Multicenter Cohort Study of ESD and Chemo-radiotherapy for High-risk Early-stage Esophageal Cancer

NCT ID: NCT06385717

Last Updated: 2024-04-26

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

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2029-01-31

Brief Summary

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This multicenter, prospective observational cohort study has the potential to optimize individualized chemoradiotherapy regimen for early-stage esophageal cancer patients who have received endoscopic submucosal dissection.

Detailed Description

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Our study can further improve the local-regional lymph nodes control rate and alleviate the toxicity of chemoradiotherapy.

Conditions

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Esophagus Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Prophylactic chemoradiotherapy

pT1a -MM and pT1b-SM1 without pathological risk factors

chemo-radiation

Intervention Type RADIATION

different Chemo-radiotherapy regimen

Intensive chemoradiotherapy

pT1b-SM2; pT1a -MM and pT1b-SM1 with pathological risk factors

chemo-radiation

Intervention Type RADIATION

different Chemo-radiotherapy regimen

Radical chemoradiotherapy

Positive vertical margin or unknown margin

chemo-radiation

Intervention Type RADIATION

different Chemo-radiotherapy regimen

Interventions

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chemo-radiation

different Chemo-radiotherapy regimen

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* 1\. Esophageal cancer patients who are pathologically confirmed as pT1a-MM stage or pT1b stage after endoscopic submucosal dissection; 2. No definite contraindications for chemo-radiotherapy; 3. Informed consent has been signed; 4. Refused surgery after endoscopic submucosal dissection.

Exclusion Criteria

* 1\. Severe heart, brain, lung disease or renal dysfunction; 2. Previous history of other malignancies; 3. Prior radiation or chemotherapy 4. Researchers consider it inappropriate to participate in this experiment
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jing Xu, MD

Role: STUDY_CHAIR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

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The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

The Second Affiliated Hospital of Zhejiang University, School of Medicine

Hangzhou, , China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Jing Xu, MD

Role: CONTACT

0086-0571-87783521

Qichun Wei, PHD

Role: CONTACT

0086-0571-87783521

Facility Contacts

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Jing Xu, MD

Role: primary

0086-0571-87783521

Jing Xu

Role: primary

0086-0571-87783521

Other Identifiers

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ZhejiangU

Identifier Type: -

Identifier Source: org_study_id

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