At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 45 enrolled

Drug / intervention

Amifostine trihydrate +3 moredrug

Likely dose

Cisplatin 40 mg/m² IV weekly × 6 doses (with external beam radiation and once with brachytherapy); Amifostine 500 mg subcutaneous before each radiation treatmentAI-extracted

Key inclusion· 7

✓Histologically confirmed locally advanced cervical cancer (TNM IIIB or IVA) with disease metastatic to para-aortic or high common iliac lymph nodes
✓Squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma histology
✓Age 18 and over
✓Zubrod performance status 0–1

Key exclusion· 6

✕Small cell carcinoma, carcinoid tumor, glassy cell carcinoma, clear cell carcinoma, or cystadenocarcinoma histology
✕Metastatic disease outside the pelvis (except para-aortic nodes)
✕Prior pelvic irradiation (except transvaginal radiotherapy to control bleeding)
✕Insulin-dependent diabetes

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00012012

NCT00012012Phase 2Completed

Compare CT.gov

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

Radiation Therapy Oncology Group·interventional·Posted Jan 27, 2003·Updated Jan 7, 2015

In Brief

A Phase 2 clinical trial evaluating Amifostine trihydrate, Cisplatin, and 2 other interventions for Cervical Cancer and Radiation Toxicity. Completed, enrolled 45 participants across 17 sites.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsCervical Cancer, Radiation Toxicity

CountriesUnited States

CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished

200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartAug 2001

First PostedJan 2003

Primary CompletionSep 2007

Study CompletionJun 2010

TodayJul 2026

First PostedJan 27, 2003

Enrollment StartAug 1, 2001

Primary CompletionSep 1, 2007

Study CompletionJun 1, 2010

TodayJul 2, 2026

Enrollment to primary: 6.1 yearsPosted 23.4 years ago

Interventions

Amifostine trihydratedrug

Amifostine will be delivered before each radiation treatment. Amifostine (500 mg) will be given as two equally-divided subcutaneous injections.

Cisplatindrug

Cisplatin will be given weekly with external beam radiation therapy and once with brachytherapy for a total of six doses. Patients receive 40 mg/m\^2 by IV over 30-60 minutes on days 1, 8, 15, 22, 29, and 36.

Intracavitary brachytherapyradiation

For low dose rate (LDR) brachytherapy, cesium will be given in one to two intracavitary applications, within two weeks of completion of external radiation. The interval between the two applications will be one to three weeks. It is recommended that the total course of treatment be completed in less than eight weeks. High dose rate (HDR) brachytherapy may start as early as week two of external radiation. The minimum cumulative external and intracavitary dose should be 85 Gy.

External beam radiation therapyradiation

Patients will receive 1.8 Gy daily for five weeks for a total dose of 45 Gy; involved lateral parametrium and/or pelvic nodes should be boosted for a total dose (including intracavitary treatment) of 60 Gy ± 5%.