Clinical trial · Interventional
Radiation Therapy to the Abdomen Plus Docetaxel in Treating Patients With Recurrent or Persistent Advanced Ovarian, Peritoneal, or Fallopian Tube Cancer
A Phase I Study Using Low Dose Abdominal Radiotherapy as A Docetaxel Chemosensitizer for Recurrent , Persistent Or Advanced Ovarian, Peritoneal Or Fallopian Tube Cancer
- 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)
Phase I trial to study the effectiveness of low-dose radiation therapy to the abdomen combined with docetaxel in treating patients who have recurrent or persistent advanced ovarian, peritoneal, or fallopian tube cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Carcinoma | Fallopian Tube Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Primary Peritoneal Carcinoma | Primary Peritoneal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Ovarian Carcinoma | Ovarian Carcinoma | CURATED_BROADER | 0.78 |
| Stage III Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3-Dimensional Conformal Radiation Therapy | Radiation | — | UNRESOLVED |
| Chemosensitization/Potentiation Therapy | Drug | — | UNRESOLVED |
| Docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (chemosensitization, radiation, docetaxel)
- description
- Patients receive docetaxel IV over 30 minutes once daily on days 1, 8, 15, 22, 29, and 35. Within 3 hours after beginning docetaxel, patients also receive low-dose abdominal radiotherapy twice daily (at least 4 hours apart) on days 1, 2, 8, 9, 15, 16, 22, 24, 29, 30, 35, and 36. Treatment continues in the absence of unacceptable toxicity.
- interventionNames
- Radiation: 3-Dimensional Conformal Radiation Therapy
- Drug: Chemosensitization/Potentiation Therapy
- Drug: Docetaxel
Primary outcomes (1)
- measure
- Incidence of acute toxicity, graded using Common Toxicity Criteria version 2.0
- timeFrame
- Up to 30 days after completion of radiation therapy
Secondary outcomes (1)
- measure
- Incidence of patients with chronic toxicity assessed by Common Toxicity Criteria version 2.0 Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer (CTC v2.0 RTOG/EORTC) late radiation morbidity scoring
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of ovarian, peritoneal, or fallopian tube carcinoma * Radiographic, clinical, or pathologic evidence of relapse * Recurrent or persistent disease after chemotherapy (may be enrolled at first or subsequent relapse) * Received prior taxane OR platinum agent * Performance status - GOG 0-1 * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT/SGPT no greater than 2.5 times ULN * Alkaline phosphatase no greater than 2.5 times ULN * Creatinine no greater than 1.5 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No grade 2 or greater neuropathy (sensory or motor) * No septicemia * No severe infection * No circumstance that would preclude study completion * No prior radiotherapy to the abdomen or pelvis * Patients with ureteral obstruction must undergo stent or nephrostomy tube replacement prior to study entry
References
Publications (0)
Data not yet available