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NCT00039338 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
UNKNOWN
Registry last update
2016-12-05

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility 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
healthy Volunteers
false
maximum Age
75 Years
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    neoadjuvant chemotherapy (Cisplatin) followed by surgery (radial hysterectomy)
    intervention Names
    1. Procedure: conventional surgery
    2. Procedure: neoadjuvant chemotherapy
    3. Drug: cisplatin
    label
    Chemotherapy followed by surgery
    type
    EXPERIMENTAL
  2. description
    Concomitant radiotherapy (external radiotherapy combined with external boost or brachytherapy) and chemotherapy (cisplatin)
    intervention Names
    1. Procedure: neoadjuvant chemotherapy
    2. Radiation: brachytherapy
    3. Radiation: radiation therapy
    4. Drug: cisplatin
    label
    Radio-chemotherapy
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Chemotherapy followed by surgery
    description
    Radial hysterectomy
    name
    conventional surgery
    type
    PROCEDURE
  2. arm Group Labels
    1. Chemotherapy followed by surgery
    2. Radio-chemotherapy
    description
    Experimental arm: minimal cumulative cisplatin dose of 225 mg/m2. Comparator arm: cumulative cisplatin dose of 200-240 mg/m2.
    name
    neoadjuvant chemotherapy
    type
    PROCEDURE
  3. arm Group Labels
    1. Radio-chemotherapy
    description
    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.
    name
    brachytherapy
    type
    RADIATION
  4. arm Group Labels
    1. Radio-chemotherapy
    description
    Between 45-50 Gy, in fractions of 1.8 to 2 Gy.
    name
    radiation therapy
    type
    RADIATION
  5. arm Group Labels
    1. Chemotherapy followed by surgery
    2. Radio-chemotherapy
    description
    Minimal cumulative 225 mg/m2 (experimental arm). Cumulative 200-240 mg/m2 (comparator arm).
    name
    cisplatin
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
686
type
ESTIMATED
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Overall survival at 5 years
    time Frame
    5 years
Full study description
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.
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.
Source references
references
  1. citation
    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
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        rimental arm was only noted for participants with early-stage disease (stages IB, IIA, or IIB).</p> <p id="_705" tabindex="-1"><a href="/clinicaltrials/NCT00039338">EORTC-55994</a> (NCT00039338) randomly assigned patients with stages IB2, IIA2, and IIB cervical cancer to standard chemoradiation or neoadjuvant chemotherap
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        r participants with early-stage disease (stages IB, IIA, or IIB).</p> <p id="_705" tabindex="-1"><a href="/clinicaltrials/NCT00039338">EORTC-55994</a> (NCT00039338) randomly assigned patients with stages IB2, IIA2, and IIB cervical cancer to standard chemoradiation or neoadjuvant chemotherapy (with a cisplatin backbone f
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        ental arm was only noted for participants with early-stage disease (stages IB, IIA, or IIB). </p> <p id="_782" tabindex="-1"><a href="/clinicaltrials/NCT00039338">EORTC-55994</a> (NCT00039338) randomly assigned patients with stages IB2, IIA2, and IIB cervical cancer to standard chemoradiation or neoadjuvant chemotherapy
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      4. context exact
        articipants with early-stage disease (stages IB, IIA, or IIB). </p> <p id="_782" tabindex="-1"><a href="/clinicaltrials/NCT00039338">EORTC-55994</a> (NCT00039338) randomly assigned patients with stages IB2, IIA2, and IIB cervical cancer to standard chemoradiation or neoadjuvant chemotherapy (with a cisplatin backbone fo
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      source title
      Cervical Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: May 13, 2025
        datetime
        2025-05-13T12:00:00Z
        display
        May 13, 2025

    Preserved source evidence · Not medical advice