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Esophageal CancerPhase 3PANCHONCT00525200

p53-Adjusted Neoadjuvant Chemotherapy for Potentially Resectable Esophageal Cancer

A Phase 3 study testing 5-Fluoruracil, Cisplatinum and Docetaxel in people with Esophageal Cancer, run by Daniela Kandioler at 13 sites in Austria.

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

Study Hypothesis: PANCHO is a prospective randomized, predictive marker study, evaluating the interaction between the potential predictive marker 'p53 genotype' and response to induction chemotherapy in patients with esophageal cancer considered resectable. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Cancer
What is being tested?
5-Fluoruracil, Cisplatinum and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
13 sitesAustria
Study dates
Jun 2007to Dec 2012
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological verification of esophageal cancer
  • Presence of T2,T3,T4 or any N1 (except M1)
  • Clinically measurable lesions according to RECIST criteria
  • Males and females, age >18 to 75 or older with WHO performance status 1
  • No prior tumor therapy for esophageal cancer
  • No other malignancy in history within 5 years before evaluation
Show all 10Show fewer
  • Performance status of 0-2 on ECOG scale
  • Medical fitness (adequate for possible esophageal resection, adequate organ function: see protocol)
  • Signed informed consent
  • Males and females with reproductive potential must use an approved contraceptive method. Females with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.

Who cannot join

  • Inoperability (technical or functional)
  • Clinical stage cT1N0, any M1
  • Treatment with any of the investigational drugs within the last 6 months
  • Concurrent administration of any other tumor therapy
  • Pregnancy, breast feeding
  • Serious concomitant disorders that would compromise the safety of the patient or ability to complete the study
  • Second primary malignancy that is clinically detectable at the time of consideration for study enrollment

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Austria13 sites

  • Landesklinikum Feldkirch

    Feldkirch, Vorarlberg

  • Medical University Innsbruck

    Innsbruck, Tyrol

  • Landeskrankenhaus Leoben

    Leoben, 8790

  • Krankenhaus der Elisabethinen

    Linz, 4020

  • Landesklinikum St. Pölten

    Sankt Pölten, Lower Austria, 3100

  • Krankenhaus der Barmherzigen Brüder

    Stankt Veit, 9300

  • Rudolfstiftung

    Vienna, State of Vienna, 1030

  • SMZ OST

    Vienna, State of Vienna

  • Wilhelminenspital

    Vienna, State of Vienna

  • Medical University of Vienna

    Vienna, 1090

  • Kaiser Franz Josef Spital

    Vienna, 1100

  • Hanusch Krankenhaus

    Vienna, 1140

  • Landesklinikum Wiener Neustadt

    Wiener Neustadt, Lower Austria, 2700

Other trials in Austria

About this study

Official title: p53-Adjusted Neoadjuvant Chemotherapy for Potentially Resectable Esophageal Cancer: A Multicenter, Randomized Controlled, Predictive Marker Clinical Trial

Study Hypothesis:

PANCHO is a prospective randomized, predictive marker study, evaluating the interaction between the potential predictive marker 'p53 genotype' and response to induction chemotherapy in patients with esophageal cancer considered resectable.

170 patients with measurable disease will be enrolled in this study. After testing the marker genotype (two genotypes: p53 normal or p53 mutant) patients will be stratified according to histological subtype only (adeno- or squamous cell carcinoma) and will be randomly assigned to receive 3 cycles of either 5-fluorouracil (5FU)/cisplatin or docetaxel monotherapy as neoadjuvant therapy. All patients will be rendered to subsequent surgery in order to assess both clinical and pathohistological response.

Read the detailed description

PANCHO will test the hypothesis that p53 genotype is predictive for response to chemotherapy. The study uses the marker by treatment interaction design. In this design, we assume that the status of the marker splits the whole population into two distinct groups (p53 normal versus p53 mutant).

Patients in each marker group are randomly assigned to two different treatments, and planned statistical analysis is to test whether one treatment is superior to the other within each marker group separately.

The marker information but not the treatment is blinded to the patient and the investigators.

Being tested
5-Fluoruracil, Cisplatinum, Docetaxel
Keywords
predictive marker, personalized therapy, response assessment, p53 genotype
Medical subject headings
Esophageal Neoplasms

What participants receive

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

  • 5-Fluoruracil, CisplatinumDrug

    5 FU 1000mg/m2; days 1-5; 3 cycles: q21

    Cisplatin 80mg/m2; day 1; 3 cycles: q21

  • DocetaxelDrug

    Docetaxel 75mg/m2, day 1; 3 cycles; q21

Study groups in NCT00525200
Study groupRoleWhat they receive
AActive comparatorNot described
Receives: Drug: 5-Fluoruracil, Cisplatinum
BExperimentalNot described
Receives: Drug: Docetaxel

What is being measured

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

  1. Tumor response (clinical and pathological) to neoadjuvant treatment in relation to p53 genotype

    Measured: 12 weeks

Secondary outcomes (4)

  1. Complete pathological response and relation to p53 genotype

    Measured: 12 weeks

  2. Complete tumor resection rate

    Measured: 12 weeks

  3. Perioperative morbidity and mortality

    Measured: 16 weeks

  4. Disease free and overall survival and relation to p53 genotype

    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 posted5 Sep 2007 (estimated)
  2. Study startJun 2007
  3. Primary completionMay 2012
  4. Study completionDec 2012

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
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00525200
Sponsor's protocol ID
ASSO OE-1
Other IDs
EudraCT 2006-006647-31
Acronym
PANCHO
Status last verified
Dec 2012
First submitted
4 Sep 2007
Last updated
21 Dec 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Kandioler D et al. p53 adapted neoadjuvant therapy for esophageal cancer: pilot study. JCO, vol 25, 18S: 206s

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 5-Fluoruracil, Cisplatinum and Docetaxel in people with Esophageal Cancer, run by Daniela Kandioler at 13 sites in Austria.

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 10 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 21 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Austria. 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?

Tumor response (clinical and pathological) to neoadjuvant treatment in relation to p53 genotype (time frame: 12 weeks). 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 NCT00525200, 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 Dec 2012.

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