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

Shanghai Gynecologic Oncology Group

Status and phase: Unknown; Phase 3

Conditions: Ovarian Epithelial Cancer Recurrent; Primary Peritoneal Carcinoma; Fallopian Tube Carcinoma

Treatments: Procedure: Secondary Cytoreductive Surgery; Drug: Salvage Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01611766

SGOG OV2 (Other Identifier)

SGOG OV 2

Details and patient eligibility

About

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.

Full 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

Enrollment: 356 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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356 participants in 2 patient groups

secondary cytoreductive surgery

Experimental group

Description:

SCR followed by chemotherapy

Treatment:

Drug: Salvage Chemotherapy

Procedure: Secondary Cytoreductive Surgery

Salvage Chemotherapy

Active Comparator group

Description:

platinum-based chemotherapy

Treatment:

Drug: Salvage Chemotherapy