NCT01611766 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE3
Status at capture: UNKNOWN
Registry last update: 2021-06-10

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part

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.
healthy Volunteers: false
maximum Age: 80 Years
minimum Age: 18 Years
sex: FEMALE
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
SCR followed by chemotherapy
intervention Names
Procedure: Secondary Cytoreductive Surgery
Drug: Salvage Chemotherapy
label
secondary cytoreductive surgery
type
EXPERIMENTAL
description
platinum-based chemotherapy
intervention Names
Drug: Salvage Chemotherapy
label
Salvage Chemotherapy
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
secondary cytoreductive surgery
description
Complete Cytoreduction
name
Secondary Cytoreductive Surgery
other Names
Maximum effort cytoreductive surgery
type
PROCEDURE
arm Group Labels
Salvage Chemotherapy
secondary cytoreductive surgery
description
6 cycles of postoperative chemotherapy
name
Salvage Chemotherapy
other Names
second line chemotherapy
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 356
type: ESTIMATED

Registered outcome plans (not posted results)

primary Outcomes

description
from date of randomisation until death
measure
Overall survival
time Frame
Up to 60 months after last patient randomized
description
interval between date of randomization and the date of second relapse/ progression or death, whatever occurs first
measure
Progression-free survival
time Frame
Up to 24 months after last patient randomized

secondary Outcomes

description
the time of OS minus each treatment period after randomization, including surgery and chemotherapy
measure
Accumulating Treatment-free survival (TFSa)
time Frame
Up to 60 months after last patient randomized
description
OS adjusted by statistical models for crossover
measure
Overall survival after the adjustment of one-way treatment switching
time Frame
Up to 60 months after last patient randomized
description
MSKCC surgical complications grading method and CTCAE v4.03 criteria will be adopted for evaluating the perioperative complications
measure
30-day post-operative complications
time Frame
From the operation until after 30 days
description
iMODEL score to predict complete resection
measure
Validation of iMODEL
time Frame
From randomization to operation
description
compliance with protocol
measure
Patient compliance
time Frame
Up to 60 months after last patient randomized
description
The EORTC core quality of life questionnaire (QLQ-C30, version 3.0) Functional Assessment of Cancer Therapy- Ovary (FACT-O)
measure
Quality of life assessments
time Frame
Study entry; 6 months; 12 months; 24 months and 60 months after randomization
description
From date of randomization until the date of first recurrent anticancer therapy
measure
Time to first subsequent anticancer therapy
time Frame
Up to 60 months after last patient randomized
description
From date of randomization until the date of secondary recurrent anticancer therapy
measure
Time to second subsequent anticancer therapy
time Frame
Up to 60 months after last patient randomized

Full study description

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

Source references

references

citation
Jiang R, Feng Y, Chen Y, Cheng X, Shi T, Gao W, Jia H, Jiang S, Guo Y, Huang X, Tu D, Zhang Y, Yang H, Zhang P, Liu J, Zhu J, Zang R; SOC-1 Investigators. Surgery versus no surgery in platinum-sensitive relapsed ovarian cancer: final overall survival analysis of the SOC-1 randomized phase 3 trial. Nat Med. 2024 Aug;30(8):2181-2188. doi: 10.1038/s41591-024-02981-0. Epub 2024 Jun 1.
pmid
38824243
type
DERIVED
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.
pmid
33705695
type
DERIVED