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Phase II Study: Green Tea Intake for the Maintenance of Complete Remission in Women With Advanced Ovarian Carcinoma


Phase 2
N/A
N/A
Open (Enrolling)
Female
Ovarian Carcinoma

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Trial Information

Phase II Study: Green Tea Intake for the Maintenance of Complete Remission in Women With Advanced Ovarian Carcinoma


Inclusion Criteria:



- patients with ovarian serous carcinoma FIGO stage III or IV

- patients showing complete response after oncological surgery and chemotherapy
(paclitaxel-carboplatin, minimum 5 cycles, maximum 8 cycles), complete response being
defined as 1) a negative complete physical examination 2) Serum CA-125 levels
inferior to 35 U/mL 3) no evidence of diseased assessed by abdomino-perineal CT-scan

- patients refraining from drinking tea other than provided by the study

- patients who may absorb liquids orally

- patients without any other malignancy (except for non-melanoma skin cancer)

- patients not involved in an other study

- patients who signed up informed consent form.

Exclusion Criteria:

- exclusion criteria are implicit from inclusion criteria.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

time to relapse

Outcome Time Frame:

36 months

Safety Issue:

Yes

Principal Investigator

Bernard TĂȘtu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Université Laval

Authority:

Canada: Health Canada

Study ID:

SC-126639

NCT ID:

NCT00721890

Start Date:

June 2008

Completion Date:

June 2014

Related Keywords:

  • Ovarian Carcinoma
  • chemoprevention
  • green tea
  • relapse free-survival
  • proteases
  • Carcinoma
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

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