Clinical trial · Interventional
Carboplatin, Docetaxel, and Radiation Therapy in Treating Patients With Stage III/IV, or Recurrent Endometrial Cancer
A Phase II Trial of Induction Carboplatin and Docetaxel Followed by Radiotherapy Then Consolidation Chemotherapy With Carboplatin and Docetaxel in Stage III, IV and Recurrent Endometrial 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)
RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving carboplatin and docetaxel followed by radiation therapy works in treating patients with stage III, stage IV, or recurrent endometrial cancer.
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 |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with Endometrial Cancer
- description
- Patients with advanced or current endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (Weekly, 5 days/week over 6-7 weeks, tailored 4500 cGy) and followed by 3 courses of consolidation docetaxel (75 mg/m\^2 on Day 1 of each course) /carboplatin (Dose = Area-under-the-curve 6 on Day 1 every 3 weeks for 3 cycles).
- interventionNames
- Drug: carboplatin
- Drug: docetaxel
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Percent of Patients Estimated to be Progression-Free and Alive
- timeFrame
- 1 Year, 2 Years, 3 Years
- description
- This estimate was determined by using a statistical method of analysis (Kaplan-Meier).
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically confirmed endometrial cancer
* Advanced or recurrent disease
* Stage IIIB or IIIC disease
* Stage IIIA disease allowed provided there is serosal involvement or direct extension or metastasis to the adnexa
* No stage IIIA confirmed by only positive peritoneal washings
* Stage IVA or IVB disease
* Failed local therapy or considered incurable with local therapy
* Measurable or evaluable disease
* Not required for newly diagnosed stage III or IV disease with no remaining disease after surgery
* Performance status Gynecology Oncology Group (GOG) 0-1
* Life expectancy at least 12 weeks
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 10 g/dL
* Meets 1 of the following criteria:
* Alkaline phosphatase (AP) normal AND aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 5 times upper limit of normal (ULN)
* AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
* AP ≤ 5 times ULN AND AST or ALT normal
* Bilirubin normal
* No acute hepatitis
* Creatinine ≤ 1.5 mg/dL
Exclusion Criteria:
* Known hypersensitivity to docetaxel or polysorbate 80
* Severe infection
* Septicemia
* Pregnant or nursing
* Positive pregnancy test
* Fertile patients must use effective nonhormonal contraception during and for at least 3 months after study treatment
* Peripheral neuropathy ≥ grade 2
* Severe gastrointestinal bleeding requiring a blood transfusion or hospitalization
* Other malignancy within the past 5 years except nonmetastatic, nonmelanoma skin cancer or carcinoma in situ of the cervix
* Prior chemotherapy
* Prior radiotherapyReferences
Publications (0)
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