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

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ClinicalTrials.gov Identifier: NCT01611766
Recruitment Status : Active, not recruiting
First Posted : June 5, 2012
Last Update Posted : June 10, 2021
Sponsor:
Collaborators:
Fudan University
Zhejiang Cancer Hospital
Shanghai Zhongshan Hospital
Sun Yat-sen University
Information provided by (Responsible Party):
Shanghai Gynecologic Oncology Group

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ovarian Epithelial Cancer Recurrent Fallopian Tube Carcinoma Primary Peritoneal Carcinoma Procedure: Secondary Cytoreductive Surgery Drug: Salvage Chemotherapy Phase 3

Detailed Description:
The primary objective is to determine whether secondary cytoreduction followed by chemotherapy is superior to chemotherapy alone in improving progression-free survival (PFS) and overall survival (OS) in patients with platinum-sensitive recurrent ovarian cancer

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 356 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Secondary Cytoreductive Surgery in Platinum-Sensitive Recurrent Ovarian Cancer: A Phase III, Multicenter, Randomized Trial
Actual Study Start Date : July 19, 2012
Actual Primary Completion Date : December 2019
Estimated Study Completion Date : December 2022


Arm Intervention/treatment
Experimental: secondary cytoreductive surgery
SCR followed by chemotherapy
Procedure: Secondary Cytoreductive Surgery
Complete Cytoreduction
Other Name: Maximum effort cytoreductive surgery

Drug: Salvage Chemotherapy
6 cycles of postoperative chemotherapy
Other Name: second line chemotherapy

Active Comparator: Salvage Chemotherapy
platinum-based chemotherapy
Drug: Salvage Chemotherapy
6 cycles of postoperative chemotherapy
Other Name: second line chemotherapy




Primary Outcome Measures :
  1. Overall survival [ Time Frame: Up to 60 months after last patient randomized ]
    from date of randomisation until death

  2. Progression-free survival [ Time Frame: Up to 24 months after last patient randomized ]
    interval between date of randomization and the date of second relapse/ progression or death, whatever occurs first


Secondary Outcome Measures :
  1. Accumulating Treatment-free survival (TFSa) [ Time Frame: Up to 60 months after last patient randomized ]
    the time of OS minus each treatment period after randomization, including surgery and chemotherapy

  2. Overall survival after the adjustment of one-way treatment switching [ Time Frame: Up to 60 months after last patient randomized ]
    OS adjusted by statistical models for crossover

  3. 30-day post-operative complications [ Time Frame: From the operation until after 30 days ]
    MSKCC surgical complications grading method and CTCAE v4.03 criteria will be adopted for evaluating the perioperative complications

  4. Validation of iMODEL [ Time Frame: From randomization to operation ]
    iMODEL score to predict complete resection

  5. Patient compliance [ Time Frame: Up to 60 months after last patient randomized ]
    compliance with protocol

  6. Quality of life assessments [ Time Frame: Study entry; 6 months; 12 months; 24 months and 60 months after randomization ]
    The EORTC core quality of life questionnaire (QLQ-C30, version 3.0) Functional Assessment of Cancer Therapy- Ovary (FACT-O)

  7. Time to first subsequent anticancer therapy [ Time Frame: Up to 60 months after last patient randomized ]
    From date of randomization until the date of first recurrent anticancer therapy

  8. Time to second subsequent anticancer therapy [ Time Frame: Up to 60 months after last patient randomized ]
    From date of randomization until the date of secondary recurrent anticancer therapy



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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). If PI and CO-PI reach consensus that the recurrent tumor detected by PET/CT could be completely resected, the index of CA125 could be scored as 0. (Revised on 09/30/2013)
  • 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.

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 ClinicalTrials.gov identifier (NCT number): NCT01611766


Locations
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China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
China, Shanghai
Fudan University Cancer Hospital
Shanghai, Shanghai, China, 200032
Shanghai Zhongshan Hospital
Shanghai, Shanghai, China, 200032
China, Zhejiang
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Sponsors and Collaborators
Shanghai Gynecologic Oncology Group
Fudan University
Zhejiang Cancer Hospital
Shanghai Zhongshan Hospital
Sun Yat-sen University
Investigators
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Principal Investigator: Rongyu Zang, MD,PhD Shanghai Gynecologic Oncology Group
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shanghai Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01611766    
Other Study ID Numbers: SGOG OV 2
SGOG OV2 ( Other Identifier: SGOG )
First Posted: June 5, 2012    Key Record Dates
Last Update Posted: June 10, 2021
Last Verified: June 2021
Keywords provided by Shanghai Gynecologic Oncology Group:
secondary cytoreductive surgery
Ovarian Cancer
surgery
recurrence
Additional relevant MeSH terms:
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Carcinoma
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders