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Prospective Randomized Phase Ⅱ Trial Comparing Preoperative Chemoradiotherapy (Paclitaxel and Carboplatin) Followed by Surgery to Surgery Followed by Postoperative Chemoradiotherapy (Paclitaxel and Carboplatin) for Esophageal Cancer


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Esophageal Cancer

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Trial Information

Prospective Randomized Phase Ⅱ Trial Comparing Preoperative Chemoradiotherapy (Paclitaxel and Carboplatin) Followed by Surgery to Surgery Followed by Postoperative Chemoradiotherapy (Paclitaxel and Carboplatin) for Esophageal Cancer


Patient Population:

Thoracic esophageal cancer able to tolerate tri-modality therapy; Clinical stage T3-4, N0-1,
M0

Scheme:

Patients are randomized to 2 arms:

Arm A:

Paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f) followed by surgery,
consolidate paclitaxel/carboplatin 2 cycles.

Arm B:

Surgery followed by paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f),
consolidate paclitaxel/carboplatin 2 cycles.


Inclusion Criteria:



- Histologically documented squamous cell carcinoma or adenocarcinoma of the thoracic
esophagus (> 20cm from the incisors) or gastroesophageal junction are included.

- No distant metastases (M0).

- Patients will be stratified by stage (clinical N0 versus clinical N1).

- Patients with tumours within 3 cm distal spread into gastric cardia as detected by
esophagogastroscopy.

- Resectable mediastinal nodes are eligible.

- No prior chemotherapy for this malignancy.

- No prior radiotherapy that would overlap the field(s) treated in this study.

- Patients with other malignancies are eligible only if > 5 years without evidence of
disease or completely resected or treated non-melanoma skin cancer.

- Age > 18 years and able to tolerate tri-modality therapy at the discretion of the
treating thoracic surgeon, medical and radiation oncologists. Tumours must be
resectable after assessment by the thoracic surgeon.

Exclusion Criteria:

- Cancers of the cervical esophagus (< 20 cm are excluded).

- Tumours that have > 3 cm of spread into cardia of the stomach are considered gastric
cancers and are ineligible.

- Patients with biopsy (by endoscopic ultrasound, laparoscopy, or laparotomy ) proven
metastatic supraclavicular nodes are ineligible.

- Patients with biopsy proven metastatic celiac nodes are ineligible.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Scores of Quality of life

Outcome Description:

Assess the quality of life based on FACT-E.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Weimin Mao, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Zhejiang Cancer Hospital

Authority:

China: Food and Drug Administration

Study ID:

ZhejiangCH09

NCT ID:

NCT01463501

Start Date:

October 2011

Completion Date:

December 2016

Related Keywords:

  • Esophageal Cancer
  • Esophageal cancer
  • Resectable
  • Neoadjuvant chemoradiotherapy
  • Adjuvant chemoradiotherapy
  • Esophageal Diseases
  • Esophageal Neoplasms

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