Description:
TASOX can be safely and efficaciously delivered after short course radiation, resulting in
significant pathologic downstaging, allowing for an R0 pelvic resection, and providing local
control in appropriately selected stage II/III rectal cancer patients treated with
contemporary TME-based surgery.
Title
- Brief Title: SHOrt Course Radiation and TASOX (TAS102 Plus Oxaliplatin) Chemotherapy in Operable Rectal Cancer
- Official Title: SHORT: SHOrt Course Radiation and TASOX (TAS102 Plus Oxaliplatin) Chemotherapy in Operable Rectal Cancer, a Phase II Trial.
Clinical Trial IDs
- ORG STUDY ID:
CRP18085
- NCT ID:
NCT04417699
Conditions
Interventions
Drug | Synonyms | Arms |
---|
TAS 102 | | TAS102 plus Oxaliplatin |
Oxaliplatin | | TAS102 plus Oxaliplatin |
Purpose
TASOX can be safely and efficaciously delivered after short course radiation, resulting in
significant pathologic downstaging, allowing for an R0 pelvic resection, and providing local
control in appropriately selected stage II/III rectal cancer patients treated with
contemporary TME-based surgery.
Detailed Description
In this phase II study patients will be treated with short-course preoperative irradiation
(25 Gy in five fractions of 5 Gy) followed by 6 (six) 2-week cycles of TASOX followed by
total mesorectal excision (TME) for patients with resectable rectal cancer (clinical T3c/dN0,
T3c/dN1, T2N1). Eligible study subjects include adults who are candidates for curative intent
sphincter-sparing surgery and lack high risk features such as tumor encroaching upon the
mesorectal-fascia or low tumors who need an Abdominal-Perineal Resection (APR).
Trial Arms
Name | Type | Description | Interventions |
---|
TAS102 plus Oxaliplatin | Experimental | Oxaliplatin 85mg/m2 IV over 2 hours and TAS-102 (35 mg/m2/dose) orally BID | |
Eligibility Criteria
Inclusion Criteria:
1. Age of at least 18 years.
2. Newly diagnosis of rectal adenocarcinoma.
3. ECOG Performance Status (PS): 0, 1 or 2.
4. Candidate for sphincter-sparing surgical resection prior to initiation of neoadjuvant
therapy according to the primary surgeon.
5. Clinical Stage: T1/N1, T2/N1, T3/N1, T3c/dN0.
6. Absence of metastatic disease. Clinical staging is based on physical exam by the
primary surgeon, CT scan of the chest/abdomen, and pelvic MRI.
Node positivity determination: Entry criteria nodes will be measured in short-axis
diameter and for the purposes of study entry will be considered positive if 8 mm or
greater in short axis.
Radiographic N2 status is estimated as: 4 or more nodes that measure 8mm or more in
short-axis.
Radiographic N1 status is estimated as: fewer than 4 lymph nodes that measure 8 mm or
greater in short axis but 1 or more lymph nodes that measure 8 mm or greater.
Nodal Metastatic Disease: nodal stations considered suspicious for metastatic disease
(M1) for rectal cancer are common iliac, external iliac and inguinal nodes.
7. No evidence of tumor that is adherent to the mesorectal fascia and the ability to
perform a curative intent sphincter-sparing TME resection at diagnosis. See exclusion
criterion 4
8. The following laboratory values obtained ≤ 28 days prior to registration.
- Platelet count ≥ 100,000/mm^3
- Hemoglobin > 8.0 g/dL
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- SGOT (AST) ≤ 3 x ULN
- SGPT (ALT) ≤ 3 x ULN
- Creatinine ≤1.5 x ULN
9. Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing
potential only.
10. A patient of child-bearing potential is willing to employ adequate contraception. It
includes any of the followings: abstinence, oral contraceptives, implantable hormonal
contraceptives, or double barrier method (diaphragm plus condom). See exclusion
criterion 8
11. Provide informed written consent.
12. Willing to return to enrolling medical site for all study assessments.
Exclusion Criteria:
1. Clinical T4 tumors.
2. Clinical N2 disease estimated as four or more lymph nodes that are ≥8 mm.
3. Primary surgeon indicates need for abdominoperineal (APR) at baseline.
4. Evidence that the tumor is adherent to or invading the mesorectal fascia on imaging
studies such that the surgeon would not be able to perform an R0 resection (one with
negative margins).
Distance of the Tumor from the Mesorectal Fascia:
Patients with tumors with a distance of 1mm or less from the mesorectal fascia
reflection have threatened radial margins and are ineligible.
5. Tumor is causing symptomatic bowel obstruction or patients who have had a temporary
diverting ostomy are ineligible.
6. Chemotherapy within 5 years prior to registration. (Hormonal therapy is allowable if
the disease free interval is ≥ 5 years.)
7. Any prior pelvic radiation.
8. Any of the following because this study involves an agent that has known genotoxic,
mutagenic and teratogenic effects:
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate
contraception
9. Co-morbid illnesses or other concurrent disease which, in the judgment of the treating
investigator obtaining informed consent, would make the patient inappropriate for
entry into this study or interfere significantly with the proper assessment of safety
and toxicity of the prescribed regimens.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Achieve a reduction by at least 5.8 in Neoadjuvant Response (NAR) score compared to historic controls with NAR of 14.59 |
Time Frame: | Through study completion, an average of 6 months |
Safety Issue: | |
Description: | determine whether pre-operative short-course radiation therapy (SRT) and 6 cycles of TASOX offers condensed radiation and total neoadjuvant therapy for intermediate risk rectal cancer. |
Secondary Outcome Measures
Measure: | Safety and Tolerability |
Time Frame: | Through study completion, an average of 6 months |
Safety Issue: | |
Description: | The secondary objective is to describe Incidence of Treatment-Emergent Adverse Events and surgery complications among treated subjects. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Benaroya Research Institute |
Trial Keywords
- SHORT
- short course radiation,
- TASOX
Last Updated
March 16, 2021