Phase 2
N=45
Radiation Therapy and Cisplatin With or Without Amifostine for Patients With Stage IIIB or IVA Cervical Cancer
Cervical Cancer · Radiation Toxicity
Bottom Line
View on ClinicalTrials.gov: NCT00012012 ↗Enrolled (actual)
45
Serious AEs
78.1%
Results posted
Jan 2015
Primary outcome: Primary: Rate of Acute Grade 3/4 Toxicity (Excluding Grade 3 Leukopenia) — 81 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Amifostine trihydrate (Drug); Cisplatin (Drug); Intracavitary brachytherapy (Radiation); External beam radiation therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Radiation Therapy Oncology Group
- Primary completion
- Sep 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Acute Grade 3/4 Toxicity (Excluding Grade 3 Leukopenia) |
81 | — |
| PRIMARY Number of Patients With Acute Grade 3/4 Toxicity (Excluding Grade 3 Leukopenia) |
13 | — |
| SECONDARY Pelvic Tumor Control |
— | — |
| SECONDARY Distant Metastases |
— | — |
Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Drugs such as amifostine may protect normal cells from the side effects of radiation therapy.
PURPOSE: Phase I/II trial to study the effectiveness of combining cisplatin and radiation therapy with or without amifostine in treating patients who have stage IIIB or stage IVA cancer of the cervix.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically proven, locally advanced carcinoma of the uterine cervix
- TNM classification stage IIIB or IVA
- Disease metastatic to para-aortic or high common iliac lymph nodes
- Prior complete surgical resection of involved lymph nodes or gross residual tumor involvement of a lymph node allowed
- The following cellular types are eligible:
- Squamous cell carcinoma
- Adenocarcinoma
- Adenosquamous carcinoma
- The following cellular types are ineligible:
- Small cell carcinoma
- Carcinoid tumor
- Glassy cell carcinoma
- Clear cell carcinoma
- Cystadenocarcinoma
- No metastatic disease outside of the pelvis (except to the para-aortic nodes)
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-1
Life expectancy
- At least 6 months
Hematopoietic
- White blood cell count (WBC) at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.5 mg/dL
- Alanine amino transferase (ALT) no greater than 2 times normal
Renal
- Creatinine no greater than 1.5 mg/dL (urinary diversion allowed)
- Corrected calcium normal
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No concurrent significant medical condition that would preclude study participation
- No insulin-dependent diabetes
- No other malignancy within the past 3 years except cutaneous basal cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior systemic chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No prior pelvic irradiation except transvaginal radiotherapy to control bleeding
Surgery
- See Disease Characteristics
- No prior tumor-directed surgery except lymph node biopsy/staging
Data sourced from ClinicalTrials.gov (NCT00012012). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.