Organ Preservation in Early Rectal Cancer Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Colorectal Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/1/2018 |
| Start Date: | May 11, 2018 |
| End Date: | March 1, 2023 |
| Contact: | Namrata Vijayvergia, MD |
| Email: | Namrata.Vijayvergia@fccc.edu |
| Phone: | 215214-1515 |
GI-116: Phase II Study of Organ Preservation in Early Rectal Cancer Patients
This is a single arm phase II study of neoadjuvant chemotherapy followed by local excision
and post-operative chemoradiotherapy in patients with early stage, low rectal adenocarcinoma.
After completion of pre-treatment tests/procedures (including pelvic MRI/ERUS; MRI is
mandatory at baseline and other imaging is encouraged) and confirmation of eligibility,
systemic therapy with FOLFOX will be administered for 12 weeks. 2 to 4 weeks after the
chemotherapy, restaging of the primary tumor will be done to evaluate response to therapy
(Pelvic MRI and /or sigmoidoscopy). Patients with disease progression or inadequate response
to chemotherapy to allow local excision will continue with evaluation and treatment per the
current standard of care (chemoradiation followed by TME). These patients will be considered
failures for the primary endpoint of the study. Patients who respond to the neoadjuvant
chemotherapy will proceed with local excision (open, TEMS or TAMIS), 6-12 weeks after the
completion of neoadjuvant chemotherapy, followed by 5-FU based chemoradiotherapy 4-12 weeks
after local excision. Patients with positive margins at the time of local excision will also
be treated as per standard of care and will be considered as failures. Number of patients who
can undergo successful local excision with this approach will define the success of the
strategy. After chemoradiation therapy post local excision, patients will be followed closely
every 3 months for the first 3 years and then every 2 months for the next 2 years
(history/physical, CEA and pelvic MRI). Patients who are deemed failures for the primary
end-point will be followed as per standard of care, off-study.
and post-operative chemoradiotherapy in patients with early stage, low rectal adenocarcinoma.
After completion of pre-treatment tests/procedures (including pelvic MRI/ERUS; MRI is
mandatory at baseline and other imaging is encouraged) and confirmation of eligibility,
systemic therapy with FOLFOX will be administered for 12 weeks. 2 to 4 weeks after the
chemotherapy, restaging of the primary tumor will be done to evaluate response to therapy
(Pelvic MRI and /or sigmoidoscopy). Patients with disease progression or inadequate response
to chemotherapy to allow local excision will continue with evaluation and treatment per the
current standard of care (chemoradiation followed by TME). These patients will be considered
failures for the primary endpoint of the study. Patients who respond to the neoadjuvant
chemotherapy will proceed with local excision (open, TEMS or TAMIS), 6-12 weeks after the
completion of neoadjuvant chemotherapy, followed by 5-FU based chemoradiotherapy 4-12 weeks
after local excision. Patients with positive margins at the time of local excision will also
be treated as per standard of care and will be considered as failures. Number of patients who
can undergo successful local excision with this approach will define the success of the
strategy. After chemoradiation therapy post local excision, patients will be followed closely
every 3 months for the first 3 years and then every 2 months for the next 2 years
(history/physical, CEA and pelvic MRI). Patients who are deemed failures for the primary
end-point will be followed as per standard of care, off-study.
Inclusion criteria
1. Histologically proven adenocarcinoma of the lower rectum (lower border ≤6 cm from anal
verge as assessed by pelvic MRI).
2. Clinical stage T1N0, T2N0, T3N0; high risk T1 and low risk T3 stage patients are also
allowed. Clinical staging should be estimated based on the combination of the
following assessments: physical exam by the primary surgeon, CT Chest/Abdomen/Pelvis
or PET/CT along with Pelvic MRI and Endoscopic Rectal Ultrasound (ERUS). If a pelvic
MRI is performed, it is acceptable to perform CT of the chest/abdomen, omitting CT
imaging of the pelvis.
3. No prior therapy for rectal cancer
4. Age > 18 years.
5. ECOG performance status 0 or 1
6. Patients must have normal organ and marrow function as defined below
- Leukocytes > 3,000/mcL
- Absolute neutrophil count > 1,500/mcL
- Platelets > 100,000/mcL
- Total bilirubin < 1.5 times ULN
- AST/ALT (SGOT/SGPT) < 3 times institutional normal limits
- Creatinine < 1.5 times ULN OR
- Creatinine clearance > 60 Ml/min/1.73 m2 for patients with creatinine levels
above institutional normal
7. Ability to understand and willingness to sign a written informed consent and HIPAA
consent document
Exclusion Criteria:
1. Patients with contraindication to use FOLFOX chemotherapy and pelvic radiation.
2. Low risk T1 tumors that fulfill all of the following - size<4 cm, lack of
lymphovascular invasion and well differentiated histology, are excluded
3. High risk T3 tumors that fulfill any of the following - circumferential tumor,
extension into mesorectal fascia > 5mm, prediction of positive circumferential
resection margin, are also excluded.
4. T4, node positive or advanced rectal adenocarcinoma. Node positivity defined as nodes
greater than 1cm in short axis with loss of uniform cortex/fatty hilum
5. Patients receiving other investigational agents
6. Patients who have had chemotherapy (for other malignancies) within 3 years prior to
registration
7. Patients with any prior pelvic radiation therapy
8. Prior malignancies requiring systemic therapy within the last 3 years (as prior
therapy can increase toxicity of current chemo regimen, those patients should be
excluded).
9. History of allergic reactions attributed to compound of similar chemical or biologic
composition to the agents used in this study
10. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.
11. Known HIV-positive patients on combination antiretroviral therapy are ineligible
because of the potential for pharmacokinetic interactions with chemotherapeutic drugs.
In addition, these patients are at increased risk of lethal infections when treated
with marrow-suppressive therapy.
12. Pregnant or breast feeding.
We found this trial at
1
site
Click here to add this to my saved trials
