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Phase 3
18 Years
76 Years
Open (Enrolling)
Both
Gynaecologic or Digestive Pelvic Cancer

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Trial Information


Inclusion Criteria:



- Histologically proved locally advanced gynaecologic or digestive tumours (epidermoid
carcinomas, adenocarcinomas, neuroendocrine tumours, sarcomas or melanomas), (cervix,
vagina, rectal, anal).

- Locally recurrent tumours for which surgical treatment will be mutilating or marginal
(R1 or R2) and/or for cervix cancer, primary tumours non accessible for standard
treatment (radiotherapy- chemotherapy - brachytherapy and surgery).

- Surgically resectable tumour (R0 type) but for which patient does not agree with
surgery.

- Patients aged over 18 and under 76 ans

- Performance OMS Index ≤ 2

- Normal biologic parameters

- Good general and cardiac state (ASA I or II and NYHA I or II)

Exclusion Criteria:

- Surgically resectable tumour (RO) or peritoneal tumour extension or distant
metastasis.

- Cardiac or vascular pathology

- Pulmonary disease

- Uncontrolled Sepsis disease

- Pregnancy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

survival

Authority:

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

Study ID:

PIP2

NCT ID:

NCT00949039

Start Date:

February 2009

Completion Date:

February 2011

Related Keywords:

  • Gynaecologic or Digestive Pelvic Cancer
  • Pelvic Neoplasms

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