Breast CancerNCT00893035
Evaluation of an Apoptotic Test for Predicting Late Toxicities After Radiotherapy in Breast and Prostate Cancer Patients
An observational study of Breast Cancer and Prostate Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
The primary objective of this study is to evaluate the prediction of late toxicity by the radiation induced CD8 T-lymphocyte apoptosis Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Breast Cancer, Prostate Cancer
- How many people
- 885 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2006to 29 Oct 2019
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients treated in a cancer center
Who may be able to join
- localised prostate cancer, histologically proven
- Absence of metastases (M0) : normal bone scintigraphy
- Absence of radiological lymph node invasion (N0).
- Clinical Stage : T ≥ T1c-T2a and < T3b Or T1b or c with PSA ≤ 10 ng/ml . Or T1b or c with Gleason ≥ 6
- PSA < 30 ng/ml.
- Signs and symptoms according to NCI/CTC v3.0 < grade 2
Show all 20Show fewer
- ECOG Performance status ≤ 1
- Absence of hip prothesis
- Absence de endopenian stent
- Patient aged > 18 and < 80
- Patient affiliated with social security
- Written informed consent, dated and signed
- Breast Conservative surgery
- Non metastatic, M0
- negative surgical margins
- T1, T2; negative sentinel lymph node N0, N1 or N2.
- Signs and symptoms according to NCI/CTC v3.0 < grade 2
- Patient aged over 18 years and less than 60 or more than 60 with an indication for boost irradiation.
- Patient affiliated with social security
- Written informed consent, dated and signed
Who cannot join
- Antecedents of invasive cancer (unless if treated more than 5 years ago without evolution) except basocellular carcinoma
- positive biopsy of seminal vesicle
- PSA ≥ 30 ng/ml for two successive dosages
- Previous pelvic irradiation
- Previous radical prostatectomy for cancer
- Patients with another systemic disease (cardiovascular, renal, hepatic, pulmonary embolism, etc.) non stabilised or generalised sclerodermitis.
Show all 23Show fewer
- Patients known to be HIV seropositive (no specific test is necessary for defining eligibility)
- Known homozygote ATM (Ataxy telangiectasy) mutation
- Impossibility for a correct follow up (for social family or geographical reasons)
- Patients incapable of providing consent, protected majors, vulnerable persons
- Patients participating in other clinical trials
- Metastatic patients
- Bilateral breast cancer (concomitant or previous) except in situ
- T4 or N3 or treated by mastectomy
- Patients with chemotherapy or neoadjuvant hormonotherapy
- Patients with a previous other cancer within the last 5 years EXCEPT basocellular carcinoma of the skin or in situ cancer of the uterus.
- Patients with another systemic disease (cardiovascular, renal, hepatic, pulmonary embolism, etc.) non stabilised or generalised sclerodermia.
- Pregnant or breast feeding women
- Patients known to be HIV seropositive (no specific test is necessary for defining eligibility)
- Known homozygote ATM (Ataxy telangiectasy) mutation
- Impossibility for a correct follow up (for social family or geographical reasons)
- Patients incapable of providing consent, protected majors, vulnerable persons
- Patients participating in other clinical trials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Prospective Evaluation of a Predictive Test of Late Toxicities After Radiotherapy by the Rate of Radiation Induced CD8 T-Lymphocyte Apoptosis: Application to Breast and Prostate Cancers.
The primary objective of this study is to evaluate the prediction of late toxicity by the radiation induced CD8 T-lymphocyte apoptosis
Read the detailed description
The two cancer sites concerned by this trial are intermediate risk prostate cancer treated with conformational radiotherapy with or without intensity modulation, and breast cancer patients treated with adjuvant radiotherapy after breast conservative surgery for patients aged under 60 years of age. The identification of 5% of patients at risk of severe toxicity should allow to deliver high dose radiotherapy among 95% of patients with a lower risk of severe late complications.
- Conditions
- Breast Cancer, Prostate Cancer
- Keywords
- Radiotherapy, Late side effects, Predictive assay
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intermediate prognosis prostate cancer | Intermediate prognosis prostate cancer | |
| Breast cancer | conservative treatment and age<60 Boost irradiation and age>60 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late complications
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2009 (estimated)
- Study startJun 2006
- Primary completionDec 2015
- Study completion29 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 885 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Azria, Principal investigator, CRLC Val d'Aurelle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893035
- Sponsor's protocol ID
- PHRC 2005 DA
- Status last verified
- Nov 2022
- First submitted
- 4 May 2009
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Arriagada R, Mouriesse H, Sarrazin D, Clark RM, Deboer G. Radiotherapy alone in breast cancer. I. Analysis of tumor parameters, tumor dose and local control: the experience of the Gustave-Roussy Institute and the Princess Margaret Hospital. Int J Radiat Oncol Biol Phys. 1985 Oct;11(10):1751-7. doi: 10.1016/0360-3016(85)90027-6.
PubMed 4044337Azria D, Gourgou S, Sozzi WJ, Zouhair A, Mirimanoff RO, Kramar A, Lemanski C, Dubois JB, Romieu G, Pelegrin A, Ozsahin M. Concomitant use of tamoxifen with radiotherapy enhances subcutaneous breast fibrosis in hypersensitive patients. Br J Cancer. 2004 Oct 4;91(7):1251-60. doi: 10.1038/sj.bjc.6602146.
PubMed 15328527Bartelink H, Horiot JC, Poortmans P, Struikmans H, Van den Bogaert W, Barillot I, Fourquet A, Borger J, Jager J, Hoogenraad W, Collette L, Pierart M; European Organization for Research and Treatment of Cancer Radiotherapy and Breast Cancer Groups. Recurrence rates after treatment of breast cancer with standard radiotherapy with or without additional radiation. N Engl J Med. 2001 Nov 8;345(19):1378-87. doi: 10.1056/NEJMoa010874.
PubMed 11794170Buchholz TA. Finding our sensitive patients. Int J Radiat Oncol Biol Phys. 1999 Oct 1;45(3):547-8. doi: 10.1016/s0360-3016(99)00255-2. No abstract available.
PubMed 10524402Cesaretti JA, Stock RG, Lehrer S, Atencio DA, Bernstein JL, Stone NN, Wallenstein S, Green S, Loeb K, Kollmeier M, Smith M, Rosenstein BS. ATM sequence variants are predictive of adverse radiotherapy response among patients treated for prostate cancer. Int J Radiat Oncol Biol Phys. 2005 Jan 1;61(1):196-202. doi: 10.1016/j.ijrobp.2004.09.031.
PubMed 15629612Crompton NE, Ozsahin M. A versatile and rapid assay of radiosensitivity of peripheral blood leukocytes based on DNA and surface-marker assessment of cytotoxicity. Radiat Res. 1997 Jan;147(1):55-60.
PubMed 8989370Crompton NE, Shi YQ, Emery GC, Wisser L, Blattmann H, Maier A, Li L, Schindler D, Ozsahin H, Ozsahin M. Sources of variation in patient response to radiation treatment. Int J Radiat Oncol Biol Phys. 2001 Feb 1;49(2):547-54. doi: 10.1016/s0360-3016(00)01477-2.
PubMed 11173153Delanian S, Balla-Mekias S, Lefaix JL. Striking regression of chronic radiotherapy damage in a clinical trial of combined pentoxifylline and tocopherol. J Clin Oncol. 1999 Oct;17(10):3283-90. doi: 10.1200/JCO.1999.17.10.3283.
PubMed 10506631Delanian S, Porcher R, Balla-Mekias S, Lefaix JL. Randomized, placebo-controlled trial of combined pentoxifylline and tocopherol for regression of superficial radiation-induced fibrosis. J Clin Oncol. 2003 Jul 1;21(13):2545-50. doi: 10.1200/JCO.2003.06.064.
PubMed 12829674Denis F, Garaud P, Bardet E, Alfonsi M, Sire C, Germain T, Bergerot P, Rhein B, Tortochaux J, Oudinot P, Calais G. Late toxicity results of the GORTEC 94-01 randomized trial comparing radiotherapy with concomitant radiochemotherapy for advanced-stage oropharynx carcinoma: comparison of LENT/SOMA, RTOG/EORTC, and NCI-CTC scoring systems. Int J Radiat Oncol Biol Phys. 2003 Jan 1;55(1):93-8. doi: 10.1016/s0360-3016(02)03819-1.
PubMed 12504040Dewey WC, Ling CC, Meyn RE. Radiation-induced apoptosis: relevance to radiotherapy. Int J Radiat Oncol Biol Phys. 1995 Nov 1;33(4):781-96. doi: 10.1016/0360-3016(95)00214-8.
PubMed 7591884Dubray B. [Late complications of radiotherapy. Role of the time factor]. Bull Cancer Radiother. 1995;82(2):98-100. No abstract available. French.
PubMed 7546901Emami B, Lyman J, Brown A, Coia L, Goitein M, Munzenrider JE, Shank B, Solin LJ, Wesson M. Tolerance of normal tissue to therapeutic irradiation. Int J Radiat Oncol Biol Phys. 1991 May 15;21(1):109-22. doi: 10.1016/0360-3016(91)90171-y.
PubMed 2032882Fine JP. Regression modeling of competing crude failure probabilities. Biostatistics. 2001 Mar;2(1):85-97. doi: 10.1093/biostatistics/2.1.85.
PubMed 12933558Floyd DN, Cassoni AM. Intrinsic radiosensitivity of adult and cord blood lymphocytes as determined by the micronucleus assay. Eur J Cancer. 1994;30A(5):615-20. doi: 10.1016/0959-8049(94)90531-2.
PubMed 8080675
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Evaluation of a Predictive Test of Late Toxicities After Radiotherapy by the Rate of Radiation Induced CD8 T-Lymphocyte Apoptosis: Application to Breast and Prostate Cancers.
- ClinicalTrials.gov ID
- NCT00893035
- Acronym / sponsor ID
- PHRC 2005 DA
- Conditions
- Breast Cancer, Prostate Cancer
- Keywords
- Radiotherapy, Late side effects, Predictive assay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 885 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Dec 2015 (actual)
- Study completion
- 29 Oct 2019 (actual)
- First posted
- 5 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the prediction of late toxicity by the radiation induced CD8 T-lymphocyte apoptosis
Detailed description
The two cancer sites concerned by this trial are intermediate risk prostate cancer treated with conformational radiotherapy with or without intensity modulation, and breast cancer patients treated with adjuvant radiotherapy after breast conservative surgery for patients aged under 60 years of age. The identification of 5% of patients at risk of severe toxicity should allow to deliver high dose radiotherapy among 95% of patients with a lower risk of severe late complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermediate prognosis prostate cancer | – | –Intermediate prognosis prostate cancer |
| Breast cancer | – | –conservative treatment and age<60 Boost irradiation and age>60 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients treated in a cancer center
Key inclusion criteria (20 listed)
- localised prostate cancer, histologically proven
- Absence of metastases (M0) : normal bone scintigraphy
- Absence of radiological lymph node invasion (N0).
- Clinical Stage : T ≥ T1c-T2a and < T3b Or T1b or c with PSA ≤ 10 ng/ml . Or T1b or c with Gleason ≥ 6
- PSA < 30 ng/ml.
Key exclusion criteria (23 listed)
- Antecedents of invasive cancer (unless if treated more than 5 years ago without evolution) except basocellular carcinoma
- positive biopsy of seminal vesicle
- PSA ≥ 30 ng/ml for two successive dosages
- Previous pelvic irradiation
- Previous radical prostatectomy for cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Late complications
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Background: PubMed 4044337Arriagada R, Mouriesse H, Sarrazin D, Clark RM, Deboer G. Radiotherapy alone in breast cancer. I. Analysis of tumor parameters, tumor dose and local control: the experience of the Gustave-Roussy Institute and the Princess Margaret Hospital. Int J Radiat Oncol Biol Phys. 1985 Oct;11(10):1751-7. doi: 10.1016/0360-3016(85)90027-6.
- Background: PubMed 15328527Azria D, Gourgou S, Sozzi WJ, Zouhair A, Mirimanoff RO, Kramar A, Lemanski C, Dubois JB, Romieu G, Pelegrin A, Ozsahin M. Concomitant use of tamoxifen with radiotherapy enhances subcutaneous breast fibrosis in hypersensitive patients. Br J Cancer. 2004 Oct 4;91(7):1251-60. doi: 10.1038/sj.bjc.6602146.
- Background: PubMed 11794170Bartelink H, Horiot JC, Poortmans P, Struikmans H, Van den Bogaert W, Barillot I, Fourquet A, Borger J, Jager J, Hoogenraad W, Collette L, Pierart M; European Organization for Research and Treatment of Cancer Radiotherapy and Breast Cancer Groups. Recurrence rates after treatment of breast cancer with standard radiotherapy with or without additional radiation. N Engl J Med. 2001 Nov 8;345(19):1378-87. doi: 10.1056/NEJMoa010874.
- Background: PubMed 10524402Buchholz TA. Finding our sensitive patients. Int J Radiat Oncol Biol Phys. 1999 Oct 1;45(3):547-8. doi: 10.1016/s0360-3016(99)00255-2. No abstract available.
- Background: PubMed 15629612Cesaretti JA, Stock RG, Lehrer S, Atencio DA, Bernstein JL, Stone NN, Wallenstein S, Green S, Loeb K, Kollmeier M, Smith M, Rosenstein BS. ATM sequence variants are predictive of adverse radiotherapy response among patients treated for prostate cancer. Int J Radiat Oncol Biol Phys. 2005 Jan 1;61(1):196-202. doi: 10.1016/j.ijrobp.2004.09.031.
- Background: PubMed 8989370Crompton NE, Ozsahin M. A versatile and rapid assay of radiosensitivity of peripheral blood leukocytes based on DNA and surface-marker assessment of cytotoxicity. Radiat Res. 1997 Jan;147(1):55-60.
- Background: PubMed 11173153Crompton NE, Shi YQ, Emery GC, Wisser L, Blattmann H, Maier A, Li L, Schindler D, Ozsahin H, Ozsahin M. Sources of variation in patient response to radiation treatment. Int J Radiat Oncol Biol Phys. 2001 Feb 1;49(2):547-54. doi: 10.1016/s0360-3016(00)01477-2.
- Background: PubMed 10506631Delanian S, Balla-Mekias S, Lefaix JL. Striking regression of chronic radiotherapy damage in a clinical trial of combined pentoxifylline and tocopherol. J Clin Oncol. 1999 Oct;17(10):3283-90. doi: 10.1200/JCO.1999.17.10.3283.
- Background: PubMed 12829674Delanian S, Porcher R, Balla-Mekias S, Lefaix JL. Randomized, placebo-controlled trial of combined pentoxifylline and tocopherol for regression of superficial radiation-induced fibrosis. J Clin Oncol. 2003 Jul 1;21(13):2545-50. doi: 10.1200/JCO.2003.06.064.
- Background: PubMed 12504040Denis F, Garaud P, Bardet E, Alfonsi M, Sire C, Germain T, Bergerot P, Rhein B, Tortochaux J, Oudinot P, Calais G. Late toxicity results of the GORTEC 94-01 randomized trial comparing radiotherapy with concomitant radiochemotherapy for advanced-stage oropharynx carcinoma: comparison of LENT/SOMA, RTOG/EORTC, and NCI-CTC scoring systems. Int J Radiat Oncol Biol Phys. 2003 Jan 1;55(1):93-8. doi: 10.1016/s0360-3016(02)03819-1.
- Background: PubMed 7591884Dewey WC, Ling CC, Meyn RE. Radiation-induced apoptosis: relevance to radiotherapy. Int J Radiat Oncol Biol Phys. 1995 Nov 1;33(4):781-96. doi: 10.1016/0360-3016(95)00214-8.
- Background: PubMed 7546901Dubray B. [Late complications of radiotherapy. Role of the time factor]. Bull Cancer Radiother. 1995;82(2):98-100. No abstract available. French.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Azria principal investigator
CRLC Val d'Aurelle
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Prostate Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
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 20 inclusion and 23 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 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
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?
Late complications (time frame: 2 years). 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 NCT00893035, which also lists 41 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 5 Feb 2026.