Clinical trial · Interventional
Radiation Therapy Plus Cisplatin and Gemcitabine in Treating Patients With Cervical Cancer
A Phase I Study of Whole Pelvic Radiation Therapy With Concomitant Cisplatin and Gemcitabine Chemotherapy in Patients With Cervical Carcinoma (Stages I-IV) Limited to the Pelvis
- 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 I trial is studying the side effects and best dose of gemcitabine when given together with radiation therapy and cisplatin in treating patients with cervical cancer that has not spread beyond the pelvis. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining cisplatin with gemcitabine may make the tumor cells more sensitive to radiation therapy and may kill more tumor cells.
Conditions
Conditions (9)
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 Adenocarcinoma | Cervical Adenocarcinoma | CURATED_BROADER | 0.80 |
| Cervical Adenosquamous Carcinoma | Cervical Adenosquamous Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Cervical Small Cell Carcinoma | Cervical Small Cell Neuroendocrine Carcinoma | ALIAS | 0.90 |
| Cervical Squamous Cell Carcinoma | Cervical Squamous Cell Carcinoma | CURATED_BROADER | 0.80 |
| Stage IB Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Cervical Cancer | Malignant Cervical Neoplasm |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine Hydrochloride | Drug | Gemcitabine | ALIAS |
| Internal Radiation Therapy | Radiation | — | UNRESOLVED |
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, and 36 in the absence of disease progression or unacceptable toxicity. Patients also undergo external whole pelvis radiotherapy once daily on days 1-5, 8-13, 15-20, 22-27, and 29-34. After completion of external beam radiotherapy, patients undergo intracavitary radiotherapy and parametrial radiotherapy. The total elapsed time for completion of all radiotherapy is not more than 8 weeks.
- interventionNames
- Drug: Gemcitabine Hydrochloride
- Drug: Cisplatin
- Radiation: Radiation Therapy
- Radiation: Internal Radiation Therapy
Primary outcomes (4)
- measure
- Incidence of acute toxicity using the 21 major categories of the CTEP CTC version 2.0
- timeFrame
- Up to 30 days after completion of radiation therapy
- measure
- Incidence of chronic toxicity using the CTC RTOG/EORTC late radiation morbidity scoring scheme
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed primary invasive carcinoma of the uterine cervix * Previously untreated disease * Any cell type * Stage IB\_2, IIA, IIB, IIIA, IIIB, or IVA * Para-aortic lymph nodes negative by radiologic evaluation or by biopsy if CT scan is suspicious for adenopathy * No known metastases to scalene nodes or other organs outside the radiotherapy field * Study enrollment within 8 weeks of diagnosis * Performance status - GOG 0-2 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Bilirubin no greater than 1.5 times normal * SGOT no greater than 3 times normal * Creatinine less than 2.0 mg/dL * No renal abnormalities (e.g., pelvic kidney, horseshoe kidney, or renal transplantation) that would require modification of radiotherapy fields * No ureteral obstruction allowed unless treated with stent or nephrostomy tube * Not pregnant * Fertile patients must use effective contraception * No septicemia or severe infection * No circumstance that would preclude study completion or follow-up * No other malignancy within the past 5 years except nonmelanoma skin cancer * No prior cytotoxic chemotherapy * No prior pelvic or abdominal radiotherapy * No prior therapy for this malignancy
References
Publications (0)
Data not yet available