CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 29 enrolled
Drug / intervention
cisplatin +3 moredrug
Likely dose
Paclitaxel and cisplatin administered concomitantly with extended field radiation therapy; specific doses not detailed in the protocol sectionAI-extracted
Key inclusion· 6
  • Histologically proven invasive cervical carcinoma (squamous cell, adenosquamous, or adenocarcinoma)
  • TNM stage IIIB or IVA (FIGO stage IB, IIA, IIB, IIIA, IIIB, or IVA)
  • Cytologically or histologically proven metastases to para-aortic lymph nodes
  • No more than 8 weeks since diagnosis
Key exclusion· 7
  • Prior cytotoxic chemotherapy for this or any other malignancy
  • Prior radiotherapy for this or any other malignancy, including prior pelvic or abdominal radiation
  • Metastases to scalene nodes, intraperitoneal metastases, or metastases to organs outside the radiation field
  • Positive chest CT (evidence of thoracic metastases)

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

Search/NCT00003377
NCT00003377Phase 1Completed

A Phase I Study of Extended Field Radiation Therapy With Concomitant Paclitaxel and Cisplatin Chemotherapy in Patients Cervical Carcinoma Metastatic to the Para-Aortic Lymph Nodes

Gynecologic Oncology Group·interventional·Posted Jan 27, 2003·Updated Feb 4, 2013

In Brief

A Phase 1 clinical trial evaluating cisplatin, paclitaxel, and 2 other interventions for Cervical Cancer. Completed, enrolled 29 participants across 13 sites.

Detailed Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Paclitaxel and cisplatin may increase the effectiveness of radiation therapy by making the tumor cells more sensitive to the radiation. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel when given with radiation therapy and cisplatin and to see how well they work in treating patients with cancer of the cervix that has spread to the lymph nodes in the pelvis and abdomen.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Cancer
CountriesUnited States

Timeline

Phase 1CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartNov 1, 1999
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 9.7 yearsPosted 23.4 years ago

Interventions

cisplatindrug

paclitaxeldrug

brachytherapyradiation

radiation therapyradiation