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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
International Atomic Energy Agency
ClinicalTrials.gov Identifier:
NCT00122772
First received: July 19, 2005
Last updated: October 13, 2011
Last verified: October 2011
  Purpose

The purpose of this trial is to study clinical effects of two/four high dose rate (HDR) brachytherapy applications and teletherapy with or without weekly cisplatin in cervix cancer.


Condition Intervention Phase
Cervix Cancer
Radiation: Radiotherapy
Radiation: Radiotherapy/Cisplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CRP on Radiobiological and Clinical Studies on Viral-induced Cancer's Response to Radiotherapy With Comprehensive Morbidity Assessment

Resource links provided by NLM:


Further study details as provided by International Atomic Energy Agency:

Primary Outcome Measures:
  • Clinical Outcome [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Treatment Toxicity [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Molecular markers that will predict tumor control/resistance [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Whether E6 and E7 viral proteins predict cellular radiosensitivity in oxic and hypoxic conditions in vitro and tumor control/resistance in vivo [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Effectiveness of a questionnaire template on a computer in face-to-face interviews in a multicentre multinational study. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 601
Study Start Date: November 2005
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EBR plus 2 HDBT fractions
External Beam Radiotherapy High Dose Brachytherapy (2 fractions of 9Gy)
Radiation: Radiotherapy

External Beam Radiation 46Gy in 23 daily fractions

High Dose Brachytherapy 2 fractions of 9Gy

Active Comparator: EBR plus 4 fractions HDBT
External Beam Radiotherapy High Dose Brachytherapy (4 fractions of 7Gy)
Radiation: Radiotherapy

External Beam Radiotherapy 46Gy in 23 daily fractions

High Dose Brachytherapy 4 fractions of 7Gy

Experimental: EBR/2 HDBT fractions/Chemotherapy

External Beam Radiation

High Dose Brachytherapy (2 fractions of 9Gy)

Cisplatin

Radiation: Radiotherapy/Cisplatin

External Beam Radiation 46Gy in 23 daily fractions

High Dose Brachytherapy 2 fractions of 9Gy

Cisplatin 40 mg/sqm weekly

Experimental: EBR/4 fractions HDBT/chemotherapy

External Beam Radiation

High Dose Brachytherapy (4 fractions of 7Gy)

Cisplatin

Radiation: Radiotherapy/Cisplatin

External Beam Radiotherapy 46Gy in 23 daily fractions

High Dose Brachytherapy 4 fractions of 7Gy

Cisplatin 40mg/sqm weekly


Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122772

Locations
Austria
University of Vienna; Department of Radiotherapy and Radiobiology
Vienna, Austria
Brazil
rmandade de Santa Casa de Misericordia de Porto Alegre; Hospital Santa Rita
Porto Alegre, Brazil
Canada, Ontario
Peel Regional Cancer Centre
Mississauga, Ontario, Canada
India
Department of Atomic Energy (DAE); Tata Memorial Centre (TMC); Tata
Mumbai, India
Korea, Republic of
National Cancer Center
Seoul, Korea, Republic of
Macedonia, The Former Yugoslav Republic of
Radiotherapy and Oncology University Clinic
Skopje, Macedonia, The Former Yugoslav Republic of
Morocco
Institut National d'Oncologie
Rabat, Morocco
Pakistan
Bahawalpur Institute of Nuclear Medicine and Oncology (BINO)
Bahawalpur, Pakistan
Peru
Instituto Nacional de Enfermedades Neoplásicas
Lima, Peru
South Africa
Department of Radiation Oncology, Groote Schuur Hospital
Cape Town, South Africa
United Kingdom
Christie Hospital; NHS Trust
Manchester, United Kingdom
Sponsors and Collaborators
International Atomic Energy Agency
Investigators
Study Director: Eduardo H. Zubizarreta, M.D. International Atomic Energy Agency (IAEA)
  More Information

Additional Information:
Publications:

Responsible Party: International Atomic Energy Agency
ClinicalTrials.gov Identifier: NCT00122772     History of Changes
Other Study ID Numbers: E33026
Study First Received: July 19, 2005
Last Updated: October 13, 2011
Health Authority: United Nations: International Atomic Energy Agency

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on October 19, 2014