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Efficacy and Safety of TPFinduction Chemotherapy Boundary Resectable Local Advanced Esophageal Squamous Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT02976909
Recruitment Status : Unknown
Verified January 2018 by Yuhong Li, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : November 29, 2016
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Yuhong Li, Sun Yat-sen University

Brief Summary:
Paclitaxel In combination with DDP and 5-FU(TPF) as neoadjuvant chemotherapy in treating boundary resectable locally advanced esophageal squamous cell carcinoma: A phase II clinical trial.

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma Drug: Paclitaxel+Cisplatin+5fluorouracil Phase 2

Detailed Description:
Esophageal cancer is one of the most common malignant tumor in China. In Asian countries, esophageal squamous carcinoma is the main pathological type of esophageal carcinoma. Prognosis of esophageal squamous carcinoma is usually poor and surgery is the only radical treatment. However, the optimal therapy pattern for local advanced esophageal carcinoma is still unclear. Part of the patients that clinical staging as T4 and presents multiple lymph node metastasis and esophageal carcinoma with large diameters are initially diagnosed as boundary resectable, which means patients may be able to undergo R0 resection. However, for patients who are diagnosed as boundary resectable esophageal carcinoma, there are still no sufficient studies implicate that how to improve R0 resection rate by neoadjuvant chemotherapy. DDP in combination with 5-FU and docetaxel regimen(DCF) was reported as effective neoadjuvant chemotherapy in treating esophageal squamous carcinoma. However, studies also showed that the DCF regimen caused severe adverse reaction. The mechanism of paclitaxel is similar to docetaxel while with less adverse events than docetaxel. Based on the research situation mentioned above, the investigators decided to conduct a phase II clinical trial to further explore the efficacy and safety of paclitaxel in combination with DDP and 5-FU (TPF) regimen in treating locally advanced esophageal squamous cell carcinoma.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Paclitaxel In Combination With DDP and 5-FU(TPF) as Neoadjuvant Chemotherapy in Treating Boundary Resectable Advanced Esophageal Squamous Carcinoma: A Phase II Clinical Trial
Study Start Date : November 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Paclitaxel+Cisplatin+5fluorouracil
Patients will receive the following chemotherapy: Paclitaxel 135mg/m2 IV over 3 hours on Day 1; Cisplatin 75mg/m2 IV over 1 hours on Day 1; 5-FU 4g/m2 for 5 days continuous infusion from Day 1 to Day 5.
Drug: Paclitaxel+Cisplatin+5fluorouracil
Patients will receive the following chemotherapy: Paclitaxel 135mg/m2 IV over 3 hours on Day 1; Cisplatin 75mg/m2 IV over 1 hours on Day 1; 5-FU 4g/m2 for 5 days continuous infusion from Day 1 to Day 5.
Other Names:
  • Paclitaxel
  • Cisplatin
  • 5fluorouracil




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: From the date of first drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: From the date of first drug administration until the date of death, assessed up to 36 months ]
  2. Overall response rate (ORR) [ Time Frame: From the date of first drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months ]
  3. Number of participants with AEs and SAEs as a measure of Safety [ Time Frame: Each follow up vist, assessed up to 3 years ]
    Each follow up visit, assessed up to 3 years. Date will be assessed at each study visiting using NCI CTCAE version 4.0.

  4. Quality of life using EORTC QLQ C30 - scale [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ]
    Life quality evaluation using EORTC QLQ C30 - scale,once every 1 cycle assessment

  5. Quality of life using esophageal special scale QLQ - OES18 [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ]
    Life quality evaluation using esophageal special scale QLQ - OES18, once every 1 cycle assessment



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients should be voluntary to the trial and provide with signed informed consent.
  2. Male or female patients, age:18-70 years old
  3. Confirmed by histology of thoracic esophageal squamous cell carcinoma without metastasis and diagnosed as boundary resectable by Multidisciplinary consultation, including cT4 and lymph node metastasis that may invade nearby organs(such as great vessels,trachea,etc.)
  4. Lesions can be measured according the RECIST 1.1 criteria.
  5. No previous chemotherapy or radiotherapy.
  6. Life expectancy ≥ 3 months.
  7. ECOG PS 0-1.
  8. Blood routine within 7 days:Hb ≥9g/L,NE ≥1.5×109/L,PLT ≥100×109/L;
  9. Hepatic and renal function:TB £ 1.5 UNL, Cr £ 1.5× UNL, AST / ALT £ 2.5 ´ UNL, ALP £ 5.0 ´ UNL。
  10. No severe complications such as active digestive tract hemorrhage, perforation, jaundice, gastrointestinal obstruction, non-cancerous fever > 38 ℃
  11. Fertile patients should take effective contraceptive measures.
  12. Patients should have good compliance and cooperate with the evaluation of efficacy and adverse events and follow-ups according to the research plan.

Exclusion Criteria:

  1. Cervical esophageal carcinoma.
  2. Known severe hypersensitivity to drugs in the regimen.
  3. Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment(with the exception of nonmelanoma skin cancer or cervical carcinoma in situ).
  4. Evidence of serious heart disease, including recorded history of congestive heart-failure, uncontrolled serious arrhythmia, angina that needs treatment of drugs, clinical diagnosed cardiac valve disease, history of serious myocardial infarction and intractable hypertension.
  5. Evidence of chronic diarrhea(≥4 times/day) or renal dysfunction.
  6. Evidence of active infection or active epidemic disease.
  7. Psychiatric illness that would prevent the patient from giving informed consent
  8. Pregnant or lactating women.

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): NCT02976909


Contacts
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Contact: Yu-hong Li, MD, Ph D liyh@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Yu-hong Li, MD, Ph D       liyh@sysucc.org.cn   
Principal Investigator: Yu-hong Li, MD, Ph D         
Sponsors and Collaborators
Yuhong Li
Investigators
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Principal Investigator: Yu-hong Li, MD, Ph D Sun Yat-sen University
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Responsible Party: Yuhong Li, Clinical Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02976909    
Other Study ID Numbers: TPF-1
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Fluorouracil
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs