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Trial Title:
Phase III Study of Neo-adjuvant Chemoradiotherapy Followed by Surgery for Squamous Cell Esophageal Cancer
NCT ID:
NCT01216527
Condition:
Squamous Cell Esophageal Carcinoma
Conditions: Official terms:
Carcinoma
Esophageal Neoplasms
Conditions: Keywords:
Stage IIB or III squamous cell esophageal carcinoma.
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
Neo-adjuvant Chemoradiotherapy followed by Surgery
Description:
1. Radiotherapy combined with concomitant chemotherapy:
Radiotherapy Program:External radiation with a total dose of 40.0Gy is given in 20
fractions of 2.0Gy,5 fractions a week.
neo-chemotherapy program: Vinorelbine 25mg/m2, IV (in the vein) on day 1 and day 8
of each 21 day cycle. Cisplatin 75mg/m2,IV DRIP on day 1 of each 21 day cycle;or
Cisplatin 25mg/m2,IV DRIP on day 1 to day 4 of each 21 day cycle.
Number of cycles:two
2. surgery:Mckeown Modification Surgery and total two-field lymphadenectomy
Arm group label:
experimental group
Intervention type:
Procedure
Intervention name:
surgery
Description:
two field lymphadenectomy
Arm group label:
control group
Summary:
The primary objective is to compare neo-adjuvant chemoradiotherapy followed by surgery
versus surgery, in terms of the overall survival time (OS) in patients with Stage IIB or
III squamous cell esophageal carcinoma.
Detailed description:
Esophageal cancer (EC) is the eighth most common cancers in the world, with more than
480,000 new cases and 400,000 deaths occurred annually worldwide. In China, every year,
no matter new cases or deaths account for more than half of the world. Besides, over 90%
of Chinese patients have esophageal squamous cell carcinoma (ESCC).
Surgery is the main treatment of this disease, but the prognosis of patients with locally
advanced esophageal cancer is rather poor. As a result of surgery alone, the 5-year
survival rate of about 25% has not changed significantly in several decades.
Preoperative chemoradiotherapy followed by surgery seems to hopefully improve the
survival of EC. Nevertheless, the results of different studies were inconsistent.
Recently, the CROSS trial has demonstrated that preoperative chemoradiotherapy can
significantly increased the overall survival of patients with EC compared with surgery
alone. It should be noticed that only 84 cases(23%) of ESCC were enrolled in this trial
with potential minimal follow-up of 2 years, which may be not perfect to evaluate the
effect of this combined therapy for this tumor type.
Up till now, vinorelbine has no indications for esophageal cancer, although, some studied
have reported its effect and feasibility to the therapy of EC. Vinorelbine has similar
mechanism with paclitaxel and docetaxel, which are recommended for the chemotherapy of EC
by NCCN. They are all classified as antimicrotubule agents, which cause mitotic arrest
and eventual cell death through inhibition of microtubule dynamics. In comparison with
the taxanes, vinorelbine has obvious advantage of few cardiac toxicity. This should be
beneficial to prevent cardiac side effects of chemoradiotherapy, especially for the
middle or lower thoracic EC, which account for over 70% of thoracic EC in China. For this
group of patients, radiotherapy can hardly avoid cardiac toxicity.
Based on our preliminary study, we have demonstrated the validity and safety of
vinorelbine and cisplatin-based neoadjuvant chemoradiotherapy.
We are to carry out a phased III clinical trial to investigate the effect of this
multidisciplinary therapy for the overall survival of patients with locally advanced
ESCC.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage IIB or
III, which is potentially resectable.
2. Patients must not have received any prior anticancer therapy.
3. More than 6 months of expected survival.
4. Age ranges from 18 to 70 years.
5. Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets
≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney.
6. Karnofsky performance status (KPS) of 90 or more.
7. Signed informed consent document on file.
Exclusion Criteria:
1. Patients are diagnosed or suspected to be allergic to cisplatin or vinorelbine.
2. Patients with concomitant hemorrhagic disease.
3. Pregnant or breast feeding.
4. Inability to use gastric conduit after esophagectomy because of a prior surgery.
5. Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more.
6. Have a prior malignancy other than esophageal carcinoma, carcinoma in situ of the
cervix, nonmelanoma skin cancer or cured early stage of prostate cancer.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen Uniersity Cancer Center
Address:
City:
GuangZhou
Zip:
510060
Country:
China
Facility:
Name:
Cancer Hospital of Shantou University Medical College
Address:
City:
Shantou
Zip:
515000
Country:
China
Start date:
June 2007
Completion date:
December 2019
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
Affiliated Cancer Hospital of Shantou University Medical College
Agency class:
Other
Collaborator:
Agency:
Shanghai Chest Hospital
Agency class:
Other
Collaborator:
Agency:
Fudan University
Agency class:
Other
Collaborator:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Taizhou Hospital
Agency class:
Other
Collaborator:
Agency:
The Second People's Hospital of Sichuan
Agency class:
Other
Collaborator:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01216527
