Phase II study of radiation therapy combined with weekly nedaplatin in locally advanced uterine cervical carcinoma: Kitasato Gynecologic Radiation Oncology Group (KGROG 0501) - an initial analysis
Notice bibliographique
Résumé
5057 Background: Locally advanced uterine cervical carcinoma (LAUCC) treated with chemoradiotherpaty is considered to be the standard treatment regimen. However, no evidence of its efficacy and safety has been obtained from a Japanese population. Futhermore, The total dose of Japanese radiation therapy protocol is lesser than that of US and Canada, which indicated that chemoradciotherapy for LAUCC is better than radiation therapy alone by phase III clinical trials. Thus, the current phase II study was designed to evaluate chemoradiotherapy with lesser radiation dose for LAUCC using weekly nedaplatin to be effective and safety in a Japanese population. Nedaplatin is a platitum drug and is required to no hydration to infuse patients because less toxic to renal function,which was produced by Shionogi Pharmaceutical Co., Japan. If this phase II trial success, chemoradiotherapy for LAUACC in out-patient clinic could be possible. Patients and Methods: :Patients registered in the current study are found to have LAUCC including following criteria i) pathological proven of squamous cell carcinoma or adenocarcinom, ii) clinical stage according to FIGO is Ib, IIa, IIb with bulky tumor (diameter: 40 > mm assessed by pelive magnetic resonace imaging) or pelvic lymph node swelling (diameter: >10mm assessed by pelvic computed tomography), ) iii) clinical stage IIIa, IIIb and IVa according to FIGO with no para-aortic lymph node swelling (diameter: > 10 mm) observed by abdominal computed tomography. iv) Age: 20-75 years. v) perfomance Status: 0-2. Treatement Protocol is as follows. Radiation therapy is a combination of external beam radiation therapy (total dose: 50 Gy-52 Gy /25-27 fractions with central shielding after 30-32 Gy) with high-dose rate intracavitary irradiation (24-30 Gy/4-6 fractions to point A). Chemothrapy applied in the current study is weekly nedaplatin infused by intravenous (30 mg/mm2/time, once a week, total 150mg/mm2/5weeks) Sample size in the current study is 45 LAUCC patients recruiting for 3-years at a single institution. This protocol was permitted by ethics committee at Kitasato University Hospital. Results: Ten patients were registered in this study between June 2005 and March 2006. The median age was 57.5 years (range; 36-73). PS0 was 5 and PS1 was 5. As for Clinical stage, 9 was IIIb and the only one was IIb. 9 patients have benn proven to be squamous cell carcinoma and the one to be adenocarcinoma. The median maximum tumor diameter was 62.5 mm (range; 30 - 100 mm). As for Initial response, 8 was CRs and 2 was PRs (100% of response rate). As for hematological acute morbidity, 3 was grade 3, 6 was grade 6, 1 was grade 4. Conclusions:This initial analysis of phase II study confirmed that concurrent chemoradiotherapy using nedaplatin was safe and efficacy and we decided to undergo the further study.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,002 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,001 |
| Méta-épidémiologie (sens large) | 0,002 | 0,002 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,001 | 0,001 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,001 | 0,000 |
| Intégrité de la recherche | 0,001 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,003 | 0,001 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».