Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Surgery or Chemotherapy in Recurrent Ovarian Cancer (SOC 1 Trial)?

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Shanghai Gynecologic Oncology Group
Sponsor:
Collaborators:
Fudan University
Zhejiang Cancer Hospital
Information provided by (Responsible Party):
Shanghai Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01611766
First received: May 30, 2012
Last updated: January 2, 2013
Last verified: January 2013

May 30, 2012
January 2, 2013
January 2011
January 2015   (final data collection date for primary outcome measure)
overall survival [ Time Frame: Up to 36 months after last patient randomized ] [ Designated as safety issue: No ]
overall survival [ Time Frame: Up to 36 months after last patient randomized ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01611766 on ClinicalTrials.gov Archive Site
  • Progression-free survival [ Time Frame: Progression-free survival is defined as interval between date of randomization and 2nd relapse/progression or death (whatever occurs first), assessed up to 36 months. ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: Baseline, 6, 12, and 24 months after randomization ] [ Designated as safety issue: Yes ]
  • complications incidence [ Time Frame: From the operation until after 60 days ] [ Designated as safety issue: Yes ]
  • Progression-free survival [ Time Frame: Progression-free survival is defined as interval between date of randomization and 2nd relapse/progression or death (whatever occurs first), assessed up to 120 months. ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: Baseline, 6, 12, and 24 months after randomization ] [ Designated as safety issue: No ]
  • complications incidence [ Time Frame: From the operation until after 60 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Surgery or Chemotherapy in Recurrent Ovarian Cancer (SOC 1 Trial)?
Evaluation of Secondary Cytoreductive Surgery in Platinum-Sensitive Recurrent Ovarian Cancer: A Phase III, Multicenter, Randomized Trial

The purpose of this study is to evaluate the role of secondary cytoreduction (SCR) and validate the risk model of patient selection criteria in platinum-sensitive recurrent ovarian cancer.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Ovarian Epithelial Cancer Recurrent
  • Fallopian Tube Carcinoma
  • Primary Peritoneal Carcinoma
  • Procedure: Secondary Cytoreductive Surgery
    Complete Cytoreduction
    Other Name: Debulking Surgery
  • Drug: Salvage Chemotherapy
  • Experimental: secondary cytoreductive surgery
    SCR followed by chemotherapy
    Interventions:
    • Procedure: Secondary Cytoreductive Surgery
    • Drug: Salvage Chemotherapy
  • Active Comparator: Salvage Chemotherapy
    platinum-based chemotherapy
    Intervention: Drug: Salvage Chemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
420
December 2017
January 2015   (final data collection date for primary outcome measure)

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 planned.
  • 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 therapy
  • 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 insufficiency
    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)
Female
18 Years to 80 Years
No
Contact: Xiao Huang, MD, PhD +862164175590 smilehuangxiao@163.com
Contact: Yuting Luan, RN +862164175590 fudanGOG@gmail.com; yutingluan@163.com
China
 
NCT01611766
V02_2010_10
Yes
Shanghai Gynecologic Oncology Group
Shanghai Gynecologic Oncology Group
  • Fudan University
  • Zhejiang Cancer Hospital
Principal Investigator: Rongyu Zang, MD,PhD Shanghai Gynecologic Oncology Group
Shanghai Gynecologic Oncology Group
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP