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

NCT00039338 | Unknown Phase 3 DMC

• 2 other identifiers: EORTC-559942008-003396-52
• Study Type: interventional
• Target: 686
• Locations: 8 countries
• Sites: 24

Brief 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

Cervical Cancer

Keywords

stage IB cervical cancer; stage IIB cervical cancer; stage IIA cervical cancer; cervical squamous cell carcinoma; cervical adenocarcinoma; cervical adenosquamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall survival at 5 years

  5 years

Study Arms (2)

Chemotherapy followed by surgery

EXPERIMENTAL

neoadjuvant chemotherapy (Cisplatin) followed by surgery (radial hysterectomy)

Procedure: conventional surgery; Procedure: neoadjuvant chemotherapy; Drug: cisplatin

Radio-chemotherapy

ACTIVE COMPARATOR

Concomitant radiotherapy (external radiotherapy combined with external boost or brachytherapy) and chemotherapy (cisplatin)

Procedure: neoadjuvant chemotherapy; Radiation: brachytherapy; Radiation: radiation therapy; Drug: cisplatin

Interventions

conventional surgery PROCEDURE

Radial hysterectomy

Chemotherapy followed by surgery

neoadjuvant chemotherapy PROCEDURE

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

Chemotherapy followed by surgery; Radio-chemotherapy

brachytherapy RADIATION

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.

Radio-chemotherapy

radiation therapy RADIATION

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

Radio-chemotherapy

cisplatin DRUG

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

Chemotherapy followed by surgery; Radio-chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed cervical cancer, including the following subtypes: * Squamous cell carcinoma * Adenosquamous cell carcinoma * Adenocarcinoma (excluding small cell, clear cell, and other rare variants of the classical adenocarcinoma) * FIGO stage IB2, IIA (greater than 4 cm), or IIB PATIENT CHARACTERISTICS: Age: * 18 to 75 Performance status: * WHO 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count greater than 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * Bilirubin less than 1.46 mg/dL Renal: * Creatinine clearance greater than 60 mL/min Other: * No other prior or concurrent malignancy except adequately treated basal cell skin cancer * No psychological, familial, sociological, or geographical condition that would preclude study * Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy Surgery: * Not specified Other: * No other concurrent anticancer agent

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (24)

Karl-Franzens-University Graz

Graz, Austria

Location

Kaiser Franz Josef Hospital

Vienna, Austria

Location

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

Location

U.Z. Gasthuisberg

Leuven, Belgium

Location

Centre Hospitalier Regional de la Citadelle

Liège, 4000, Belgium

Location

Centre Regional Francois Baclesse

Caen, France

Location

Istituto Europeo Di Oncologia

Milan, Italy

Location

Ospedale San Gerardo

Monza, Italy

Location

Istituto Nazionale Per Lo Studio E La Cura Dei Tumori

Naples, Italy

Location

Ospedale Mauriziano Umberto I

Torino, 10128, Italy

Location

Clinica Universitaria

Turin, 10126, Italy

Location

Ospedale di Circolo e Fondazione Macchi

Varese, Italy

Location

Academisch Medisch Centrum at University of Amsterdam

Amsterdam, 1105 AZ, Netherlands

Location

Vrije Universiteit Medisch Centrum

Amsterdam, Netherlands

Location

Medisch Spectrum Twente

Enschede, Netherlands

Location

Leiden University Medical Center

Leiden, Netherlands

Location

Universitair Medisch Centrum St. Radboud - Nijmegen

Nijmegen, Netherlands

Location

Erasmus MC - Daniel den Hoed Cancer Center

Rotterdam, 3008 AE, Netherlands

Location

Universitair Medisch Centrum - Academisch Ziekenhuis

Utrecht, Netherlands

Location

Hospitais da Universidade de Coimbra (HUC)

Coimbra, Portugal

Location

Hospital Universitario San Carlos

Madrid, Spain

Location

Queen Elizabeth The Queen Mother Hospital

Margate, England, United Kingdom

Location

NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre

Glasgow, Scotland, United Kingdom

Location

Mid Kent Oncology Centre

Maidstone, Kent, United Kingdom

Location

Related Publications (1)

• Kenter GG, Greggi S, Vergote I, Katsaros D, Kobierski J, van Doorn H, Landoni F, van der Velden J, Reed N, Coens C, van Luijk I, Colombo N, Steen-Banasik EV, Ottevanger N, Casado A; EORTC-55994 Study Group. Randomized Phase III Study Comparing Neoadjuvant Chemotherapy Followed by Surgery Versus Chemoradiation in Stage IB2-IIB Cervical Cancer: EORTC-55994. J Clin Oncol. 2023 Nov 10;41(32):5035-5043. doi: 10.1200/JCO.22.02852. Epub 2023 Sep 1.

  PMID: 37656948 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Neoadjuvant Therapy; Brachytherapy; Radiotherapy; Cisplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Fabio Landoni, MD

  Istituto Europeo Di Oncologia, Milano

  STUDY CHAIR

• Alessandro Colombo, MD

  Ospedale Alessandro Manzoni, Lecco

  STUDY CHAIR

• Stefano Greggi, MD, PhD

  Istituto Nazionale per lo Studio e la Cura dei Tumori, Napoli

  STUDY CHAIR

• Gemma G. Kenter, MD

  Academisch Medisch Centrum - Universiteit van Amsterdam

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2002
• First Posted: January 27, 2003
• Study Start: March 1, 2002
• Primary Completion: July 1, 2019
• Last Updated: December 5, 2016

Record last verified: 2016-12

Locations

GB (3); BE (3); ES (1); AU (2); IT (6); FR (1); NL (7); PT (1)