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Squamous Carcinoma of EsophagusPhase 1NCT01225523

Perioperative Vs. Preoperative Chemotherapy With Surgery in the Squamous Carcinoma of Esophagus

A Phase 1 study testing Paclitaxel; Cisplatin; 5-Fluorouracil and Paclitaxel; Cisplatin; 5-Fluorouracil; Capecitabine in people with Squamous Carcinoma of Esophagus and Esophagus Disorders, run by Xi'an Jiaotong University at 1 site 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

To assess whether or not a perioperative therapy with surgery can improve the outcomes among patients with potentially curable squamous carcinoma of esophagus as compared to a preoperative chemotherapy followed by surgery Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Paclitaxel; Cisplatin; 5-Fluorouracil and Paclitaxel; Cisplatin; 5-Fluorouracil; Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
1 siteChina
Study dates
Jan 1997to Jan 2010
Phase
Phase 1
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Signed informed consent
  • histologically confirmed esophageal cancer (squamous carcinoma) measurable, non-metastatic disease
  • no previous cancer therapy (chemotherapy, radiotherapy or resection)
  • life expectancy > 3 months
  • age > 18 years
  • WHO Status ≤ 1
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  • Intended curative resection according to evaluation of an experienced surgeon
  • Negative pregnancy blood test at screening but not earlier than 72 hours prior to start of chemotherapy for women with child bearing potential
  • Adequate haematologic function and liver and renal function: neutrophils > 1.5×109/L; thrombocytes > 100×109/L; haemoglobin > 10 g/dl, creatinine clearance > 60 ml/min (calculated according to Cockroft and Gault), total bilirubin < 1.0×UNL; AST and ALT < 1.5×UNL, AP < 2.5×UNL
  • Complete staging within 3 weeks prior to start of treatment (CT-scan of thorax and abdomen, endosonography, gastroscopy)
  • Ability to keep appointments and follow the study protocol
  • By CT-scan, endoscopy or endosonography measurable or evaluable disease

Who cannot join

  • Former therapy of cancer (operation, chemo- or radiotherapy)
  • Diagnosis of another cancer in the last 5 years prior to study entry which has not been cured by operation only (exception in-situ-carcinoma of the cervix or cured non-melanomatose skin cancer)
  • Known contraindication to the planned chemotherapeutics
  • Presence of distant metastases
  • Anamnestic known serious disease or other concomitant diseases that affect participation in this study, such as:
  • oInstable cardiac disease: symptomatic heart failure, symptomatic coronary artery disease, ventricular cardiac arrhythmia not well controlled with medication, myocardial infarction or resuscitation within 6 month before study oActive infection necessitating systemic therapy or uncontrolled infection oInterstitial lung diseases (for example: pneumonitis or fibrosis of the lung) and indication for interstitial lung disease in chest x-ray or CT-scan respectively oActive inflammatory bowel disease or other bowel diseases which provoke chronic diarrhea (defined as > 4 bowel movements per day) oNeurological or psychiatric disease including dementia, epilepsy or untreated, symptomatic brain metastases oLimited hearing ability
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  • Presence of upper GI obstruction, leading to inability to swallow ground tablets
  • Presence of acute or chronic systemic infection
  • Presence of a bowel obstruction within the last 30 days
  • Pregnant or lactating women or women with child bearing potential and men without adequate contraception (high effective contraception, defined as Pearl Index < 1) like birth control pill, hormone spiral, hormone implant, transdermal patch, a combination of two barrier methods (condom and diaphragm), realized sterilization or sexual abstinence during the study and at least for 3 months after the last infusion
  • Any other situation which may lead to an unacceptable high risk for the patient, when he participates in the study
  • Parallel treatment in another clinical study or prior participation in this study
  • Treatment with any other therapy against the tumor or any parallel radiation
  • Symptomatic peripheral neuropathy NCI-CTCAE degree > 2
  • Intolerance to the study medication
  • Detention in a psychiatric unit or imprisonment

Trial locations and contacts

1 site in 1 country.

China1 site

  • First Affiliated Hospital of College of Medicine of Xi'an Jiao Tong University

    Xi'an, Shaanxi, 710061

Other trials in China

About this study

Official title: Perioperative Versus Preoperative Chemotherapy With Surgery in Patients With Locoregional Squamous Carcinoma of Esophagus

To assess whether or not a perioperative therapy with surgery can improve the outcomes among patients with potentially curable squamous carcinoma of esophagus as compared to a preoperative chemotherapy followed by surgery

Read the detailed description

Perioperative chemotherapy has been shown to significantly improve the R0 resection rate, the disease free survival and the overall survival in patients with adenocarcinoma of the esophagus, the gastroesophageal junction and the stomach. Therefore, perioperative chemotherapy is the new therapeutic standard (Cunningham NEJM 2006, MRC, Lancet 2002, Boige ASCO 2007). The best-evaluated regime is the combination of Epirubicin, Cisplatin and 5-FU (ECF) (Cunningham, NEJM 2007). Cisplatin and 5-FU are considered to be the most important components to form the cornerstone of this regime.

Paclitaxel is a new and highly active cytotoxic agent. In a randomized phase II study, the dual combination of Paclitaxel and 5-FU seemed to show similar effects as ECF, administered as first line treatment. The triplet combination of Paclitaxel, Cisplatin and 5-FU has significantly superior efficacy than a combination of Cisplatin und 5-FU (Van Cutsem, JCO 2007).

It has been shown that Capecitabine is more active than 5-FU and can replace intravenous 5-FU in the combination with Cisplatin in the treatment of esophageal cancer. Capecitabine therefore is FDA approved for esophageal cancer (Cunningham, ASCO 2006, Kang ASCO 2006).It seems reasonable to optimize perioperative chemotherapy by including this modern chemotherapeutics.

In this study, patients with squamous carcinoma of esophagus and gastroesophageal junction who seem operable with curative intent according to oncological and surgical assessment are treated with 2 preoperative cycles of PCF followed by surgical resection, followed by 2 postoperative cycles of PCF. Among patients with no responses to preoperative chemotherapy, Capecitabine 625 mg/m² twice-daily dose is defined as alternatives to infused 5-Fluorouracil in the postoperative chemotherapy regimen Postoperative chemotherapy will start within 4-6 weeks after the operation. 3 weeks after the end of the last chemotherapy the final investigation (end of study visit) will be done.

Being tested
Paclitaxel; Cisplatin; 5-Fluorouracil, Paclitaxel; Cisplatin; 5-Fluorouracil; Capecitabine
Medical subject headings
Esophageal Diseases

What participants receive

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

  • Paclitaxel; Cisplatin; 5-FluorouracilDrug

    Two preoperative cycles with Paclitaxel 200 mg/m² d1, Cisplatin 60 mg/m² d1, 5-Fluorouracil 700 mg/m² d1-5 repeated every 3 weeks followed by resection

  • Paclitaxel; Cisplatin; 5-Fluorouracil; CapecitabineDrug

    Two postoperative cycles with Paclitaxel 200 mg/m²/day d1, Cisplatin 60 mg/m²/day d1, 5-Fluorouracil 700 mg/m²/day d1-5 repeated every 3 weeks Among patients with no responses to preoperative chemotherapy, Capecitabine 625 mg/m² twice-daily dose as alternatives to infused 5-Fluorouracil in the postoperative chemotherapy regimen

Study groups in NCT01225523
Study groupRoleWhat they receive
Preoperative chemotherapy followed by surgeryActive comparatorNot described
Receives: Drug: Paclitaxel; Cisplatin; 5-Fluorouracil
Perioperative chemotherapy with surgeryActive comparatorNot described
Receives: Drug: Paclitaxel; Cisplatin; 5-Fluorouracil; Drug: Paclitaxel; Cisplatin; 5-Fluorouracil; Capecitabine

What is being measured

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

  1. Overall survival rate

    Measured: 5 years

  2. Progression-free survival

    Measured: 3 years

Secondary outcomes (6)

  1. Pathological remission rate

    Measured: After 2 cycles of preoperative chemotherapy (2 month)

  2. Resectability rate

    Measured: After 2 cycles of preoperative chemotherapy (2 month)

  3. Operative and postoperative complication rate

    Measured: Within 30 days after surgery

  4. 30-day mortality

    Measured: After date of surgery

  5. Toxicity of preoperative and postoperative chemotherapy

  6. Rate of local recurrences and metastasis

Timeline

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

  1. First posted21 Oct 2010 (estimated)
  2. Study startJan 1997
  3. Primary completionDec 2008
  4. Study completionJan 2010

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
350 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01225523
Sponsor's protocol ID
ZY-01
Status last verified
Sep 2010
First submitted
19 Oct 2010
Last updated
21 Oct 2010
Results posted
No

Publications

  • Zhao Y, Dai Z, Min W, Sui X, Kang H, Zhang Y, Ren H, Wang XJ. Perioperative versus Preoperative Chemotherapy with Surgery in Patients with Resectable Squamous Cell Carcinoma of Esophagus: A Phase III Randomized Trial. J Thorac Oncol. 2015 Sep;10(9):1349-1356. doi: 10.1097/JTO.0000000000000612.

    PubMed 26287319

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Paclitaxel; Cisplatin; 5-Fluorouracil and Paclitaxel; Cisplatin; 5-Fluorouracil; Capecitabine in people with Squamous Carcinoma of Esophagus and Esophagus Disorders, run by Xi'an Jiaotong 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 12 inclusion and 16 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 21 Oct 2010. 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 phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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). The study lists 2 primary outcomes in all. 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 NCT01225523, which also lists 1 linked publication.

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 21 Oct 2010.

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