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Chemotherapy Followed By Surgery Vs Radiotherapy Plus Chemotherapy in Patients With Stage IB or II Cervical Cancer

NCT00039338 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 686

Last updated 2016-12-05

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed during surgery. Radiation therapy uses high-energy x-rays to kill tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known whether chemotherapy is more effective followed by surgery or combined with radiation therapy in treating cervical cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy followed by radical hysterectomy with that of chemotherapy plus radiation therapy in treating patients who have stage IB or stage II cervical cancer.

Conditions

Interventions

PROCEDURE

conventional surgery

Radial hysterectomy

PROCEDURE

neoadjuvant chemotherapy

Experimental arm: minimal cumulative cisplatin dose of 225 mg/m2. Comparator arm: cumulative cisplatin dose of 200-240 mg/m2.

RADIATION

brachytherapy

Brachytherapy at the end of external radiation. Minimal total dose (external with or without external boost + brachytherapy) of 75 Gy EQD2 to point A. Overall treatment less than 50 days.

RADIATION

radiation therapy

Between 45-50 Gy, in fractions of 1.8 to 2 Gy.

DRUG

cisplatin

Minimal cumulative 225 mg/m2 (experimental arm). Cumulative 200-240 mg/m2 (comparator arm).

Sponsors & Collaborators

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Fabio Landoni, MD · Istituto Europeo Di Oncologia, Milano

  • Alessandro Colombo, MD · Ospedale Alessandro Manzoni, Lecco

  • Stefano Greggi, MD, PhD · Istituto Nazionale per lo Studio e la Cura dei Tumori, Napoli

  • Gemma G. Kenter, MD · Academisch Medisch Centrum - Universiteit van Amsterdam

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-03-31
Primary Completion
2019-07-31

Countries

  • Austria
  • Belgium
  • France
  • Italy
  • Netherlands
  • Portugal
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00039338 on ClinicalTrials.gov