Clinical trial · Interventional
Radiation Therapy and Cisplatin With or Without Amifostine for Patients With Stage IIIB or IVA Cervical Cancer
A Two Part Phase I/II Study Of Extended Field External Irradiation And Intracavitary Brachytherapy Combined With Chemotherapy And Amifostine In Carcinoma Of The Cervix With Positive Para-Aortic Or High Common Iliac Lymph Nodes
NCT00012012CI-TRIAL-00016535completedPhase 1 / Phase 2Results postedClinicalTrials.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)
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.
Conditions
Conditions (2)
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 Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Radiation Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Amifostine trihydrate | Drug | — | UNRESOLVED |
| Cisplatin | Drug | Cisplatin | ALIAS |
| External beam radiation therapy | Radiation | — | UNRESOLVED |
| Intracavitary brachytherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Radiation therapy plus cisplatin
- description
- Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin.
- interventionNames
- Drug: Cisplatin
- Radiation: Intracavitary brachytherapy
- Radiation: External beam radiation therapy
- type
- EXPERIMENTAL
- label
- Radiation therapy plus cisplatin and amifostine
- description
- Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin and amifostine trihydrate.
- interventionNames
- Drug: Amifostine trihydrate
- Drug: Cisplatin
- Radiation: Intracavitary brachytherapy
- Radiation: External beam radiation therapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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/stagingReferences
Publications (3)
- BACKGROUNDViswanathan AN, Moughan J, Small W Jr, Levenback C, Iyer R, Hymes S, Dicker AP, Miller B, Erickson B, Gaffney DK. The quality of cervical cancer brachytherapy implantation and the impact on local recurrence and disease-free survival in radiation therapy oncology group prospective trials 0116 and 0128. Int J Gynecol Cancer. 2012 Jan;22(1):123-31. doi: 10.1097/IGC.0b013e31823ae3c9. PMID 22193645
- RESULTSmall W Jr, Winter K, Levenback C, Iyer R, Hymes SR, Jhingran A, Gaffney D, Erickson B, Greven K. Extended-field irradiation and intracavitary brachytherapy combined with cisplatin and amifostine for cervical cancer with positive para-aortic or high common iliac lymph nodes: results of arm II of Radiation Therapy Oncology Group (RTOG) 0116. Int J Gynecol Cancer. 2011 Oct;21(7):1266-75. doi: 10.1097/IGC.0b013e31822c2769. PMID 21892091
- RESULTSmall W Jr, Winter K, Levenback C, Iyer R, Gaffney D, Asbell S, Erickson B, Jhingran A, Greven K. Extended-field irradiation and intracavitary brachytherapy combined with cisplatin chemotherapy for cervical cancer with positive para-aortic or high common iliac lymph nodes: results of ARM 1 of RTOG 0116. Int J Radiat Oncol Biol Phys. 2007 Jul 15;68(4):1081-7. doi: 10.1016/j.ijrobp.2007.01.026. Epub 2007 Mar 29. PMID 17398031