Clinical trial · Observational
Evaluation of an Apoptotic Test for Predicting Late Toxicities After Radiotherapy in Breast and Prostate Cancer Patients
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.
NCT00893035CI-TRIAL-00102533completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of this study is to evaluate the prediction of late toxicity by the radiation induced CD8 T-lymphocyte apoptosis
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Intermediate prognosis prostate cancer
- description
- Intermediate prognosis prostate cancer
- label
- Breast cancer
- description
- conservative treatment and age\<60 Boost irradiation and age\>60
Primary outcomes (1)
- measure
- Late complications
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria for prostate cancer patients: * 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 * 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 Exclusion Criteria for prostate cancer patients: * 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. * 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 Inclusion Criteria for breast cancer patients: * 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 Exclusion Criteria for breast cancer patients: * 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
References
Publications (41)
- BACKGROUNDArriagada 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. PMID 4044337
- BACKGROUNDAzria 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. PMID 15328527
- BACKGROUNDBartelink 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. PMID 11794170
- BACKGROUNDBuchholz 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. PMID 10524402
- BACKGROUNDCesaretti 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. PMID 15629612
- BACKGROUNDCrompton 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. PMID 8989370