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A Prospective multicenter, randomized controlled Phase II Trial Comparing Preoperative Chemoradiotherapy Followed by Surgery to Surgery Followed by Postoperative Chemoradiotherapy for Esophageal Cancer

A Prospective multicenter, randomized controlled Phase II Trial Comparing Preoperative Chemoradiotherapy Followed by Surgery to Surgery Followed by Postoperative Chemoradiotherapy for Esophageal Cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002665
Enrollment
Unknown
Registered
2012-10-03
Start date
2012-01-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ESCC

Interventions

A:Preoperation Neoadjuvant
B:Post operation Neoadjuvant

Sponsors

Zhejiang Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Tumour histologically documented squamous cell carcinoma of the thoracic esophagus must be resectable;The pre-treatment clinical stage must be T3-4N0-1M0 or T1-2N1M0; 2. No anti-tumor therapy received; 3. Estimated survival time more than six months; 4. Aged 18 to 65 years old; 5. WBC>=4.0*10^9/l, ANC>=1.5*10^9/l, PLT>=100.0*10^9/l, Hb>=90g/l; hepatorenal function is normal; 6. KPS>80; 7. The patient can understand the research and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Already received anti-tumor therapy (including chemotherapy,radiotherapy,surgery); 2. Known or suspected allergy to chemotherapy drug like taxol,carboplatin,etc; 3. Already existed or merged with hemorrhagic disease; 4. Female patients in pregnancy or lactating; 5. Without informed consent due to psychology, family, community, etc; 6. Can't use the stomach for replacing esophagus due to previous surgery; 7. Patients with peripheral neuropathy, CTC grade>=2; 8. With a history of other malignancies before enrollment, except for non-melanoma skin cancer, in situ cervical cancer; 9. Researchers consider the patient unsuitable to participate.

Design outcomes

Primary

MeasureTime frame
PFS;QOL;

Secondary

MeasureTime frame
OS;Safety of Treatment;

Countries

China

Contacts

Public ContactMao Weiming
maowmzj1218@163.com+86 0571-88122032

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 8, 2026