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

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ClinicalTrials.gov Identifier: NCT02465736
Recruitment Status : Recruiting
First Posted : June 8, 2015
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
Yang Hong, Sun Yat-sen University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma Esophageal Cancer Oesophageal Cancer Drug: Docetaxel Drug: Cisplatin Radiation: Radiation Procedure: Surgery Drug: Vinorelbine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 610 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Clinical Trial of Docetaxel Plus Cisplatin Versus Vinorelbine Plus Cisplatin in Neoadjuvant Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma
Study Start Date : July 2015
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023


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 Name: Docetaxel in Arm A

Drug: Cisplatin
25mg/ m2 on days 1, 8, 15 and 22.
Other Name: Cisplatin in Arm A

Radiation: Radiation
Patient will receive 4 weeks of radiation therapy (44 Gy/20 fractions).
Other Name: 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 Name: Esophagectomy

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
Radiation: Radiation
Patient will receive 4 weeks of radiation therapy (44 Gy/20 fractions).
Other Name: 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 Name: Esophagectomy

Drug: Vinorelbine
25mg/ m2 on days 1, 8 of each cycle (i.e. every 21 days).
Other Name: Vinorelbine in Arm B

Drug: Cisplatin
75mg/ m2 on day 1 of each cycle only (i.e. every 21 days).
Other Name: Cisplatin in Arm B




Primary Outcome Measures :
  1. 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.

  2. 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.


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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02465736


Contacts
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Contact: Hong Yang, Ph.D., M.D. yanghong@sysucc.org.cn
Contact: Ting Lin, Study nurse 86-20-87343628 linting@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Hong Yang, MD, PhD    +86+13560405144    yanghong@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Hong Yang, Ph.D., M.D. Sun Yat-sen University

Publications of Results:

Other Publications:
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Responsible Party: Yang Hong, Associate Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02465736    
Other Study ID Numbers: NEOCRTEC-2.0
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Esophageal Neoplasms
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Cisplatin
Docetaxel
Vinorelbine
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic