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Randomized Phase III Study of Gemcitabine/Cisplatine (GC) Versus High-dose Intensity Methotrexate, Vinblastine, Doxorubicine and Cisplatin (HD-MVAC) in the Perioperative Setting for Patients With Locally Advanced Transitional Cell Cancer of the Bladder


Phase 3
18 Years
80 Years
Open (Enrolling)
Both
Bladder Cancer

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Trial Information

Randomized Phase III Study of Gemcitabine/Cisplatine (GC) Versus High-dose Intensity Methotrexate, Vinblastine, Doxorubicine and Cisplatin (HD-MVAC) in the Perioperative Setting for Patients With Locally Advanced Transitional Cell Cancer of the Bladder


Inclusion Criteria:



- Primary tumour of the bladder

- Histologically confirmed infiltrating urothelial carcinoma (epidermoid and/or
glandular variants are accepted if combined with TCC)

- Disease defined by a T2, T3 or T4a N0 (lymph node £ 10 mm on CT scan) M0
stadification for patients receiving neoadjuvant chemotherapy OR pT3 or pT4 OR pN+
whatever pT and M0 for patients receiving adjuvant chemotherapy

- 18 ≤ age ≤ 80 years

- General condition 0 or 1 as per the WHO scale

- Absence of previous chemotherapy for muscle-invasive disease

- Haematological function: Haemoglobin > 11 g/dl, neutrophils ≥ 1500/mm3, platelets ≥
100,000/mm3

- Liver function: Grade* 0 ASAT and ALAT, grade* 0 alkaline phosphatases, normal
bilirubin

- Renal function: calculated (or measured) creatinine clearance ³ 40 ml/min - ---
Patients covered by a social security scheme

- Patient having read the information sheet and signed the informed consent form.

Exclusion Criteria:

- Pure adenocarcinoma or pure epidermoid carcinoma or mixed or pure small-cell
neuroendocrine carcinoma

- Ventricular ejection fraction < 50%

- History of cancer in the 5 years prior to entry in the trial other than basal cell
skin cancer or in situ epithelioma of the cervix

- Male or female patients not agreeing to use an effective method of contraception
throughout the duration of treatment and for 6 months after treatment discontinuation

- Pregnant women, or female subjects liable to become pregnant or currently
breast-feeding,

- Patient already included in another therapeutic trial on an investigational medicinal
product,

- Persons deprived of their freedom or under judicial protection (including
guardianship)

- Unable to receive medical follow-up during the trial owing to geographical, social or
psychological reasons.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS) at 3 years

Outcome Description:

Evaluation of efficacy in terms of progression-free survival at 3 years of the combination of gemcitabine and cisplatin (GC) versus high dose methotrexate, vinblastine, doxorubicin and cisplatin (HD-MVAC) as perioperative chemotherapy for locally advanced -transitional cell carcinoma of the bladder.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Christian PFISTER, MD

Investigator Role:

Study Director

Investigator Affiliation:

CCAFU

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

2011/119/HP

NCT ID:

NCT01812369

Start Date:

March 2013

Completion Date:

August 2021

Related Keywords:

  • Bladder Cancer
  • Urinary Bladder Neoplasms

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