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Esophageal Squamous Cell CarcinomaPhase 2/3NCT02272699

Neoadjuvant Treatment of Nimotuzumab With Chemotherapy or Radiotherapy in Resectable Esophageal Squamous Cell Carcinoma

A Phase 2/3 study testing Nimotuzumab, Paclitaxel and Cisplatin in people with Esophageal Squamous Cell Carcinoma, run by Peking University at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Esophageal cancer is one of common malignant tumors in China and esophageal squamous cell carcinoma (ESCC) is the dominant pathological type, accounting for more than 95% of all cases. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Nimotuzumab, Paclitaxel and Cisplatin
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
Nov 2014to Dec 2020
Phase
Phase 2/3
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must give written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors.
  • Weight loss must be less than 10% in last 6 months.
  • With an expected life expectancy of ≥ 12 months
  • With a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale
  • Patients must have histologically confirmed esophageal squamous cell carcinoma without prior treatments including surgery, chemotherapy, radiotherapy, and targeting treatment.
  • With resectable disease of primary tumor in middle or lower thoracic esophagus and clinical stage Ⅱa-Ⅲ.
Show all 13Show fewer
  • With measurable or evaluable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
  • Without serious system dysfunction and could tolerate chemotherapy or radiotherapy.
  • Patients must have normal marrow function with a hemoglobin (HGB) of ≥90g/L, an white blood cell (WBC) counts of ≥4.0×109/L，a neutrophil count of ≥2.0×109/L, , a platelet count of ≥100×109/L, a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL), a creatinine (Cr) of ≤ 1.5 UNL, alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL.
  • Patients must have normal electrocardiogram results and no history of congestive heart failure.
  • Women of childbearing age should voluntarily take contraceptive measures.
  • Without drug addition
  • Patients must be with good compliance and agree to accept follow-up of disease progression and adverse events.

Who cannot join

  • Allergic to known drug
  • Patients who have received prior treatment including chemotherapy, radiotherapy and surgery.
  • With unresectable disease including any T4b or M1 disease.
  • Without measurable or evaluable disease.
  • With history of other tumors except for those of cervical carcinoma in situ or skin basal cell carcinoma who had been completely treated and without relapse in last 5 years.
  • With serious diseases such as congestive heart failure, uncontrolled myocardial infarction and arrhythmia, liver failure and renal failure.
  • With neurological or psychiatric abnormalities that affect cognitive.
  • Pregnant or lactated women (premenopausal women must give urine pregnancy test before enrollment)

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Cancer Hospital & Peking University Cancer Hospital

    Beijing, Beijing Municipality, 100142

Other trials in China

About this study

Official title: Neoadjuvant Treatment of Nimotuzumab With Chemotherapy or Radiotherapy Versus Surgery Alone in Resectable Esophageal Squamous Cell Carcinoma

Esophageal cancer is one of common malignant tumors in China and esophageal squamous cell carcinoma (ESCC) is the dominant pathological type, accounting for more than 95% of all cases. One of our phase Ⅱ study introduced a combination treatment of an anti epithelial growth factor receptor (EGFR) agent, nimotuzumab, with paclitaxel and cisplatin as first-line treatment in unresectable or metastatic ESCC. The results showed that the overall response rate was 51.8% (29/56) and disease control rate was 92.9% (52/56). As a median follow-up of 24 months, the median progression-free survival for patients with metastatic disease and local advanced disease were 8.2 months and more than 23 months respectively. The overall survival for patients with metastatic disease was 13.9 months. It implied that as first-line chemotherapy, an addition of nimotuzumab to chemotherapy was a more active treatment option compared to other regimens published in previous studies. Investigations by Liang, J. and Ling, Y. also suggested that nimotuzumab in combining with radiotherapy or chemotherapy also showed anti-tumor activities and limited toxicities.

Therefore, we initiated this phase Ⅱ to Ⅲ clinical trial in which combining neoadjuvant treatments of nimotuzumab with chemotherapy or nimotuzumab with radiotherapy are compared with surgery alone for resectable stage Ⅱa to Ⅲ middle and lower thoracic esophageal squamous cell carcinoma patients. We hope to explore if these neoadjuvant combination treatments could bring survival benefit for ESCC patients.

Being tested
Nimotuzumab, Paclitaxel, Cisplatin, Radiation, Surgery
Keywords
Esophageal Squamous Cell Carcinoma, Nimotuzumab, Neoadjuvant treatment
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

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

  • NimotuzumabDrug

    Also called h-R3

    Nimotuzumab 200mg per week for 6 weeks.

  • PaclitaxelDrug

    Also called Taxol

    Paclitaxel 175mg per square metre on day 1, repeated every 3 weeks for 2 cycles.

  • CisplatinDrug

    Also called CDDP

    Cisplatin 30mg per square metre on day 1 and day 2, repeated every 3 weeks for 2 cycles.

  • RadiationRadiation

    IMRT of primary tumor and local lymph nodes with 95% PTV of 41.4 Gy/23f. Nimotuzumab 200mg per week for 6 weeks.

  • SurgeryProcedure or surgery

    Esophagectomy

Study groups in NCT02272699
Study groupRoleWhat they receive
Nimotuzumab with ChemotherapyExperimentalPatients will receive neoadjuvant chemotherapy of paclitaxel and cisplatin with concurrent nimotuzumab. Paclitaxel 175mg per square metre on day 1 and cisplatin 30mg per square metre on day 1 and day 2 every 3 weeks for 2 cycles. Nimotuzumab 200mg per week for 6 weeks. After neoadjuvant treatment, patients will be evaluated by a multidisciplinary teams (MDTs) and esophagectomy will be given for patients with resectable disease.
Receives: Drug: Nimotuzumab; Drug: Paclitaxel; Drug: Cisplatin; Procedure: Surgery
Nimotuzumab with radiotherapyExperimentalPatients will receive neoadjuvant radiotherapy with concurrent nimotuzumab. Intensity-modulated radiation therapy(IMRT) of primary tumor and local lymph nodes with 95% planning target volume (PTV) of 41.4 Gy/23f. Nimotuzumab 200mg per week for 6 weeks. After neoadjuvant treatment, patients will be evaluated by a multidisciplinary teams (MDTs) and esophagectomy will be given for patients with resectable disease.
Receives: Drug: Nimotuzumab; Radiation: Radiation
Surgery aloneActive comparatorPatients in this group will be given esophagectomy without any neoadjuvant treatment. Adjuvant radiotherapy is permit for patients with positive lymph nodes metastasis.
Receives: Procedure: Surgery

What is being measured

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

  1. Disease-free survival

    From the date of randomization until the date of first documented relapse of disease or date of death from any cause, whichever came first. An expected average of 2 years.

    Measured: 2 years

Secondary outcomes (4)

  1. Overall survival

    From the date of randomization until the date of death from any cause. An expected average of 3 years.

    Measured: 3 years

  2. Pathological complete response of neoadjuvant treatment

    From the date of randomization until the date of pathological diagnosis is reported after esophagectomy. An expected average of 4 months.

    Measured: 4 months

  3. The R0 resection rate

    From the date of randomization to one week after the surgical resection of tumor (esophagectomy). An expected average of 3 months.

    Measured: 3 months

  4. Numbers of adverse events and the degree of each adverse events according to the NCI CTCAE 4.0 criteria.

    From the date of randomization to 3 months after esophagectomy. An expected average of 6 months.

    Measured: 6 months

Timeline

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

  1. First posted23 Oct 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionDec 2020
  4. Study completionDec 2020

Why it stopped: Because there are questions about adjuvant radiotherapy in this study, the clinical trial is under re-design.

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02272699
Sponsor's protocol ID
ESCC002
Status last verified
Mar 2021
First submitted
11 Oct 2014
Last updated
18 Mar 2021
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Nimotuzumab, Paclitaxel and Cisplatin in people with Esophageal Squamous Cell Carcinoma, run by Peking University at 1 site 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 13 inclusion and 8 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: withdrawn, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was withdrawn before enrolling participants, so there are no results.

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?

Disease-free survival (time frame: 2 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 NCT02272699.

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 18 Mar 2021.

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