Clinical trial NCT00548821: Randomized Trial Between Weekly and 5 Day 3 Weekly Cisplatin for Cervical Cancer
Official title: A Phase III Randomized Trial Between 5 Day 3 Weekly and Weekly Cisplatin Based Chemotherapy for Patients With Locally Advanced Cervical Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Locally Advanced Cervical Cancer
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2007-10-24
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary aim of this research protocol is to compare if there is a difference in progression free survival between weekly versus 5-day 3 weekly cisplatin based chemotherapy regimen in women with locally advanced cervical cancer. The secondary aims are to compare quality of life assessment of patients and their carers as well as toxicity profiles both acute and late.


Eligibility criteria: Inclusion Criteria:

* stage IB2-IVA , histological proven cervical carcinoma
* no previous diagnosis of carcinoma
* no prior history of chemotherapy or radiotherapy
* ECOG less than or equal to 2
* Above 21 years old
* medically fit for radical concurrent Cisplatin based chemotherapy and radiotherapy
* Hemoglobin \>10g/dL
* Adequate hematological, renal and hepatic function according to all of the following laboratory values:

  * Absolute neutrophil count ≥ 1.5 ×109/l
  * Platelets ≥ 100 ×109/l
  * Serum creatinine ≤ 1.5 times upper limit of laboratory normal
  * Total serum bilirubin ≤ 1.5 times upper limit of laboratory normal
  * ASAT(AST) or ALAT(ALT) ≤ 2.5 times upper limit of laboratory normal
  * Alkaline phosphatase of ≤ 2.5 times upper limit of laboratory normal

Exclusion Criteria:

* Age below 21
* Presence of known HIV infection, chronic hepatitis B or hepatitis C infection
* Psychological, familial, sociological, or geographical condition that would preclude study participation
* Prior (within the last 3 years) or simultaneous malignancies (other then cutaneous basal cell carcinoma or non-invasive tumors)
* Patients with the following histologies are excluded: small cell, carcinoid, glassy cell, clear cell and adenoid cystic.
* Life expectancy \< 6 months
* Patients with insulin dependent diabetes
* Prior tumor-directed surgery
* Previous systemic chemotherapy or pelvic radiation therapy
* As radiation and cytotoxic agents are contraindicated in pregnancy, pregnant women are ineligible and those of childbearing potential should use contraception

Primary outcomes:
measure: The primary aim of this research protocol is to compare if there is a difference in progression free survival between weekly versus 5-day 3 weekly cisplatin based chemotherapy regimen in women with locally advanced cervical cancer.
Secondary outcomes:
measure: The secondary aims are to compare quality of life assessment of patients and their carers as well as toxicity profiles both acute and late.
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: NUH
name: Johann Tang
role: PRINCIPAL_INVESTIGATOR
References: