p53-Adjusted Neoadjuvant Chemotherapy for Potentially Resectable Esophageal Cancer (PANCHO)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer |
Drug: 5-Fluoruracil, Cisplatinum Drug: Docetaxel |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | p53-Adjusted Neoadjuvant Chemotherapy for Potentially Resectable Esophageal Cancer: A Multicenter, Randomized Controlled, Predictive Marker Clinical Trial |
- Tumor response (clinical and pathological) to neoadjuvant treatment in relation to p53 genotype [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Complete pathological response and relation to p53 genotype [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Complete tumor resection rate [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Perioperative morbidity and mortality [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
- Disease free and overall survival and relation to p53 genotype [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 170 |
| Study Start Date: | June 2007 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: A |
Drug: 5-Fluoruracil, Cisplatinum
5 FU 1000mg/m2; days 1-5; 3 cycles: q21 Cisplatin 80mg/m2; day 1; 3 cycles: q21 |
| Experimental: B |
Drug: Docetaxel
Docetaxel 75mg/m2, day 1; 3 cycles; q21
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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
Contacts and Locations| Austria | |
| Landesklinikum St. Pölten | |
| St. Polten, Lower Austria, Austria, 3100 | |
| Landesklinikum Wiener Neustadt | |
| Wiener Neustadt, Lower Austria, Austria, 2700 | |
| Medical University Innsbruck | |
| Innsbruck, Tirol, Austria | |
| Landesklinikum Feldkirch | |
| Feldkirch, Vorarlberg, Austria | |
| Landeskrankenhaus Leoben | |
| Leoben, Austria, 8790 | |
| Krankenhaus der Elisabethinen | |
| Linz, Austria, 4020 | |
| Krankenhaus der Barmherzigen Brüder | |
| Stankt Veit, Austria, 9300 | |
| Kaiser Franz Josef Spital | |
| Vienna, Austria, 1100 | |
| Hanusch Krankenhaus | |
| Vienna, Austria, 1140 | |
| Rudolfstiftung | |
| Vienna, Austria, 1030 | |
| Medical University of Vienna | |
| Vienna, Austria, 1090 | |
| SMZ OST | |
| Vienna, Austria | |
| Wilhelminenspital | |
| Vienna, Austria | |
| Study Chair: | Daniela Kandioler, Prof., MBA | ASSO Representative, MUW, p53research Head |
| Study Director: | Johannes Zacherl, Prof. | Medical University of Vienna, MUV |
| Study Director: | Michael Hejna, Prof. | MUW |
More Information
Additional Information:
Publications:
| Responsible Party: | Daniela Kandioler, Univ. Prof. Dr., MBA, Medical University of Vienna |
| ClinicalTrials.gov Identifier: | NCT00525200 History of Changes |
| Other Study ID Numbers: | ASSO OE-1, EudraCT 2006-006647-31 |
| Study First Received: | September 4, 2007 |
| Last Updated: | December 20, 2012 |
| Health Authority: | Austria: Federal Ministry for Health and Women |
Keywords provided by Medical University of Vienna:
|
predictive marker personalized therapy response assessment p53 genotype |
Additional relevant MeSH terms:
|
Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Head and Neck Neoplasms Docetaxel Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013