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
Bibliographic record
Abstract
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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".