Clinical trial · Interventional
Chemotherapy and Pelvic Hypofractionated Radiation Followed by Surgery Cervical Cancer
Phase II Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy With Standard Fractionated Compared to Hypofractionated Followed by Surgery for Patients With Locally Advanced Cervical Cancer.
NCT03750539CI-TRIAL-00071318unknownN/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)
The purpose of the study is to evaluate the role of hypofractionated in the treatment of locally advanced cervical cancer. The study will be conducted in Honduras and Mexico, and patients will be randomized to a standard fraction (45 Gy in 25 fractions) or hypofractionated (37.5Gy in 15 fractions) followed by surgery. Patients will receive weekly cisplatin with their treatments at 40 mg/m2. Response rate, survival, and toxicity will be evaluated.
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 |
|---|---|---|---|
| Cervix Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hypofractionated radiotherapy | Radiation | — | UNRESOLVED |
| Radical hysterectomy | Procedure | — | UNRESOLVED |
| Standard radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard Treatment
- description
- External Beam pelvic radiation therapy daily dose of 1.8-2 Gray (Gy) per session for 25 sessions to accomplish 45 Gy Chemotherapy ( cisplatin 40mg/m2), intravenous administration of chemotherapy once a week in an hour infusion Type II or type III open radical hysterectomy after 4-6 weeks after completion of external beam radiation
- interventionNames
- Radiation: Standard radiotherapy
- Procedure: Radical hysterectomy
- type
- EXPERIMENTAL
- label
- hypofractionated treatment
- description
- External Beam pelvic radiation therapy daily dose of 1.8-2gy per session for 15 sessions to accomplish 37.5 Gy Chemotherapy ( cisplatin 40mg/m2), intravenous administration of chemotherapy once a week in an hour infusion Type II or type III open radical hysterectomy after 4-6 weeks after completion of external beam radiation
- interventionNames
- Radiation: hypofractionated radiotherapy
- Procedure: Radical hysterectomy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have International Federation of Gynecology and Obstetrics (FIGO) stage IB2-IIB squamous, adenosquamous or adenocarcinoma of cervical with no disease outside of the pelvis by via ultrasound. * No distant metastasis via chest X-ray. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Age 18 * complete blood count (CBC)/differential obtained 14 days before study entry with adequate bone marrow function defined as follows: * Absolute neutrophil count (ANC) ≥ 1,500 cells/mim3 * Platelets 100,000 cells/mim3 * Hemoglobin 8.0 g/dl * White blood count 4000 cell/m3 * An adequate renal function defined as follows: * Serum creatinine 1.5 mg/dl within 14 days before study entry * Patients with known HIV positive must have a cluster of differentiation 4 (CD4) T lymphocytes count be 350 cells/mm3 within 14 days prior to study entry (note, however, that HIV testing is not required for entry into this protocol). Excluding HIV positive patients with invasive cervical cancer and low CD4 cell counts is necessary because the treatments involved in this protocol may be significantly immunosuppressive. * Chest x-ray and ultrasound must be performed within 12 (8 or 12) weeks before the study enrollment (I took out the ct scan of abdomen and pelvis) * Patient must provide study-specific informed consent before study entry. Exclusion Criteria: * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the breast or oral cavity. * Patients cannot have any neuroendocrine histology in pathology. * Prior systemic chemotherapy for the current cervical cancer, note that prior chemotherapy for a different cancer is allowable. * Prior radiation therapy to the pelvis that would result in overlap of radiation therapy fields. * Severe active co-morbidity, defined as follows: * Unstable angina or congestive heart failure requiring hospitalization within the last six months. * Transmural myocardial infarction within the previous six months. * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of the study entry. * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study entry. * Coagulation defects; note, however, that coagulation parameter are not required for entry into this protocol. * Prior allergic reaction to cisplatin or other platinum drugs. * Patients with para-aortic nodes or distant metastasis.
References
Publications (0)
Data not yet available
No reference posted for this study.