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The primary objective of this study is to evaluate the prediction of late toxicity by the radiation induced CD8 T-lymphocyte apoptosis
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermediate prognosis prostate cancer | Intermediate prognosis prostate cancer | ||
| Breast cancer | conservative treatment and age<60 Boost irradiation and age>60 |
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| Measure | Description | Time Frame |
|---|---|---|
| Late complications | 2 years |
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Inclusion Criteria for prostate cancer patients:
Exclusion Criteria for prostate cancer patients:
Inclusion Criteria for breast cancer patients:
Exclusion Criteria for breast cancer patients:
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patients treated in a cancer center
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| Name | Affiliation | Role |
|---|---|---|
| David Azria | CRLC Val d'Aurelle | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRLC Val d'Aurelle | Montpellier | 34000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 4044337 | Background | 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. | |
| 15328527 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 12903007 | Background | Trotti A, Colevas AD, Setser A, Rusch V, Jaques D, Budach V, Langer C, Murphy B, Cumberlin R, Coleman CN, Rubin P. CTCAE v3.0: development of a comprehensive grading system for the adverse effects of cancer treatment. Semin Radiat Oncol. 2003 Jul;13(3):176-81. doi: 10.1016/S1053-4296(03)00031-6. |
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| 3350731 | Background | Withers HR, Taylor JM, Maciejewski B. Treatment volume and tissue tolerance. Int J Radiat Oncol Biol Phys. 1988 Apr;14(4):751-9. doi: 10.1016/0360-3016(88)90098-3. |
| 12128109 | Background | Zelefsky MJ, Fuks Z, Hunt M, Yamada Y, Marion C, Ling CC, Amols H, Venkatraman ES, Leibel SA. High-dose intensity modulated radiation therapy for prostate cancer: early toxicity and biochemical outcome in 772 patients. Int J Radiat Oncol Biol Phys. 2002 Aug 1;53(5):1111-6. doi: 10.1016/s0360-3016(02)02857-2. |
| 31399108 | Result | Lacombe J, Brengues M, Mange A, Bourgier C, Gourgou S, Pelegrin A, Ozsahin M, Solassol J, Azria D. Quantitative proteomic analysis reveals AK2 as potential biomarker for late normal tissue radiotoxicity. Radiat Oncol. 2019 Aug 9;14(1):142. doi: 10.1186/s13014-019-1351-8. |
| 26844275 | Result | Azria D, Riou O, Castan F, Nguyen TD, Peignaux K, Lemanski C, Lagrange JL, Kirova Y, Lartigau E, Belkacemi Y, Bourgier C, Rivera S, Noel G, Clippe S, Mornex F, Hennequin C, Kramar A, Gourgou S, Pelegrin A, Fenoglietto P, Ozsahin EM. Radiation-induced CD8 T-lymphocyte Apoptosis as a Predictor of Breast Fibrosis After Radiotherapy: Results of the Prospective Multicenter French Trial. EBioMedicine. 2015 Oct 25;2(12):1965-73. doi: 10.1016/j.ebiom.2015.10.024. eCollection 2015 Dec. |
| 29644007 | Result | Bourgier C, Castan F, Riou O, Nguyen TD, Peignaux K, Lemanski C, Lagrange JL, Kirova Y, Lartigau E, Belkacemi Y, Rivera S, Noel G, Clippe S, Mornex F, Hennequin C, Gourgou S, Brengues M, Fenoglietto P, Ozsahin EM, Azria D. Impact of adjuvant hormonotherapy on radiation-induced breast fibrosis according to the individual radiosensitivity: results of a multicenter prospective French trial. Oncotarget. 2018 Mar 2;9(21):15757-15765. doi: 10.18632/oncotarget.24606. eCollection 2018 Mar 20. |
| 37835370 | Result | Touraine C, Winter A, Castan F, Azria D, Gourgou S. Time-Dependent ROC Curve Analysis for Assessing the Capability of Radiation-Induced CD8 T-Lymphocyte Apoptosis to Predict Late Toxicities after Adjuvant Radiotherapy of Breast Cancer Patients. Cancers (Basel). 2023 Sep 22;15(19):4676. doi: 10.3390/cancers15194676. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |