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Cervix CancerPhase 3NCT00122772

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

A Phase 3 study testing Radiotherapy and Radiotherapy/Cisplatin in people with Cervix Cancer, run by International Atomic Energy Agency at 11 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervix Cancer
What is being tested?
Radiotherapy and Radiotherapy/Cisplatin
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
601 participants
Where
11 sitesin 11 countries
Study dates
Nov 2005to Jun 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

11 sites in 11 countries.

11 sites in 11 countries

Austria1 site

  • University of Vienna; Department of Radiotherapy and Radiobiology

    Vienna

Other trials in Austria

Brazil1 site

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

    Porto Alegre

Other trials in Brazil

Canada1 site

  • Peel Regional Cancer Centre

    Mississauga, Ontario

Other trials in Canada

India1 site

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

    Mumbai

Other trials in India

Morocco1 site

  • Institut National d'Oncologie

    Rabat

Other trials in Morocco

North Macedonia1 site

  • Radiotherapy and Oncology University Clinic

    Skopje

Other trials in North Macedonia

Pakistan1 site

  • Bahawalpur Institute of Nuclear Medicine and Oncology (BINO)

    Bahawalpur

Other trials in Pakistan

Peru1 site

  • Instituto Nacional de Enfermedades Neoplásicas

    Lima

Other trials in Peru

South Africa1 site

  • Department of Radiation Oncology, Groote Schuur Hospital

    Cape Town

Other trials in South Africa

South Korea1 site

  • National Cancer Center

    Seoul

Other trials in South Korea

United Kingdom1 site

  • Christie Hospital; NHS Trust

    Manchester

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Conditions
Cervix Cancer
Being tested
Radiotherapy, Radiotherapy/Cisplatin
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RadiotherapyRadiation

    External Beam Radiation 46Gy in 23 daily fractions

    High Dose Brachytherapy 2 fractions of 9Gy

  • RadiotherapyRadiation

    External Beam Radiotherapy 46Gy in 23 daily fractions

    High Dose Brachytherapy 4 fractions of 7Gy

  • Radiotherapy/CisplatinRadiation

    External Beam Radiation 46Gy in 23 daily fractions

    High Dose Brachytherapy 2 fractions of 9Gy

    Cisplatin 40 mg/sqm weekly

  • Radiotherapy/CisplatinRadiation

    External Beam Radiotherapy 46Gy in 23 daily fractions

    High Dose Brachytherapy 4 fractions of 7Gy

    Cisplatin 40mg/sqm weekly

Study groups in NCT00122772
Study groupRoleWhat they receive
EBR plus 2 HDBT fractionsExperimentalExternal Beam Radiotherapy High Dose Brachytherapy (2 fractions of 9Gy)
Receives: Radiation: Radiotherapy
EBR plus 4 fractions HDBTActive comparatorExternal Beam Radiotherapy High Dose Brachytherapy (4 fractions of 7Gy)
Receives: Radiation: Radiotherapy
EBR/2 HDBT fractions/ChemotherapyExperimentalExternal Beam Radiation High Dose Brachytherapy (2 fractions of 9Gy) Cisplatin
Receives: Radiation: Radiotherapy/Cisplatin
EBR/4 fractions HDBT/chemotherapyExperimentalExternal Beam Radiation High Dose Brachytherapy (4 fractions of 7Gy) Cisplatin
Receives: Radiation: Radiotherapy/Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Outcome

    Measured: 5 years

  2. Treatment Toxicity

    Measured: 3 months

  3. Molecular markers that will predict tumor control/resistance

    Measured: 5 years

  4. Whether E6 and E7 viral proteins predict cellular radiosensitivity in oxic and hypoxic conditions in vitro and tumor control/resistance in vivo

    Measured: 5 years

  5. Effectiveness of a questionnaire template on a computer in face-to-face interviews in a multicentre multinational study.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2005 (estimated)
  2. Study startNov 2005
  3. Primary completionJun 2010
  4. Study completionJun 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
601 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00122772
Sponsor's protocol ID
E33026
Status last verified
Oct 2011
First submitted
19 Jul 2005
Last updated
14 Oct 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 11777620

  • 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.

    PubMed 10924990

  • 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.

    PubMed 10030262

  • 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.

    PubMed 10334517

  • 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.

    PubMed 10202164

  • 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.

    PubMed 11564482

  • 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.

    PubMed 11844818

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Radiotherapy and Radiotherapy/Cisplatin in people with Cervix Cancer, run by International Atomic Energy Agency at 11 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Austria, Brazil, Canada, India, Morocco and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Outcome (time frame: 5 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00122772, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2011.

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