Clinical trial NCT01463501: Neoadjuvant Versus Adjuvant Therapy in Treating Resectable Thoracic Esophageal Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Cancer
Keywords: Esophageal cancer
Resectable
Neoadjuvant chemoradiotherapy
Adjuvant chemoradiotherapy
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2011-11-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Scores of Quality of life
timeFrame: 1 year
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 1 year
Secondary outcomes:
measure: Disease-free Survival
timeFrame: 3 years
measure: Overall Survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Weimin Mao, MD
role: PRINCIPAL_INVESTIGATOR
References: