CRP on Radiobiological and Clinical Studies on Viral-Induced Cancer's Response to Radiotherapy
1 other identifier
interventional
601
11 countries
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2005
Longer than P75 for phase_3
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2005
CompletedFirst Posted
Study publicly available on registry
July 22, 2005
CompletedStudy Start
First participant enrolled
November 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedOctober 14, 2011
October 1, 2011
4.6 years
July 19, 2005
October 13, 2011
Conditions
Outcome Measures
Primary Outcomes (5)
Clinical Outcome
5 years
Treatment Toxicity
3 months
Molecular markers that will predict tumor control/resistance
5 years
Whether E6 and E7 viral proteins predict cellular radiosensitivity in oxic and hypoxic conditions in vitro and tumor control/resistance in vivo
5 years
Effectiveness of a questionnaire template on a computer in face-to-face interviews in a multicentre multinational study.
2 years
Study Arms (4)
EBR plus 2 HDBT fractions
EXPERIMENTALExternal Beam Radiotherapy High Dose Brachytherapy (2 fractions of 9Gy)
EBR plus 4 fractions HDBT
ACTIVE COMPARATORExternal Beam Radiotherapy High Dose Brachytherapy (4 fractions of 7Gy)
EBR/2 HDBT fractions/Chemotherapy
EXPERIMENTALExternal Beam Radiation High Dose Brachytherapy (2 fractions of 9Gy) Cisplatin
EBR/4 fractions HDBT/chemotherapy
EXPERIMENTALExternal Beam Radiation High Dose Brachytherapy (4 fractions of 7Gy) Cisplatin
Interventions
External Beam Radiation 46Gy in 23 daily fractions High Dose Brachytherapy 2 fractions of 9Gy
External Beam Radiation 46Gy in 23 daily fractions High Dose Brachytherapy 2 fractions of 9Gy Cisplatin 40 mg/sqm weekly
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
University of Vienna; Department of Radiotherapy and Radiobiology
Vienna, Austria
rmandade de Santa Casa de Misericordia de Porto Alegre; Hospital Santa Rita
Porto Alegre, Brazil
Peel Regional Cancer Centre
Mississauga, Ontario, Canada
Department of Atomic Energy (DAE); Tata Memorial Centre (TMC); Tata
Mumbai, India
Institut National d'Oncologie
Rabat, Morocco
Radiotherapy and Oncology University Clinic
Skopje, North Macedonia
Bahawalpur Institute of Nuclear Medicine and Oncology (BINO)
Bahawalpur, Pakistan
Instituto Nacional de Enfermedades Neoplásicas
Lima, Peru
Department of Radiation Oncology, Groote Schuur Hospital
Cape Town, South Africa
National Cancer Center
Seoul, South Korea
Christie Hospital; NHS Trust
Manchester, United Kingdom
Related Publications (7)
Nag S, Chao C, Erickson B, Fowler J, Gupta N, Martinez A, Thomadsen B; American Brachytherapy Society. The American Brachytherapy Society recommendations for low-dose-rate brachytherapy for carcinoma of the cervix. Int J Radiat Oncol Biol Phys. 2002 Jan 1;52(1):33-48. doi: 10.1016/s0360-3016(01)01755-2.
PMID: 11777620BACKGROUNDNag S, Erickson B, Thomadsen B, Orton C, Demanes JD, Petereit D. The American Brachytherapy Society recommendations for high-dose-rate brachytherapy for carcinoma of the cervix. Int J Radiat Oncol Biol Phys. 2000 Aug 1;48(1):201-11. doi: 10.1016/s0360-3016(00)00497-1.
PMID: 10924990BACKGROUNDPetereit DG, Pearcey R. Literature analysis of high dose rate brachytherapy fractionation schedules in the treatment of cervical cancer: is there an optimal fractionation schedule? Int J Radiat Oncol Biol Phys. 1999 Jan 15;43(2):359-66. doi: 10.1016/s0360-3016(98)00387-3.
PMID: 10030262BACKGROUNDWhitney CW, Sause W, Bundy BN, Malfetano JH, Hannigan EV, Fowler WC Jr, Clarke-Pearson DL, Liao SY. Randomized comparison of fluorouracil plus cisplatin versus hydroxyurea as an adjunct to radiation therapy in stage IIB-IVA carcinoma of the cervix with negative para-aortic lymph nodes: a Gynecologic Oncology Group and Southwest Oncology Group study. J Clin Oncol. 1999 May;17(5):1339-48. doi: 10.1200/JCO.1999.17.5.1339.
PMID: 10334517BACKGROUNDMorris M, Eifel PJ, Lu J, Grigsby PW, Levenback C, Stevens RE, Rotman M, Gershenson DM, Mutch DG. Pelvic radiation with concurrent chemotherapy compared with pelvic and para-aortic radiation for high-risk cervical cancer. N Engl J Med. 1999 Apr 15;340(15):1137-43. doi: 10.1056/NEJM199904153401501.
PMID: 10202164BACKGROUNDGreen JA, Kirwan JM, Tierney JF, Symonds P, Fresco L, Collingwood M, Williams CJ. Survival and recurrence after concomitant chemotherapy and radiotherapy for cancer of the uterine cervix: a systematic review and meta-analysis. Lancet. 2001 Sep 8;358(9284):781-6. doi: 10.1016/S0140-6736(01)05965-7.
PMID: 11564482BACKGROUNDPearcey R, Brundage M, Drouin P, Jeffrey J, Johnston D, Lukka H, MacLean G, Souhami L, Stuart G, Tu D. Phase III trial comparing radical radiotherapy with and without cisplatin chemotherapy in patients with advanced squamous cell cancer of the cervix. J Clin Oncol. 2002 Feb 15;20(4):966-72. doi: 10.1200/JCO.2002.20.4.966.
PMID: 11844818BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Eduardo H. Zubizarreta, M.D.
International Atomic Energy Agency (IAEA)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2005
First Posted
July 22, 2005
Study Start
November 1, 2005
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
October 14, 2011
Record last verified: 2011-10