PROTOCOL ACRIN 6695 Minimize

GOG-0262/ACRIN 6695: Prognostic Perfusion CT in Gynecological Cancer:
A Randomized Phase III Trial of Every-3-Weeks Paclitaxel versus Dose Dense
Weekly Paclitaxel in Combination with Carboplatin with or without Concurrent
and Consolidation Bevacizumab in the Treatment of Primary Stage I, II, III, or IV
Epithelial Ovarian, Peritoneal, or Fallopian Tube Cancer

Protocol Documents 

Protocol-GOG-0262/ACRIN 6695, v9.26.12 (effective 10.22.12) [PDF]

SOC Revision #6-GOG-0262/ACRIN 6695, v9.26.12 (effective 10.22.12) [PDF]

Informed Consent-ACRIN 6695, v9.26.12 [DOC]

ACRIN Principal Co-Investigators: Chaan Ng, MD; Ting Yim Lee, PhD; and Robert Coleman, MD

Status: In Analysis

Overview: By adding functional imaging to the master treatment study, there is a potential
to identify the quantitative functional parameters of perfusion CT that may act as early predictors
of patient response to therapy, progression-free survival, and overall survival in ovarian cancer.
The data obtained from early imaging are important to the development of early quantitative
markers of tumor response and patient outcome to chemotherapy. This proof-of-concept study
will demonstrate that derived functional parameters from perfusion CT imaging may act as
surrogate markers of ovarian cancer response to chemotherapy and as predictors of patient outcomes.

Main Objectives: The main objectives of the imaging study (ACRIN 6695) is to determine changes
in tumor perfusion parameters as quantified by: vascularity or blood volume (BV); perfusion or
blood flow (BF); mean transit time (MTT); and microvascular permeability or permeability surface
area product (PS), from baseline (T0) to at the end of cycle 1 chemotherapy (T1), T0 to after the
start of cycle 2 chemotherapy/anti-angiogenic therapy (T2), and T1 to T2.

Study Design Summary:
In this extension to the master GOG-0262 treatment study, ACRIN
will perform three perfusion CT imaging examinations to evaluate the patient's response to
chemotherapy and anti-angiogenic therapy. Perfusion CT imaging will be performed at baseline (T0)
prior to chemotherapy, at the end of cycle 1 chemotherapy (T1), and after the start of cycle 2
chemotherapy/anti-angiogenic therapy (T2).

The GOG-0262/ACRIN 6695 study was amended to allow ACRIN to accrue additional patients
and meet its accrual goals for its primary analyses for the advanced imaging aims. As GOG has
completed its accrual for their needs, additional changes have been incorporated into the protocol.
The changes include: 

  • Patient participation in the ACRIN 6695 portion of the study is now a mandatory component
    of GOG 0262. A combined Informed Consent will be used in this extension.
  • Patients are eligible for participation if they are: suboptimally debulked disease (≥ 1cm)
    or plan to receive neoadjuvant chemotherapy followed by cytoreductive surgery. Optimally
    debulked patients (< 1cm) will not be eligible for participation.
  • No randomization will occur between chemotherapy arms. Chemotherapy regimens will be
    assigned at the discretion of the treating institution.
  • No translational research or quality of life research will be performed in the extension.

Participants: ACRIN will accrue data from 78 eligible and evaluable participants.

In addition to meeting the criteria of GOG 0262 (planned neoadjuvant chemotherapy followed by
cytoreductive surgery or sub-optimally debulked disease [FIGO Stages I, II, III or IV]), patients must
have at least one tumor/metastasis satisfying the following criteria:

  • Lesion size larger than 1 cm residual (“suboptimally debulked” disease) in both the short and
    long axes in the abdomen or the pelvis as determined by non-contrast enhanced CT at first
    radiographic imaging;
  • At least half of the lesion has an attenuation of a least 10 HU in the qualifying pre-contrast CT scan;
  • At least half of the lesion has a maximum enhancement of at least 5 HU in the first CT perfusion scan.