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

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ClinicalTrials.gov Identifier: NCT00039338
Recruitment Status : Unknown
Verified December 2016 by European Organisation for Research and Treatment of Cancer - EORTC.
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : December 5, 2016
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Study Description
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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.


Condition or disease Intervention/treatment Phase
Cervical Cancer Procedure: conventional surgery Procedure: neoadjuvant chemotherapy Radiation: brachytherapy Radiation: radiation therapy Drug: cisplatin Phase 3

Detailed Description:

OBJECTIVES:

  • Compare the overall and progression-free survival of patients with stage IB2, IIA, or IIB cervical cancer treated with neoadjuvant cisplatin-based chemotherapy followed by radical hysterectomy vs standard therapy comprising concurrent radiotherapy and cisplatin-based chemotherapy.
  • Compare the toxicity of these regimens in these patients.
  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, FIGO stage, age (18 to 50 vs 51 to 75), and histological subtype (adenomatous vs non-adenomatous component). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive neoadjuvant cisplatin-based chemotherapy on day 1. Treatment repeats every 21 days. Within 6 weeks after the last chemotherapy course, patients undergo a type III-V Piver-Rutledge radical hysterectomy. Patients with positive lymph nodes or tumor invasion into the parametria or less than 5 mm from the resection borders after surgery receive standard adjuvant external beam radiotherapy once daily, 5 days a week, for 5-5.6 weeks (25-28 treatment days) followed by external boost radiotherapy or brachytherapy for 1 or 2 days.
  • Arm II: Patients receive standard therapy comprising radiotherapy as in arm I concurrently with cisplatin-based chemotherapy once weekly for 6 weeks. Adjuvant hysterectomy is allowed, but not recommended, in case of histologically proven residual tumor.

Treatment in both arms continues in the absence of disease progression or unacceptable toxicity. For patients in both arms, cisplatin may be combined with other chemotherapeutics as long as the minimum platinum dose is given.

Quality of life is assessed at baseline and at 6, 12, 18, and 24 months.

Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 686 patients (343 per treatment arm) will be accrued for this study within 3.8 years.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 686 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase III Study Of Neoadjuvant Chemotherapy Followed By Surgery Vs. Concomitant Radiotherapy And Chemotherapy In FIGO Ib2, IIa>4 cm or IIb Cervical Cancer
Study Start Date : March 2002
Estimated Primary Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Chemotherapy followed by surgery
neoadjuvant chemotherapy (Cisplatin) followed by surgery (radial hysterectomy)
 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.

Drug: cisplatin
Minimal cumulative 225 mg/m2 (experimental arm). Cumulative 200-240 mg/m2 (comparator arm).
Active Comparator: Radio-chemotherapy
Concomitant radiotherapy (external radiotherapy combined with external boost or brachytherapy) and chemotherapy (cisplatin)
 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).


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival at 5 years [ Time Frame: 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00039338


Locations
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Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
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Study Chair: 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
More Information
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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00039338    
Other Study ID Numbers: EORTC-55994
2008-003396-52 ( EudraCT Number )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: December 2016
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage IB cervical cancer
stage IIB cervical cancer
stage IIA cervical cancer
 cervical squamous cell carcinoma
cervical adenocarcinoma
cervical adenosquamous cell carcinoma
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
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
Cisplatin
Antineoplastic Agents