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Esophageal NeoplasmPhase 3NCT02395705

Neoadjuvant Chemotherapy Versus Surgery Alone for Esophageal Squamous Cell Carcinoma

A Phase 3 study testing cisplatin and paclitaxel in people with Esophageal Neoplasm, run by Henan Cancer Hospital at 9 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The effect of neo-adjuvant chemotherapy on survival of patients with thoracic esophageal squamous cell carcinomas remains the most controversial part of neo-adjuvant therapy for esophageal carcinomas. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Neoplasm
What is being tested?
cisplatin and paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
528 participants
Where
9 sitesChina
Study dates
Jun 2015to Oct 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage IIA to IIIB, (7th Union for International Cancer Control, UICC-TNM).
  • Patients must not have received any prior anticancer therapy of esophageal carcinoma.
  • Age ranges from 18 to 75 years.
  • Without operative contraindication.
  • 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, total bilirubin（TBIL）≤1.5N, aspartate aminotransferase (AST)≤2.5N, alanine aminotransferase(ALT)≤2.5N, prothrombin time(PT)≤1.5N, and activated partial thromboplastin time(APTT) is in normal range, endogenous creatinine clearance rate(CRE)≤1.5N.
  • Patients must not have diagnosed with other cancer and must not received any prior anticancer therapy except prostatic cancer with more than 5 years disease-free survival(DFS).
Show all 9Show fewer
  • expected R0 resection.
  • ECOG 0～2.
  • Signed informed consent document on file. 10.No metastatic lymph node in cervical by color doppler sonography.

Who cannot join

  • Multiple primary cancer.
  • The subject cannot understand and sign the informed consent form(ICF).
  • Patients with concomitant hemorrhagic disease.
  • Any un expected reason for patients can't get operation.
  • Inability to use gastric conduit after esophagectomy because of a prior surgery.
  • Pregnant or breast feeding.
  • Patients are diagnosed or suspected to be allergic to cisplatin or Paclitaxel.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

China9 sites

  • Anyang cancer hospital

    Anyang, Henan

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100029

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Hunan Province Tumor Hospital

    Changsha, Hunan, 410013

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian

  • Sun Yat-sen Uniersity Cancer Center

    Guangzhou, Guangdong, 510060

  • Fudan Universitay Shanghai Cancer Center

    Shanghai, Shanghai Municipality

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

  • Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

    Zhengzhou, Henan, 450008

Other trials in China

About this study

Official title: A Phase III, Multicenter Randomized Controlled Study of Neo-adjuvant Chemotherapy Paclitaxel + Cisplatin Versus Surgery Alone for Stage IIA-IIIB Esophageal Squamous Cell Carcinoma

The effect of neo-adjuvant chemotherapy on survival of patients with thoracic esophageal squamous cell carcinomas remains the most controversial part of neo-adjuvant therapy for esophageal carcinomas. One of our objectives is to evaluate whether the neo-adjuvant therapy with cisplatin and paclitaxel followed by right thoracic approach esophagectomy with total 2-field lymph node dissection improves the overall survival of thoracic esophageal cancer patients.

Read the detailed description

The effect of Neo-adjuvant chemotherapy on survival of patients with thoracic esophageal squamous cell carcinomas remains the most controversial part of Neo-adjuvant therapy for esophageal carcinomas. Therefore, the optimal management of resectable esophageal squamous cell carcinomas differs widely among different areas based on local randomized controlled trials.

The neo-adjuvant chemotherapy might be a good strategy if sufficient local control is achieved by surgical treatment. This study defined the detail of surgery procedure and the region of lymphadenectomy and adopted cisplatin and paclitaxel as neoadjuvant chemotherapy regimens. We try to evaluate the efficacy and safety of this neo-adjuvant strategy.

Being tested
cisplatin and paclitaxel
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cisplatin and paclitaxelDrug

    Also called TP

    1. Paclitaxel, 175mg/m2, d1, Cisplatin, 25mg/m2, d2-d4, 3 week, 2 cycles.
    2. Paclitaxel, 87.5mg/m2, d1,d8, Cisplatin, 25mg/m2, d2-d4, 3 week, 2 cycles.
    3. Paclitaxel, 175mg/m2, d1, Cisplatin, 75mg/m2, d1, 3 week, 2 cycles.
Study groups in NCT02395705
Study groupRoleWhat they receive
Neo-adjuvant chemotherapy groupExperimentalNeo-adjuvant chemotherapy(cisplatin and paclitaxel): 1. Paclitaxel, 175mg/m2, d1, Cisplatin, 25mg/m2, d2-d4, 3 week, 2 cycles. 2. Paclitaxel, 87.5mg/m2, d1,d8, Cisplatin, 25mg/m2, d2-d4, 3 week, 2 cycles. 3. Paclitaxel, 175mg/m2, d1, Cisplatin, 75mg/m2, d1, 3 week, 2 cycles. Surgery: 2-3weeks after Neo-adjuvant chemotherapy 1. Surgeons: the operation shall be performed by senior thoracic surgeons. Try to achieve the consistency of operation quality. 2. Operation: the thoracic esophagectomy must be through right thoracic cavity. (open and minimally invasive McKeown or Ivor Lewis). Total two-field lymphadenectomy (right and left recurrent laryngeal nerve lymph nodes must be included).
Receives: Drug: cisplatin and paclitaxel
Surgery alone groupNo interventionSurgery: 2-3weeks after Neo-adjuvant chemotherapy 1. Surgeons: the operation shall be performed by senior thoracic surgeons. Try to achieve the consistency of operation quality. 2. Operation: the thoracic esophagectomy must be through right thoracic cavity. (open and minimally invasive McKeown or Ivor Lewis). Total two-field lymphadenectomy (right and left recurrent laryngeal nerve lymph nodes must be included).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival rate

    Measured: 5 years

Secondary outcomes (14)

  1. Overall survival rate

    Measured: 1 years and 3 years

  2. Disease free survival

    Measured: 5 years

  3. assessment in perioperation-Removal rate (R0 resection rate)

    The R0 resection rate of two groups

    Measured: perioperative period

  4. assessment in perioperation-Rate of Operative Complication

    Complication rate after operation before discharge

    Measured: perioperative period

  5. assessment in perioperation-Mortality of perioperation

    Mortality of perioperation 20 days before operation and 30 days after operation

    Measured: perioperative period

  6. assessment in perioperation-Days of Hospitalization

    Days of Hospitalization after operation

    Measured: perioperative period

  7. assessment in perioperation-Thoracic Drainage

    Thoracic Drainage days

    Measured: perioperative period

  8. assessment in perioperation-Quantity of bleeding

    blood lose during operation

    Measured: perioperative period

  9. assessment in perioperation-Time of operation

    the time from open thoracic cavity to the closure of the thoracic cavity

    Measured: perioperative period

  10. Quality of life

    ECOG, KPS, NRS-2002, EORTC QLQ-ST018, EORTC QLQ-C30

    Measured: 1 years

  11. efficacy of neo-adjuvant chemotherapy--response rate

    Criteria:Response Evaluation Criteria in Solid Tumors，RECIST. Pathologic Complete Response Rate. Pathologic Response Rate.

    Measured: 1-4 days before operation

  12. toxicities of neo-adjuvant chemotherapy

    According to National Cancer Institute Common Terminology Criteria for Adverse Event,Version 3.0(CTC AE3.0). The complete rate of protocol

    Measured: from chemotherapy to perioperative period

  13. prognostic factors

    prognostic factors for overall survival of both groups

    Measured: 5 years

  14. predictive factors

    predictive factors for the efficiency of neo-adjuvant chemotherapy

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionOct 2022
  4. Study completionOct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
528 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02395705
Sponsor's protocol ID
Henan CH
Status last verified
Oct 2022
First submitted
26 Feb 2015
Last updated
5 Oct 2022
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cisplatin and paclitaxel in people with Esophageal Neoplasm, run by Henan Cancer Hospital at 9 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival rate (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02395705.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.

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