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A Randomized Phase II Trial Evaluating an Organ-conserving Strategy With Radiotherapy + CDDP + Gemcitabine vs Radiotherapy + CDDP in Muscle-infiltrative Bladder Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Infiltrating Bladder Urothelial Carcinoma

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Trial Information

A Randomized Phase II Trial Evaluating an Organ-conserving Strategy With Radiotherapy + CDDP + Gemcitabine vs Radiotherapy + CDDP in Muscle-infiltrative Bladder Cancer


Inclusion Criteria:



- Muscle invasive urothelial cancer (front line or following the progression of a
superficial tumor), pT2-pT3 stage without lymphatic impairment (N0) and without
detectable metastases (M0). An optimal macroscopic resection (TURB) have to be
performed

- The proof of invasive tumor to the muscle should be brought by a transurethral
resection under anaesthesia less than 8 weeks before or, in the absence, by
superficial biopsies and formal imaging. Multiples biopsies in the bladder must also
be performed.

- Age ≥ 18 years

- Life expectancy ≥ 6 months

- Kanorfsky index ≥ 70 % (WHO 0, 1, 2)

- Biological criteria: neutrophils ≥ 1500/mm3, Platelets ≥ 100 000/mm3, haemoglobin ≥
10 g/dl, creatinine clearance > 60 ml/mn

- No distant metastases (Thorax, abdomen, and pelvic CT-scan, bone scan)

- Efficient contraception for premenopausal women, maintained during the whole
treatment and up to two months after the completion of radiotherapy.

- No radiotherapy or chemotherapy history except for in situ bladder lesions.

- No carcinological history except for non melanoma skin tumours, in situ uterine
cervix cancer

- No contraindication to gemcitabine or cisplatin.

- No contraindication to radiotherapy

- Information letter and informed consent signed

- Patient covered by social security

Exclusion Criteria:

- Bladder tumors without any muscle infiltration

- Epidermoid carcinoma or adenocarcinoma

- Distance metastases or extrapelvic node positivity

- Severe digestive history (ulcerative colitis, complicated diverticulitis)

- Pregnancy and breast feeding

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Disease-free survival

Outcome Description:

The time to relapse is defined as the time from the date of randomisation to the date of the first event. Time to relapse for patients without any event (local, regional, distance, or death) will be censored at the date of latest information.

Outcome Time Frame:

Two years after the end of the complete therapeutic sequence

Safety Issue:

No

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

GETUG V04

NCT ID:

NCT01495676

Start Date:

September 2011

Completion Date:

September 2019

Related Keywords:

  • Infiltrating Bladder Urothelial Carcinoma
  • Bladder cancer
  • Organ-conserving strategy
  • Radiochemotherapy
  • non metastatic
  • Urinary Bladder Neoplasms
  • Carcinoma
  • Carcinoma, Transitional Cell

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