CRP on Radiobiological and Clinical Studies on Viral-Induced Cancer's Response to Radiotherapy

Trial Information

CRP on Radiobiological and Clinical Studies on Viral-induced Cancer's Response to Radiotherapy With Comprehensive Morbidity Assessment

This study uses 2x2 design to test external beam radiotherapy (46 Gy in 23 daily fractions)
with and without HDR brachytherapy (2 fractions of 9 Gy versus 4 fractions of 7 Gy) with and
without weekly Cisplatin (40 mg/sqm) The overall objective was to test the clinical outcome
and toxicity of a resource-sparing schedule of radiotherapy with or without chemotherapy
treatment for cervix cancer, to detect molecular markers that will predict tumor
control/resistance and to establish whether E6 and E7 viral proteins predict cellular
radiosensitivity in oxic and hypoxic conditions in vitro and tumor control/resistance in
vivo. A new component of the CRP was added, for which the objective is to optimize the data
capture, provide more details of normal tissue outcomes following cancer treatments in
developing countries and validate this approach using patients participating in the ongoing
CRP. This will be achieved by exploring data capture using the questionnaire template on a
computer in face-to-face interviews ("active" data collection) and comparing it with
standard data collection obtained from the clinical notes ("passive" data collection) during
the still ongoing CRP E3.30.24. The method of data collection will be chosen at random for
each case stratified by centre. The reason for using an ongoing CRP is that it will test the
usefulness of the new method and validate it in a multicentre study. During the performance
of the new CRP, the same institutions as for E3.30.24 will be engaged.

Inclusion Criteria

INCLUSION CRITERIA:

- Histologically confirmed cervix cancer.

- FIGO stage IIB and IIIB

- Age over 18 years

- Karnofsky status >/= 50

- No significant medical contraindications to the administration of full dose
chemotherapy.

- Adequate bone marrow function -- Haemoglobin ³ 10 g/dl without or with transfusion,
white blood count ³ 4000/mL, platelet count ³ 140,000/mL.

- Adequate renal function: creatinine < 1.2 mg/dL or 120 μmol/l (urinary diversion is
permitted). Electrolytes and calcium within normal limits for institution. Liver
function tests if clinically indicated. Tests have to be obtained within 30 days
before registration.

- Expected good compliance for follow-up.

- Written informed consent for participation in this study.

EXCLUSION CRITERIA:

- Recent malignancy, other than the index cervical carcinoma or non-melanoma cutaneous
cancers, diagnosed within 5 years of entry

- Life expectancy <6 months, for any reason other than the index cervical carcinoma

- Any severe medical ailment, continuing pregnancy, or breast feeding, as conditions
that interfere in present treatment

- Previous chemotherapy in past 1 year

- Severe psychiatric disorder, making compliance and follow-up difficult.

- Paraaortic nodes (PAN >1 cm), suspicious or positive for metastatic involvement on
radiological imaging. (Note: patients with positive pelvic lymph nodes are still
eligible for the study, but they cannot have suspicious or positive PAN.)

- Bilateral hydronephrosis

- Prior radiation to the pelvis

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical Outcome

Outcome Time Frame:

5 years

Safety Issue:

Principal Investigator

Eduardo H. Zubizarreta, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

International Atomic Energy Agency (IAEA)

Authority:

United Nations: International Atomic Energy Agency

Study ID:

E33026

NCT ID:

NCT00122772

Start Date:

November 2005

Completion Date:

June 2010

Related Keywords:

Cervix Cancer
Uterine Cervical Neoplasms

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