Clinical trial · Interventional
Pelvic Radiotherapy With Concurrent Neoadjuvant FOLFOX for Patients With Newly Diagnosed Rectal Adenocarcinoma
Phase II Trial of Low Dose Whole Pelvic Radiotherapy With Concurrent Neoadjuvant FOLFOX for Patients With Newly Diagnosed T3N0M0, T2N1M0, or T3N1M0 Rectal Adenocarcinoma
NCT02319304CI-TRIAL-00054866GCC 1314terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual, PI left instituion
Summary
Brief summary (as posted)
The purpose of this study is to assess the effects, both good and bad, of adding very low dose fractionated radiation therapy (LDFRT) to the pelvis, with FOLFOX chemotherapy prior to surgery. Standard pelvic radiation therapy given once a day (Monday through Friday) over approximately 5.5 weeks is not given in this study. You will receive 6 cycles of FOLFOX (each cycle is 2 weeks) and you will also get an LDFRT to your pelvis given twice a day on the first two days of each cycle.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Adenocarcinoma | Rectal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFOX {5-fluorouracil (5-FU), leucovorin, and oxaliplatin} | Drug | — | UNRESOLVED |
| Low dose fractionated radiation therapy (LDFRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Pelvic Radiotherapy With Concurrent Neoadjuvant FOLFOX
- description
- Part I: FOLFOX: combination of drugs administered in a specific sequence as prescribed below. * Oxaliplatin: 85 mg/m2 intravenously (IV) over 2 hours * Leucovorin: 200 mg/m2 IV bolus over 2 hours * 5-FU: 400 mg/m2 IV bolus over 5-15 minutes, then 2,400 mg/m2 continuous IV infusion over 46-48 hours Part II: Low dose fractionated radiation therapy (LDFRT) Intensity-modulated, bone marrow sparing, whole pelvic radiation therapy 40 cGy fractions twice per day delivered at least 4-6 hours apart on the first 2 days of each chemotherapy cycle for a total of 6 cycles
- interventionNames
- Drug: FOLFOX {5-fluorouracil (5-FU), leucovorin, and oxaliplatin}
- Radiation: Low dose fractionated radiation therapy (LDFRT)
Primary outcomes (1)
- measure
- Primary Outcome Measure (Overall Survival Rate)
- timeFrame
- 1 year
- description
- Overall survival rate of patients who receive a neoadjuvant full dose FOLFOX plus the addition of concurrent LDFRT result in a pCR response rate of at least 35%.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
1. ≥ 18 years old at diagnosis.
2. ECOG Performance Status 0, 1, or 2.
3. Biopsy-proven diagnosis of rectal adenocarcinoma.
4. Radiographically measurable or clinically evaluable disease by CT scan of chest/abdomen/pelvis with and without contrast ≤ 28 days prior to registration.
5. Clinical AJCC 7th edition stage T2N1M0, T3N0M0 or T3N1M0 based on physical examination, CT scan chest/abdomen/pelvis, and pelvic MRI or endorectal ultrasound.
6. Preoperative proctoscopy confirming tumor extent as no less than 5 cm and no greater than 12 cm from the anal verge.
7. Evaluation by a surgical oncologist, radiation oncologist, and medical oncologist ≤ 28 days prior to registration.
8. Confirmation by a surgeon that the patient is able to undergo a low anterior resection with total mesorectal excision ≤ 28 days prior to registration.
9. In the absence of a being treated on a clinical trial, the patient would be recommended to receive neoadjuvant chemoradiation followed by curative intent surgery.
10. The following laboratory values obtained ≤ 28 days prior to registration:
* Absolute neutrophil count (ANC) ≥ 1500/mm3.
* Platelet count ≥ 100,000/mm3.
* Hemoglobin \> 8.0 g/dL. May transfuse to meet eligibility.
* 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.
11. Negative pregnancy test (B-HCG) within 7 days prior to registration for women of childbearing potential.
12. Did the patient provide study-specific informed consent prior to study entry?
13. Willingness to return to the enrolling medical site for all study assessments.
Exclusion Criteria:
1. Clinical T4 tumor.
2. Primary surgeon indicates the need for an abdominal perineal resection (APR) at baseline.
3. Previous pelvic RT.
4. Autoimmune disease such as scleroderma, lupus, or inflammatory bowel disease.
5. Tumor \< 3 mm from the mesorectal fascia as seen on MRI or endorectal ultrasound.
6. Tumor-induced symptomatic bowel obstruction.
7. Chemotherapy (including hormonal therapy) within the past 5 years from date of registration.
8. Other invasive malignancies within past 5 years from date of registration.
9. Pregnant or nursing women.
10. Men or women of childbearing potential who are unwilling to employ adequate contraception.
11. Other co-morbid conditions that, based on the judgment of the physicians obtaining informed consent, would make the patient inappropriate for this study.
12. Any conditions that would preclude a patient from completing all study assessments.References
Publications (0)
Data not yet available
No reference posted for this study.