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

NCT ID: NCT00122772

Last Updated: 2011-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

601 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cervix Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EBR plus 2 HDBT fractions

External Beam Radiotherapy High Dose Brachytherapy (2 fractions of 9Gy)

Group Type EXPERIMENTAL

Radiotherapy

Intervention Type RADIATION

External Beam Radiation 46Gy in 23 daily fractions

High Dose Brachytherapy 2 fractions of 9Gy

EBR plus 4 fractions HDBT

External Beam Radiotherapy High Dose Brachytherapy (4 fractions of 7Gy)

Group Type ACTIVE_COMPARATOR

Radiotherapy

Intervention Type RADIATION

External Beam Radiotherapy 46Gy in 23 daily fractions

High Dose Brachytherapy 4 fractions of 7Gy

EBR/2 HDBT fractions/Chemotherapy

External Beam Radiation

High Dose Brachytherapy (2 fractions of 9Gy)

Cisplatin

Group Type EXPERIMENTAL

Radiotherapy/Cisplatin

Intervention Type RADIATION

External Beam Radiation 46Gy in 23 daily fractions

High Dose Brachytherapy 2 fractions of 9Gy

Cisplatin 40 mg/sqm weekly

EBR/4 fractions HDBT/chemotherapy

External Beam Radiation

High Dose Brachytherapy (4 fractions of 7Gy)

Cisplatin

Group Type EXPERIMENTAL

Radiotherapy/Cisplatin

Intervention Type RADIATION

External Beam Radiotherapy 46Gy in 23 daily fractions

High Dose Brachytherapy 4 fractions of 7Gy

Cisplatin 40mg/sqm weekly

Interventions

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Radiotherapy

External Beam Radiation 46Gy in 23 daily fractions

High Dose Brachytherapy 2 fractions of 9Gy

Intervention Type RADIATION

Radiotherapy

External Beam Radiotherapy 46Gy in 23 daily fractions

High Dose Brachytherapy 4 fractions of 7Gy

Intervention Type RADIATION

Radiotherapy/Cisplatin

External Beam Radiation 46Gy in 23 daily fractions

High Dose Brachytherapy 2 fractions of 9Gy

Cisplatin 40 mg/sqm weekly

Intervention Type RADIATION

Radiotherapy/Cisplatin

External Beam Radiotherapy 46Gy in 23 daily fractions

High Dose Brachytherapy 4 fractions of 7Gy

Cisplatin 40mg/sqm weekly

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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International Atomic Energy Agency

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eduardo H. Zubizarreta, M.D.

Role: STUDY_DIRECTOR

International Atomic Energy Agency (IAEA)

Locations

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University of Vienna; Department of Radiotherapy and Radiobiology

Vienna, , Austria

Site Status

rmandade de Santa Casa de Misericordia de Porto Alegre; Hospital Santa Rita

Porto Alegre, , Brazil

Site Status

Peel Regional Cancer Centre

Mississauga, Ontario, Canada

Site Status

Department of Atomic Energy (DAE); Tata Memorial Centre (TMC); Tata

Mumbai, , India

Site Status

Institut National d'Oncologie

Rabat, , Morocco

Site Status

Radiotherapy and Oncology University Clinic

Skopje, , North Macedonia

Site Status

Bahawalpur Institute of Nuclear Medicine and Oncology (BINO)

Bahawalpur, , Pakistan

Site Status

Instituto Nacional de Enfermedades Neoplásicas

Lima, , Peru

Site Status

Department of Radiation Oncology, Groote Schuur Hospital

Cape Town, , South Africa

Site Status

National Cancer Center

Seoul, , South Korea

Site Status

Christie Hospital; NHS Trust

Manchester, , United Kingdom

Site Status

Countries

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Austria Brazil Canada India Morocco North Macedonia Pakistan Peru South Africa South Korea United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 11777620 (View on PubMed)

Nag 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.

Reference Type BACKGROUND
PMID: 10924990 (View on PubMed)

Petereit 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.

Reference Type BACKGROUND
PMID: 10030262 (View on PubMed)

Whitney 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.

Reference Type BACKGROUND
PMID: 10334517 (View on PubMed)

Morris 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.

Reference Type BACKGROUND
PMID: 10202164 (View on PubMed)

Green 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.

Reference Type BACKGROUND
PMID: 11564482 (View on PubMed)

Pearcey 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.

Reference Type BACKGROUND
PMID: 11844818 (View on PubMed)

Related Links

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http://www.iaea.org

International Atomic Energy Agency, Research Contracts Administration

Other Identifiers

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E33026

Identifier Type: -

Identifier Source: org_study_id