Clinical trial · Interventional
High Dose Intensity Modulated Radiation Therapy in the Cervical Cancer With Metastatic Lymphadenopathies.
A Phase II Study of High Dose Intensity Modulated Radiation Therapy in the Cervical Cancer With Metastatic Lymphadenopathies at Initial Diagnosis.
NCT01730651CI-TRIAL-00047155unknownN/AClinicalTrials.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)
This phase II study of high dose intensity modulated radiation therapy in the cervical cancer with metastatic lymphadenopathies at initial diagnosis
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tomotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tomotherapy
- description
- 1. Tomotherapy fraction size (Gy) = 0.4 x 진단 당시의 LN short diameter (cm) + 1.6 (pilot study range, 1.5-3.0 Gy) 2. Total dose(summation dose with 3D-CRT) (Gy10) (EQD2, α/β=10 Gy) = 5 x 진단 당시의 LN short diameter (cm) + 56 (pilot study range, 54.6-78.0 Gy)
- interventionNames
- Radiation: Tomotherapy
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- documented data of death, up to 3 years
- description
- From date of initiation of radiotherapy until the date of documented date of death from any cause, assessed up to 3 years
Secondary outcomes (1)
- measure
- Disease-free survival (DFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients (who have been adequately clinically staged) with primary, untreated, histologically confirmed carcinoma of the uterine cervix (including clear cell and small cell carcinoma), with metastatic lymphadenopathies (any of pelvis or PAN \>1.5 cm in short diameter, with/without biopsy proven inguinal lymph node \[ING\]) 2. Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, 2 3. Patients with adequate bone marrow function: absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, platelets greater than or equal to 100,000/mcl at the beginning. 4. Patients with adequate renal function: creatinine equal to or less than 2.0 mg%. 5. Patients who have signed an approved informed consent and authorization Exclusion Criteria: 1. Patients with recurrent LN(s) which was(were) previously irradiated. 2. Patients who have diagnosis of other malignance tumors except papillary or follicular thyroid cancer or skin cancer 3. Patients with metastatic lymphadenopathies other than pelvis, PAN, ING (e.g. supraclavicular or mediastinal metastatic lymphadenopathy) 4. Patients with distant organ metastasis (e.g. bone, lung, brain…)
References
Publications (0)
Data not yet available
No reference posted for this study.