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Cervical CancerPhase 1NCT00137358

Radiation With Chemotherapy and a Study Drug to the Para-Aortic Nodes in Cervical Cancer

A Phase 1 study testing Radiation Therapy, Cisplatin and Amifostine in people with Cervical Cancer, run by University of Alabama at Birmingham at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Investigator has since decided not to pursue this protocol further. No patients were enrolled. This study is to determine the maximum tolerated dose of external beam radiation to the para-aortic lymph nodes using intensity modulated radiation therapy (IMRT). Read more about this study

Who is it for?
Ages 19 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Cervical Cancer
What is being tested?
Radiation Therapy, Cisplatin and Amifostine
Type of treatment
Surgery or procedure
How many people
0 participants
Where
1 siteUnited States
Study dates
Start not givento not given
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • No prior therapy other than biopsy of the cervix or endoscopic pelvic nodal resection.
  • Patients may have endoscopic resection of enlarged pelvic and low common iliac nodes, however, needle biopsy only of enlarged para-aortic nodes will be eligible for entry.
  • Patients with squamous cell, adenocarcinoma, and adenosquamous carcinoma are eligible.
  • Patients must have no evidence of metastatic disease outside of the pelvis (except to the para-aortic nodes).
  • Patients must have Zubrod performance status 0-1 and no medical contraindications to the administration of full dose chemotherapy.
  • Patients must have a life expectancy > 6 months
  • Adequate bone marrow function: white blood cell (WBC) 3000/mm3 (absolute neutrophil count [ANC] 1500/mm3); adequate renal function: creatinine 1.5 mg/dl (urinary diversion is permitted to improve renal function); patients must have bilirubin 1.5 mg/dl, ALT 2 x normal.
  • No prior (within last 3 years) or simultaneous malignancies (other than basal cell or non-invasive tumors)

Who cannot join

  • Complete resection of the involved para-aortic nodes.
  • Patients with evidence of bowel adherent to the GTV by contrast enhanced computed tomography (CT) scan will be ineligible.
  • Patients with the following histologies will be ineligible: glassy cell, small cell, carcinoid, adenoid cystic, and clear cell.
  • Prior (within last 3 years) malignancies other than basal cell carcinoma or non-invasive malignancies.
  • Prior chemotherapy.
  • Prior pelvic or abdominal radiation (other than transvaginal irradiation to control bleeding).
Show all 13Show fewer
  • Prior tumor-directed surgery other than lymph node sampling/staging
  • Life expectancy < 6 months
  • Patients who are pregnant will be ineligible.
  • Patients with insulin dependent diabetes will be ineligible.
  • Patients who are obese, such that reliable immobilization is not achieved.
  • Patients with pain or discomfort that would preclude lying still for extended periods of time.
  • Patients with tumors that are bleeding and require more immediate treatment.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

Other trials in United States

About this study

Official title: Phase I Trial of Dose Escalated IMRT to the Para-aortic Nodes With Concurrent Cisplatin and Amifostine in Locally Advanced Cervical Cancer

Investigator has since decided not to pursue this protocol further. No patients were enrolled.

This study is to determine the maximum tolerated dose of external beam radiation to the para-aortic lymph nodes using intensity modulated radiation therapy (IMRT).

This protocol will test the hypothesis that the use of IMRT and amifostine will decrease GI toxicity and therefore allow the radiation dose to the para-aortic lymph nodes to be safely escalated.

Read the detailed description

This is a Phase I open-label multi-institutional study that will enroll a minimum of 27 and up to 42 patients with locally advanced cervical cancer (a minimum of 27 will be entered if all dose levels are explored without reaching a dose limiting toxicity at any level). The primary objective is to determine the maximum tolerated dose (MTD) of external beam radiation to the para-aortic lymph nodes using IMRT and amifostine. Patients will be stratified according to gross tumor volume (GTV) prior to dose escalation.

Within each GTV stratum, the dose escalation will be determined as follows: Accrue 3 patients in the first dose level based on the determined stratum. A Dose Limiting Toxicity is defined as the development of > Grade 3 acute GI toxicity, per the RTOG acute toxicity scale. If no DLT is observed at the first dose level, 3 patients will be enrolled at the next dose level. If one patient experiences DLT at a given dose level, 3 additional patients will be enrolled at that dose level. If 0 of these 3 additional patients experience DLT, dosing of the next dose level is begun. If 1 or more of these 3 additional patients experience DLT at the highest dose level below the maximally administered dose, this dose becomes the recommended dose. At least 6 patients must be entered at this recommended dose. The Maximum Tolerated Dose (MTD) is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.

Conditions
Cervical Cancer
Being tested
Radiation Therapy, Cisplatin, Amifostine
Keywords
Cervical, Uterine, Para-aortic, Nodes, IMRT, Cancer
Medical subject headings
Uterine Cervical Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiation TherapyProcedure or surgery

  • CisplatinDrug

  • AmifostineDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary objective is to determine the maximum tolerated dose (MTD) of external beam radiation to the para-aortic lymph nodes using IMRT and amifostine.

Secondary outcomes (1)

  1. The secondary endpoints include local-regional control, overall survival and toxicity.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2005 (estimated)

Why it stopped: unable to obtain funding to conduct study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00137358
Sponsor's protocol ID
ETH175-04D
Status last verified
Jan 2013
First submitted
26 Aug 2005
Last updated
24 Jan 2013
Results posted
No

Publications

  • Grigsby PW, Heydon K, Mutch DG, Kim RY, Eifel P. Long-term follow-up of RTOG 92-10: cervical cancer with positive para-aortic lymph nodes. Int J Radiat Oncol Biol Phys. 2001 Nov 15;51(4):982-7. doi: 10.1016/s0360-3016(01)01723-0.

    PubMed 11704321

  • Berman ML, Keys H, Creasman W, DiSaia P, Bundy B, Blessing J. Survival and patterns of recurrence in cervical cancer metastatic to periaortic lymph nodes (a Gynecologic Oncology Group study). Gynecol Oncol. 1984 Sep;19(1):8-16. doi: 10.1016/0090-8258(84)90151-3.

    PubMed 6469092

  • Lepanto P, Littman P, Mikuta J, Davis L, Celebre J. Treatment of para-aortic nodes in carcinoma of the cervix. Cancer. 1975 Jun;35(6):1510-3. doi: 10.1002/1097-0142(197506)35:63.0.co;2-u.

    PubMed 807311

  • Lovecchio JL, Averette HE, Donato D, Bell J. 5-year survival of patients with periaortic nodal metastases in clinical stage IB and IIA cervical carcinoma. Gynecol Oncol. 1989 Jul;34(1):43-5. doi: 10.1016/0090-8258(89)90103-0.

    PubMed 2737524

  • Nori D, Valentine E, Hilaris BS. The role of paraaortic node irradiation in the treatment of cancer of the cervix. Int J Radiat Oncol Biol Phys. 1985 Aug;11(8):1469-73. doi: 10.1016/0360-3016(85)90334-7.

    PubMed 4019270

  • Tewfik HH, Buchsbaum HJ, Latourette HB, Lifshitz SG, Tewfik FA. Para-aortic lymph node irradiation in carcinoma of the cervix after exploratory laparotomy and biopsy-proven positive aortic nodes. Int J Radiat Oncol Biol Phys. 1982 Jan;8(1):13-8. doi: 10.1016/0360-3016(82)90378-9.

    PubMed 7061247

  • Grigsby PW, Perez CA, Chao KS, Herzog T, Mutch DG, Rader J. Radiation therapy for carcinoma of the cervix with biopsy-proven positive para-aortic lymph nodes. Int J Radiat Oncol Biol Phys. 2001 Mar 1;49(3):733-8. doi: 10.1016/s0360-3016(00)00806-3.

    PubMed 11172956

  • Rubin SC, Brookland R, Mikuta JJ, Mangan C, Sutton G, Danoff B. Para-aortic nodal metastases in early cervical carcinoma: long-term survival following extended-field radiotherapy. Gynecol Oncol. 1984 Jun;18(2):213-7. doi: 10.1016/0090-8258(84)90028-3.

    PubMed 6735264

  • Carl UM, Bahnsen J, Wiegel T. Radiation therapy of para-aortic lymph nodes in cancer of the uterine cervix. Acta Oncol. 1993;32(1):63-7. doi: 10.3109/02841869309083887.

    PubMed 8466766

  • Varia MA, Bundy BN, Deppe G, Mannel R, Averette HE, Rose PG, Connelly P. Cervical carcinoma metastatic to para-aortic nodes: extended field radiation therapy with concomitant 5-fluorouracil and cisplatin chemotherapy: a Gynecologic Oncology Group study. Int J Radiat Oncol Biol Phys. 1998 Dec 1;42(5):1015-23. doi: 10.1016/s0360-3016(98)00267-3.

    PubMed 9869224

  • Podczaski E, Stryker JA, Kaminski P, Ndubisi B, Larson J, DeGeest K, Sorosky J, Mortel R. Extended-field radiation therapy for carcinoma of the cervix. Cancer. 1990 Jul 15;66(2):251-8. doi: 10.1002/1097-0142(19900715)66:23.0.co;2-e.

    PubMed 2369710

  • Malfetano JH, Keys H. Aggressive multimodality treatment for cervical cancer with paraaortic lymph node metastases. Gynecol Oncol. 1991 Jul;42(1):44-7. doi: 10.1016/0090-8258(91)90228-w.

    PubMed 1916509

  • Mutic S, Malyapa RS, Grigsby PW, Dehdashti F, Miller TR, Zoberi I, Bosch WR, Esthappan J, Low DA. PET-guided IMRT for cervical carcinoma with positive para-aortic lymph nodes-a dose-escalation treatment planning study. Int J Radiat Oncol Biol Phys. 2003 Jan 1;55(1):28-35. doi: 10.1016/s0360-3016(02)03804-x.

    PubMed 12504033

  • Aoki T, Nagata Y, Mizowaki T, Kokubo M, Negoro Y, Takayama K, Mitsumori M, Sasai K, Hiraoka M. Clinical evaluation of dynamic arc conformal radiotherapy for paraaortic lymph node metastasis. Radiother Oncol. 2003 Apr;67(1):113-8. doi: 10.1016/s0167-8140(02)00388-2.

    PubMed 12758247

  • Wadler S, Goldberg G, Fields A, Anderson P, Beitler JJ, Sood B, Haynes H, Runowicz C. The potential role of amifostine in conjunction with cisplatin in the treatment of locally advanced carcinoma of the cervix. Semin Oncol. 1996 Aug;23(4 Suppl 8):64-8.

    PubMed 8783670

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Radiation Therapy, Cisplatin and Amifostine in people with Cervical Cancer, run by University of Alabama at Birmingham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary objective is to determine the maximum tolerated dose (MTD) of external beam radiation to the para-aortic lymph nodes using IMRT and amifostine.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00137358, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2013.

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