Know Cancer

forgot password

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

Phase 3
18 Years
Open (Enrolling)
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

Thank you

Trial Information

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



- 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

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.

Inclusion Criteria


- Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal

- 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

- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Safety Issue:


Principal Investigator

Stanley B. Kaye, MD, FRCP

Investigator Role:

Study Chair

Investigator Affiliation:

Royal Marsden NHS Foundation Trust


United States: Federal Government

Study ID:




Start Date:

March 2004

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • stage I ovarian epithelial cancer
  • stage II ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • fallopian tube cancer
  • peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms