ESO-Shanghai 9). Radiat Oncol. 2023 Feb 7;18(1):26. doi: 10.1186/s13014-023-02211-w.

Reference Type DERIVED
PMID: 36750858 (View on PubMed)

Other Identifiers

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ESO-Shanghai9

Identifier Type: -

Identifier Source: org_study_id