Clinical trial NCT01611766: Surgery or Chemotherapy in Recurrent Ovarian Cancer (SOC 1 Trial)?
Official title: Evaluation of Secondary Cytoreductive Surgery in Platinum-Sensitive Recurrent Ovarian Cancer: A Phase III, Multicenter, Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Ovarian Epithelial Cancer Recurrent
Fallopian Tube Carcinoma
Primary Peritoneal Carcinoma
Keywords: secondary cytoreductive surgery
Ovarian Cancer
surgery
recurrence
Lead sponsor: Shanghai Gynecologic Oncology Group
Sponsor class: OTHER_GOV
Collaborators: name: Fudan University
name: Zhejiang Cancer Hospital
name: Shanghai Zhongshan Hospital
name: Sun Yat-sen University
First posted: 2012-06-05
Enrollment: 356
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility 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.

Primary outcomes:
measure: Overall survival
timeFrame: Up to 60 months after last patient randomized
measure: Progression-free survival
timeFrame: Up to 24 months after last patient randomized
Secondary outcomes:
measure: Accumulating Treatment-free survival (TFSa)
timeFrame: Up to 60 months after last patient randomized
measure: Overall survival after the adjustment of one-way treatment switching
timeFrame: Up to 60 months after last patient randomized
measure: 30-day post-operative complications
timeFrame: From the operation until after 30 days
measure: Validation of iMODEL
timeFrame: From randomization to operation
measure: Patient compliance
timeFrame: Up to 60 months after last patient randomized
measure: Quality of life assessments
timeFrame: Study entry; 6 months; 12 months; 24 months and 60 months after randomization
measure: Time to first subsequent anticancer therapy
timeFrame: Up to 60 months after last patient randomized
measure: Time to second subsequent anticancer therapy
timeFrame: Up to 60 months after last patient randomized
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
state: Shanghai
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Shanghai Gynecologic Oncology Group
name: Rongyu Zang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shi T, Zhu J, Feng Y, Tu D, Zhang Y, Zhang P, Jia H, Huang X, Cai Y, Yin S, Jiang R, Tian W, Gao W, Liu J, Yang H, Cheng X, Zang R. Secondary cytoreduction followed by chemotherapy versus chemotherapy alone in platinum-sensitive relapsed ovarian cancer (SOC-1): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Apr;22(4):439-449. doi: 10.1016/S1470-2045(21)00006-1. Epub 2021 Mar 8.