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Carboplatin in Treating Patients With Stage IC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00098878
Recruitment Status : Completed
First Posted : December 9, 2004
Last Update Posted : August 7, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This randomized phase III trial is comparing different doses of carboplatin to see how well they work in treating patients with stage IC, stage II, stage III, or stage IV ovarian, fallopian tube, or primary peritoneal cancer.

Condition or disease Intervention/treatment Phase
Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer Drug: carboplatin Phase 3

Detailed Description:



  • Compare progression-free survival of patients with stage IC-IV ovarian epithelial, fallopian tube, or primary peritoneal cancer treated with flat-dose vs intra-patient dose-escalated carboplatin as first-line chemotherapy.


  • Compare the toxic effects of these regimens in these patients.
  • Compare the quality of life of patients treated with these regimens.
  • Compare overall clinical response rate and CA 125 response in patients treated with these regimens.
  • Compare overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive a flat dose of carboplatin on day 1.
  • Arm II: Patients receive intra-patient dose-escalated carboplatin on day 1. In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before each treatment course, and then at 2 months post-chemotherapy.

Patients are followed every 2 months for 2 years, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 1,300 patients (650 per treatment arm) will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1300 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: SCOTROC 4: A Prospective, Multicentre, Randomised Trial Of Carboplatin Flat Dosing Vs Intrapatient Dose Escalation In First Line Chemotherapy Of Ovarian, Fallopian Tube And Primary Peritoneal Cancers
Study Start Date : March 2004
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Primary Outcome Measures :
  1. Progression-free survival

Secondary Outcome Measures :
  1. Toxicity
  2. Quality of life
  3. Clinical overall response rate and CA125 response
  4. Overall survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer*

    • Stage IC-IV disease
    • Peritoneal carcinomatosis* (ovarian-type) must not be a mucin-secreting tumor
    • Stage IC patients must have malignant cells in ascitic fluid or peritoneal washings, tumor on the surface of the ovary, or preoperative capsule rupture NOTE: * Histologic confirmation of a primary source in the ovary is not required.
  • If biospy is not available, cytology showing an adenocarcinoma is allowed provided the following criteria is met:

    • Patient has a pelvis (ovarian) mass AND all of the following:

      • Omental cake or other metastasis is larger than 2 cm in the upper abdomen and/or regional lymph node metastasis irrespective of size OR stage IV disease
      • Serum CA 125/CEA ratio > 25 or barium enema (or colonoscopy) and gastroscopy (or radiological examination of the stomach) are negative for the presence of a primary tumor and normal mammography within 6 weeks prior to study randomization
  • Initial cytoreductive laparotomy or biopsy required within the past 8 weeks

    • Cytoreductive surgery may or may not have been successful during staging laparotomy
  • No mixed mesodermal tumors
  • No borderline ovarian tumors or tumors termed "possibly malignant"
  • No adenocarcinoma of unknown origin, if histologically confirmed to be a mucin-secreting tumor
  • Considered unsuitable for or unwilling to receive platinum-taxane combination therapy
  • No concurrent endometrial cancer



  • 18 and over

Performance status

  • ECOG 0-3

Life expectancy

  • Not specified


  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3


  • Bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 5 times ULN


  • Creatinine clearance ≥ 30 mL/min

    • Obstructive hydronephrosis as a cause of borderline (i.e., creatinine clearance 30-45 mL/min) renal function must be treated before study entry


  • No hypertension
  • No ischemic heart disease
  • No myocardial infarction within the past 6 months
  • No congestive heart failure


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No symptomatic peripheral neuropathy ≥ grade 2
  • No uncontrolled infection
  • No other severe and/or uncontrolled medical condition
  • No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer


Biologic therapy

  • Not specified


  • No prior chemotherapy
  • No other concurrent cytotoxic chemotherapy until progressive disease occurs

Endocrine therapy

  • Not specified


  • No prior radiotherapy


  • See Disease Characteristics

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 identifier (NCT number): NCT00098878

Show Show 88 study locations
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
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Study Chair: Stanley B. Kaye, MD, FRCP Royal Marsden NHS Foundation Trust
Layout table for additonal information Identifier: NCT00098878    
Other Study ID Numbers: SCOTTISH-SCOTROC-4
CDR0000396778 ( Registry Identifier: PDQ (Physician Data Query) )
ISRCTN47645935 ( Registry Identifier: ISRCTN (International Standard Randomised Controlled Trial Number Register) )
First Posted: December 9, 2004    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: July 2009
Keywords provided by National Cancer Institute (NCI):
stage I ovarian epithelial cancer
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
fallopian tube cancer
primary peritoneal cavity cancer
Additional relevant MeSH terms:
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Fallopian Tube Neoplasms
Neoplasms by Site
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Fallopian Tube Diseases
Antineoplastic Agents