Study of Docetaxel or Vinorelbine Plus Cisplatin in Neoadjuvant Chemoradiotherapy for Esophageal Cancer (NEOCRTEC308)

January 11, 2024 updated by: Yang Hong, Sun Yat-sen University

A Phase III Clinical Trial of Docetaxel Plus Cisplatin Versus Vinorelbine Plus Cisplatin in Neoadjuvant Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma (NEOCRTEC308)

The primary objective is to compare docetaxel plus cisplatin (DP) versus vinorelbine plus cisplatin (NP) in neoadjuvant chemoradiotherapy, in terms of the overall survival and toxicity in patients with Stage IIB or III squamous cell esophageal carcinoma.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Esophageal cancer (EC) is the eighth most common cancers in the world, with more than 456,000 new cases and 400,000 deaths occurred annually worldwide. Every year in China, 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).

Preoperative chemoradiotherapy (CRT) followed by surgery can hopefully improve the survival of ESCC. The CROSS trial has demonstrated that preoperative chemoradiotherapy can significantly increase the overall survival of patients with EC compared with surgery alone. The therapeutic effects were also found in 84 ESCC cases enrolled in this trial. Previously, the investigators performed a phase III, randomized clinical trial (NCT01216527) to compare the overall survival of stage IIB-III ESCC patients treated with or without neoadjuvant CRT, in which vinorelbine plus cisplatin was used as chemotherapy regime. The enrollment was completed in 2014. The outcomes will hopefully prove the survival benefit of neoadjuvant CRT to ESCC.

However, the investigators also observed that some patients suffer from the toxic response of neoadjuvant therapy, such as myelosuppression (45.2%), pulmonary toxicity (42.9%), and esophagitis (59.5%). The toxicity caused by CRT will decrease the patient compliance; moreover increase the perioperative complications and deaths, which may totally offset the survival benefit. Therefore, it is important to improve chemoradiotherapy effect and reduce toxicity, so as to achieve better survival in ESCC patients.

Docetaxel draws increasing attentions with its high effective rate and low toxicity. Several Phase II clinical trials and retrospective studies suggested that docetaxel showed better survival benefits in both monotherapy and combined-therapy in EC patients. Therefore, the investigators intended to conduct a phase III, randomized clinical trial to further explore whether docetaxel plus cisplatin would be an effective therapy with lower toxicity.

The investigators are to carry out a phased III clinical trial to compare the effect and toxicity of docetaxel plus cisplatin with vinorelbine plus cisplatin in neoadjuvant chemoradiotherapy for esophageal squamous cell carcinoma.

Study Type

Interventional

Enrollment (Estimated)

610

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-Sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage T1-4aN1-3M0 or T4aN0M0, according to 7th edition of Union for International Cancer Control (UICC) staging system.
  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. WHO performance status (PS) of 0-1
  7. Signed informed consent document on file

Exclusion Criteria:

  1. Patients have received any prior anticancer therapy
  2. Patients with advanced inoperable or metastatic esophageal carcinoma
  3. Patients with concomitant hemorrhagic disease
  4. Patients with other uncontrollable status that cannot tolerate surgery
  5. Pregnant or breast feeding
  6. Patients cannot signed the informed consent document because of psychological quality, family and social factors
  7. Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more
  8. Have a prior malignancy other than esophageal carcinoma, carcinoma in situ of the cervix, nonmelanoma skin cancer or cured early stage of prostate cancer
  9. Have a history of diabetes over 10 years and with poorly controlled blood sugar level
  10. patients with serious cardiac, respiratory, hepatic, renal, hematologic, immunological disease or cachexy, who cannot tolerate chemoradiotherapy or surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A (DP-RT)

• Arm A consists of the concurrent chemoradiotherapy prior to surgery. The patient will receive 4 weeks of radiation therapy and 4 weekly cycles of chemotherapy. The radiation will generally commence on the 1st day of treatment and will run for 4 weeks. Chemotherapy is given by intravenous infusion on days 1, 8, 15, and 22.

Interventions:

  • Radiation: (44 Gy/20 fractions)
  • Drug: Docetaxel
  • Drug: Cisplatin
Drug: Docetaxel
25mg/ m2 Docetaxel dose administered on days 1, 8, 15, and 22.
Other Names:
  • Docetaxel in Arm A
Drug: Cisplatin
25mg/ m2 on days 1, 8, 15 and 22.
Other Names:
  • Cisplatin in Arm A
Radiation: Radiation
Patient will receive 4 weeks of radiation therapy (44 Gy/20 fractions).
Other Names:
  • IMRT
Procedure: Surgery
McKeown esophagectomy, Ivor Lewis esophagectomy or minimally invasive esophagectomy will be performed 4-8 weeks after chemoradiotherapy. Two-field lymphadenectomy with total mediastinal lymph node dissection is performed during surgery.
Other Names:
  • Esophagectomy
Drug: Cisplatin
75mg/ m2 on day 1 of each cycle only (i.e. every 21 days).
Other Names:
  • Cisplatin in Arm B
Experimental: B (NP-RT)

• Arm B consists of the concurrent chemoradiotherapy followed by surgery. The patient will receive 4 weeks of radiation therapy and 2 cycles of chemotherapy. The radiation will generally commence on the 1st day of treatment and will run for 4 weeks. Each cycle of chemotherapy lasts 21 days/3 weeks. The drugs include Vinorelbine and Cisplatin.

Interventions:

  • Radiation: (44 Gy/20 fractions)
  • Drug: Vinorelbine
  • Drug: Cisplatin
Drug: Cisplatin
25mg/ m2 on days 1, 8, 15 and 22.
Other Names:
  • Cisplatin in Arm A
Radiation: Radiation
Patient will receive 4 weeks of radiation therapy (44 Gy/20 fractions).
Other Names:
  • IMRT
Procedure: Surgery
McKeown esophagectomy, Ivor Lewis esophagectomy or minimally invasive esophagectomy will be performed 4-8 weeks after chemoradiotherapy. Two-field lymphadenectomy with total mediastinal lymph node dissection is performed during surgery.
Other Names:
  • Esophagectomy
Drug: Cisplatin
75mg/ m2 on day 1 of each cycle only (i.e. every 21 days).
Other Names:
  • Cisplatin in Arm B
Drug: Vinorelbine
25mg/ m2 on days 1, 8 of each cycle (i.e. every 21 days).
Other Names:
  • Vinorelbine in Arm B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: At end of trial- up to 3 years in follow up
Overall survival will be calculated from the date of randomisation and an event registered on the date of death from any cause. Patients lost to follow up, or those with no death recorded on the day the database is frozen, will be censored on the date of last follow up.
At end of trial- up to 3 years in follow up
Toxicities of neo-adjuvant chemoradiotherapy
Time Frame: Within the first 56 days after the start of chemoradiotherapy
All symptoms of toxicity will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) Version. 3.0.
Within the first 56 days after the start of chemoradiotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease free survival
Time Frame: At end of trial- up to 3 years in follow up
At end of trial- up to 3 years in follow up
Clinical response rate
Time Frame: 4-6 weeks after completion of chemoradiotherapy
4-6 weeks after completion of chemoradiotherapy
R0 resection rate
Time Frame: One week after the operation
One week after the operation
Number of Participants who withdraw the treatment
Time Frame: Within the first 84 days after the start of chemoradiotherapy
Within the first 84 days after the start of chemoradiotherapy
Perioperative complication
Time Frame: Within the first 90 days after the start of surgery
Within the first 90 days after the start of surgery
Pathological complete response rate
Time Frame: One week after the operation
One week after the operation
Health Related Quality of Life
Time Frame: Within the first 84 days after the start of chemoradiotherapy
Within the first 84 days after the start of chemoradiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Hong Yang, Ph.D., M.D., Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

May 30, 2015

First Submitted That Met QC Criteria

June 4, 2015

First Posted (Estimated)

June 8, 2015

Study Record Updates

Last Update Posted (Actual)

January 16, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEOCRTEC-2.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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