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Evaluation of Secondary Cytoreductive Surgery in Platinum-Sensitive Recurrent Ovarian Cancer: A Phase III, Multicenter, Randomized Trial

Phase 3
18 Years
80 Years
Open (Enrolling)
Ovarian Epithelial Cancer Recurrent, Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma

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Trial Information

Evaluation of Secondary Cytoreductive Surgery in Platinum-Sensitive Recurrent Ovarian Cancer: A Phase III, Multicenter, Randomized Trial

The primary objective of this study is to compare overall survival (OS) in patients with
platinum-sensitive recurrent ovarian cancer with a positive SCR score randomized to
secondary cytoreductive surgery followed by chemotherapy versus chemotherapy alone.

Inclusion Criteria:

- Age at recurrence ≥ 18 years

- Patients with platinum-sensitive, first relapsed epithelial ovarian, primary
peritoneal, or fallopian tube cancer (EOC, PPC, FTC), which is defined as those with
treatment -free interval of 6 months or more.

- A complete secondary cytoreduction predicting score, iMODEL [Tian WJ, Ann Surg Oncol
2012,19(2):597-604]<=4.7, including FIGO stage (0 or 0.8); residual disease after
primary surgery (0 or 1.5); Progression-free interval (0 or 2.4); PS ECOG (0 or 2.4);
Ca125 (0 or 1.8); and ascites at recurrence (0 or 3.0).

- Assessed by the experienced surgeons, complete resection of all recurrent disease is
possible. If single lesion outside the peritoneal cavity can be resected, MRI/CT or
PET/CT scan should be performed to exclude simultaneous intra-abdominal lesions.

- Patients who have given their signed and written informed consent and their consent.

Exclusion Criteria:

- Patients with borderline tumors as well as non-epithelial tumors.

- Patients for interval-debulking, or for second-look surgery, or palliative surgery

- Impossible to assess the resectability or evaluate the score. Radiological signs
suggesting complete resection is impossible.

- More than one prior chemotherapy.

- Second relapse or more

- Patients with second or other malignancies who have been treated by surgery, if the
treatment might interfere with the treatment of relapsed ovarian cancer or if major
impact on prognosis is expected.

- Progression during chemotherapy or recurrence within 6 months after first-line

- Any contradiction not allowing surgery and/or chemotherapy

1. Accompanied by hypoxia serious chronic obstructive pulmonary disease

2. Uncontrolled hypertension, cerebrovascular accident/ Stroke, myocardial infarct,
unstable angina, untreated thrombosis, chronic congestive heart failure, or
serious arrhythmia in need of medicine.

3. Severe hepatitis, history of liver disease, nephrotic syndrome, renal

4. Active ulcer history, abdominal wall fistula, perforation of gastrointestinal
tract, or Intra-abdominal abscess, or simultaneously apply treatment/prevent
ulcers therapy.

5. Uncontrolled diabetes

6. Uncontrolled epilepsy need long-term antiepileptic treatment.

- Any medication induced considerable risk of surgery, e.g. estimated bleeding due to
oral anticoagulating agents, or bevacizumab)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Time Frame:

Up to 36 months after last patient randomized

Safety Issue:


Principal Investigator

Rongyu Zang, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Shanghai Gynecologic Oncology Group


China: Ethics Committee

Study ID:




Start Date:

January 2011

Completion Date:

December 2017

Related Keywords:

  • Ovarian Epithelial Cancer Recurrent
  • Fallopian Tube Carcinoma
  • Primary Peritoneal Carcinoma
  • secondary cytoreductive surgery
  • Ovarian Cancer
  • surgery
  • recurrence
  • Carcinoma
  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial